HK40045728B - Annuloplasty systems and locking tools therefor - Google Patents

Description

Lobe ring forming system and its locking tool

Cross-references to related applications

This application claims priority in the following areas:

a) U.S. Provisional Patent Application No. 62/697,186, filed July 12, 2018, entitled “Annuloplasty system and locking tool therefor”, granted to Brauon et al.; and

b) U.S. Provisional Patent Application No. 62/811,693, entitled “Annuloplasty system and locking tool therefor,” filed on February 28, 2019, and granted to Brauon et al.

The two applications are incorporated herein by reference.

Technical Field

This invention generally relates to valve repair, such as the repair of atrioventricular valves in patients.

Background Technology

Ischemic heart disease can cause valvular regurgitation. For example, mitral regurgitation may be caused by a combination of ischemic dysfunction of the papillary muscles, left ventricular dilation present in ischemic heart disease, and subsequent displacement of the papillary muscles and dilation of the mitral annulus.

The dilation of the mitral valve annulus prevents the valvular leaflets from fully aligning when the valve closes. The mitral valve regurgitation of blood from the left ventricle to the left atrium leads to an increase in total stroke volume and a decrease in cardiac output, as well as the eventual weakening of the left ventricle due to left atrial volume overload and pressure overload.

Summary of the Invention

The summary is intended to provide examples and is not intended to limit the scope of the invention in any way. For example, any feature included in the examples of the summary is not required by the claims unless those features are expressly recited in the claims. Furthermore, features, components, steps, concepts, etc., described in the examples of the summary and elsewhere in this disclosure can be combined in various ways. The description herein relates to systems, components, methods, apparatuses, devices, combinations, etc., that can be used for valve repair. Various features and steps as described elsewhere in this disclosure may be included in the examples outlined herein.

In some applications, a multi-component tubular system is provided for accessing a patient's heart. The system may include one or more (e.g., 1, 2, 3, or more) steerable guiding catheters configured to guide a device through them into the heart. The multi-component tubular system may be configured to deliver an implant in a desired orientation to the annulus of a patient's heart valve and facilitate anchoring the implant to the annulus. For some applications, the guiding system may be advanced transcavitarily or transthoracically, or may be able to be advanced transcavitarily or transthoracically to access the atria of the heart. For some applications, the guiding system may be surgically advanced. The system may include two or more steerable catheters. A first catheter has a distal portion steerable to a first desired spatial orientation. A second catheter is disposed within the first catheter and has a distal portion steerable to a second desired spatial orientation. The system provides techniques and relative spatial orientation control means for controlling the orientation of the distal portion of the second catheter relative to the first catheter without substantially deforming the first spatial orientation of the distal portion of the first catheter. For some applications, the relative spatial orientation control means includes a rotational locking mechanism provided by components of the catheter system.

After the first catheter is advanced through the patient's vascular system, the distal portion of the first catheter can be manipulated in a suitable direction. Following the advancement of the first catheter and manipulation of its distal portion in any one or more suitable planes, a second catheter is advanced through the first catheter. Both the first and second catheters can be rotated and locked so that the distal portion of the second catheter can be manipulated relative to the distal portion of the first catheter in any one or more suitable planes in a manner that substantially maintains the spatial orientation of the first catheter during manipulation of the second catheter. Additionally, the first catheter can be further manipulated without substantially disrupting the spatial orientation of the distal portion of the second catheter.

The distal portions and/or distal ends of the first and second catheters can be configured such that, once they have been positioned within the atrium of the patient's heart, an implantable, adjustable annulus remodeling structure (e.g., annulus remodeling ring structure, closed annulus remodeling structure, closed annulus remodeling ring structure, open annulus remodeling structure, partial annulus remodeling ring structure, or other annulus remodeling device) can be deployed, for example, from within the second catheter and anchored to the annulus of the patient's heart valve. The annulus remodeling structure may include a flexible body portion and a constricting member having a first portion extending along the longitudinal length of the body portion. A second portion of the constricting member may extend away from the body portion of the annulus remodeling structure and extend outside the patient's body. From outside the patient's body, a constricting member snare of a constricting member receiving tool is used to snare the proximal distal portion of the constricting member positioned outside the patient's body. Using the snare, the proximal distal portion of the constricting member can then be fed through the distal portion of the main tube of the tool and subsequently through the lumen of a secondary tube of the tool. The constricting member receiving tool can then be advanced along the constricting member toward the patient's annulus. As the tool advances toward the valve ring, the secondary tube of the tool can move distally along the constricting member as it is pulled through the lumen of the tool's secondary tube by the snare.

The retraction member receiving tool may include an ejector movable on a distal end portion of the tool. The ejector is removably coupled to a suture fastener including a clamping structure that can be flexed to an open state through which the retraction member can pass, and the clamping structure is biased toward a closed position or closed state, in which the clamping structure clamps onto the retraction member passing through it. The tool may have at least one stop that holds the suture fastener (e.g., its clamping structure) in its open state.

The snare portion can be configured or adapted to capture the contractile member and pull it proximally through the suture fastener and out of the alignment port in the tool. The tool can then be advanced toward the annulus-forming structure implanted along the annulus. The tool can then receive a continuous portion of the contractile member to contract the annulus-forming structure. Subsequently, the ejector of the tool can be moved, and the suture fastener (e.g., its clamping structure) can be switched from its open state to its closed state to clamp onto the contractile member passing through it.

The tool may include a handle portion that may include a shrinkage member receiving device for receiving a continuous portion of a shrinkage member. The handle portion may include a tension gauge configured to measure the degree of tension of the shrinkage member.

For some applications, the valve annulus forming structure (e.g., valve annulus forming ring structure, closed valve annulus forming structure, open valve annulus forming structure, partial valve annulus forming ring structure, or other valve annulus forming device) includes a body portion that includes a retractable sleeve, a retractable member extending through the retractable sleeve, and a housing that includes fasteners through which the retractable member passes. Once the valve annulus forming structure or valve annulus forming ring structure has retracted, the fasteners are deployed within the housing to retain the retracted valve annulus forming structure or valve annulus forming ring structure.

A shrink-fit member cutting tool is provided, wherein it is possible to cut through the shrink-fit member only when the shrink-fit member has been locked in place by a fastener to which it is attached. The shrink-fit member cutting tool can be constructed in a variety of ways to apply a cutting surface to the shrink-fit member, for example, having a sharp edge that moves toward the shrink-fit member; multiple edges and/or surfaces that move relative to each other, such as a scissor-like motion or a similar wire cutting tool; and so on.

Therefore, according to some applications, a system and/or device is provided that includes an implantable annulus reshaping structure. The annulus reshaping structure includes a main body portion and a retraction member. In some embodiments, the retraction member may have (1) a first portion extending along the longitudinal length of the main body portion of the annulus reshaping structure, and (2) a second portion extending away from the main body portion of the annulus reshaping structure.

The system and/or device may include a retractable member receiving tool. The retractable member receiving tool may include a main tube terminating at a distal end portion of the retractable member receiving tool, the distal end portion having a distal tip, and a secondary tube disposed parallel to the main tube, the secondary tube having a secondary tube lumen configured for the retractable member to pass through. In some embodiments, the retractable member receiving tool further includes a retractable member snare, the retractable member snare including a distal snare portion and an elongated flexible portion coupled to the distal snare portion, the distal snare portion being configured to enclose a portion of the retractable member. The size of the retractable member snare may be set to extend through the secondary tube lumen of the secondary tube to pull a second portion of the retractable member through the length of the secondary tube.

For some applications, the distal snare portion is configured such that the second part of the traction contraction member passes through the distal tip of the contraction member receiving tool and then through the length of the secondary tube.

For some applications, shrink-wrap sleeves include wires containing stainless steel. For some applications, shrink-wrap sleeves include wires with a diameter of 0.2 mm to 0.25 mm.

For some applications, the supervisor and/or deputy supervisor are flexible.

For some applications, the valve annulus forming structure defines a complete valve annulus forming ring structure. For other applications, the valve annulus forming structure defines a partial valve annulus forming ring structure.

For some applications, the secondary tube is shaped to define a longitudinal slit.

For some applications, the shrink-fit member receiving tool includes a handle portion, and a first tube and a second tube are connected to the handle portion.

For some applications, the handle portion includes: a shrink member receiving device configured to receive a continuous portion of the shrink member; and a tension meter configured to measure the degree of tension of the shrink member.

For some applications, the shrinkage member housing is actuable to increase the tension of the shrinkage member.

For some applications, the shrink member receiving device includes a knob coupled to the proximal portion of the shrink member, which is configured to increase the tension of the shrink member by pulling it proximally. For some applications, the knob is fixedly coupled to the proximal portion of the shrink member.

For some applications, the shrinkage member receiving device includes a wheel with grooves configured to engage the shrinkage member with the wheel. For other applications, the grooves are shaped to receive the middle portion of the shrinkage member.

For some applications, the size of the secondary tube lumen is set to maintain the connection between the distal snare section and the contraction member.

For some applications, the snare portion includes a flexible ring, and the secondary tube lumen is configured to cause the ring to collapse around the contraction member when the elongated flexible portion is pulled through the secondary tube lumen. For some applications, the secondary tube lumen has a diameter of 0.5 mm to 1.5 mm.

For some applications, shrink wrapping devices include metal wires.

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

For some applications, the distal snare section is configured to pull the second part of the contraction member across the entire length of the sub-tube.

For some applications, shrink-fit containment tools include:

At least one retractable member fastener disposed within a distal end portion of a retractable member receiving tool, the retractable member fastener comprising: a clamping structure (a) biased toward a closed state, in which the clamping structure is configured to clamp onto a retractable member passing through it, and (b) flexible to an open state through which the retractable member can move; and a stop removably coupled to the retractable member fastener and configured to hold the retractable member fastener in the open state.

For some applications, the at least one shrink member fastener includes at least a first shrink member fastener and a second shrink member fastener, the first shrink member fastener and the second shrink member fastener being disposed within the distal end portion of the shrink member receiving tool.

For some applications, the size of the distal snare portion and the elongated flexible body portion of the shrink member snare are set to pass distally through the shrink member fastener in the open state. The snare portion is adapted to capture the shrink member and pull the shrink member proximally through the shrink member fastener and through the alignment port in the distal end portion of the shrink member receiving tool.

For some applications, the retractable member receiving tool includes a fastener-ejector movable within a distal end portion of the retractable member receiving tool, and the movement of the fastener-ejector contacts the retractable member fastener and changes the retractable member fastener from an open state to a closed state to clamp onto the retractable member passing through it.

For some applications, the fastener-ejector is attached to the stop and is removably attached to the fastener stop.

For some applications, the distal end portion of the retractable member receiving tool is shaped to define a sharp edge, and the retractable member is positioned adjacent to the sharp edge such that the fastener-ejector's movement against the sharp edge cuts through the retractable member of the fastener.

For some applications, the system and/or device also includes:

At least one retractable member fastener configured to surround a retractable member, the retractable member fastener comprising: a clamping structure (a) biased toward a closed state, in which the clamping structure is configured to clamp onto the retractable member passing through it, and (b) flexible to an open state through which the retractable member can move; and a stop removably coupled to the retractable member fastener and configured to hold the retractable member fastener in the open state.

For some applications, the retractable member receiving tool includes a fastener-ejector movable within a distal end portion of the retractable member receiving tool, and the movement of the fastener-ejector is configured to switch the retractable member fastener from an open state to a closed state to clamp onto the retractable member passing through it.

For some applications, the fastener ejector is removably coupled to the stop and the stop is movable and removably coupled to the fastener.

For some applications, the tool includes a movable cutting element with a sharp edge, and the movement of a stop against the movable cutting element hammers the stop, causing the moving cutting extension of the movable cutting element to pass through the fastener and through the contraction member of the movable cutting element.

For some applications, the system and/or device also includes a lock that can slide along the contraction member, the lock being securely coupled to the contraction member to prevent movement of the contraction member. The lock may be shaped to define a slit extending from a proximal surface of the lock toward a distal surface of the lock. The lock may define a lock cavity extending from a proximal opening in the lock toward a distal opening in the lock. The lock cavity may be configured to surround the contraction member. In some applications, when the lock is compressed, the slit allows the lock to close around the contraction member, thereby locking the lock to the contraction member.

For some applications, the valve ring forming structure is shaped to define a recess, the size of which is set to compress the lock when the lock is at least partially disposed within the recess.

For some applications, the size of the recess is set such that the lock compresses when it is at least partially located within the recess.

For some applications, the lock cavity is shaped to define a distal portion that is wider than the proximal portion of the lock cavity.

For some applications, the recess is shaped to define a proximal portion that is narrower than any other portion of the recess that is away from the proximal portion.

For some applications, the lock is located within the distal end portion of the retractable member receiving tool.

In some applications, when the shrink member receiving tool is attached to the valve ring forming structure, the lock is at least partially located within the recess.

In some applications, when the shrink member receiving tool is attached to the valve ring forming structure, the lock is located entirely on the proximal side of the recess.

For some applications, the lock is located within the distal end portion of the retractable member receiving tool.

For some applications, the size of the distal snare portion and the elongated flexible body portion of the retractable member snare are set to pass through the lock distally. The snare portion is adapted to capture the retractable member and pull the retractable member through the lock and through the alignment port in the distal end portion of the retractable member receiving tool proximally.

According to some applications, a system and/or device is further provided, which includes an implantable annulus reshaping structure. The implantable annulus reshaping structure includes a body portion and a retraction member. The retraction member may have (1) a first portion extending along the longitudinal length of the body portion of the annulus reshaping structure, and (2) a second portion extending away from the body portion of the annulus reshaping structure.

The system and/or device may also include a housing configured to be positioned against the main body portion of the lobed ring structure.

The system and/or device may also include a retractable member fastener at least partially disposed within the housing, the retractable member fastener including a clamping structure that (a) is biased toward presenting a closed state, in which the clamping structure is configured to clamp onto the retractable member passing through it, and (b) can be flexed to an open state through which the retractable member can move.

The system and/or device may further include: a stop removably coupled to a fastener and configured to hold the retractable member fastener in an open state; and a fastener-ejector engaging with the stop such that movement of the fastener-ejector moves the stop removably coupled to the fastener and converts the clamping structure from an open state to a closed state to clamp onto the retractable member passing through it.

For some applications, fastener ejectors are shaped to allow their movement to facilitate cutting off retractable members that extend through the fastener.

For some applications, the fastener includes a deformable element having a tilted state and a straight state, a stop is configured to hold the fastener in the tilted state, and when the stop is removed, the fastener is configured to transition to the straight state and cause the contraction member to be located between the surfaces of the fastener and the housing.

For some applications, fasteners are shaped to define multiple teeth, which are configured to increase friction between the contraction member and the fastener.

According to some applications, a method is also provided that includes advancing an implantable annulus remodeling structure toward a patient's heart, the implantable annulus remodeling structure including a main body portion and a constricting member. The constricting member is the same as or similar to other constricting members described herein and may have (1) a first portion extending along the longitudinal length of the main body portion of the annulus remodeling structure, and (2) a second portion extending away from the main body portion of the annulus remodeling structure.

The method further includes guiding a second portion of the retractable member through a retractable member receiving tool. The retractable member receiving tool may include a main tube terminating at a distal end portion having a distal tip, and a secondary tube disposed alongside the main tube having a secondary tube lumen configured for the retractable member to pass through. The retractable member receiving tool may also include a retractable member snare comprising a distal snare portion and an elongated flexible portion coupled to the distal snare portion, the distal snare portion being configured to enclose a portion of the retractable member and sized to pass through the secondary tube lumen of the secondary tube to pull the second portion of the retractable member through the length of the secondary tube.

For some applications, threading includes using the distal snare portion to encircle the portion of the contraction member; using the contraction member snare to pull the portion of the contraction member through the sub-tube; and after threading, advancing the contraction member receiving tool along the contraction member toward the valve ring forming structure.

For some applications, threading the second part of the retractable member includes threading the second part of the retractable member after the advance.

For some applications, a portion of the tension-shrink member passes through the sub-tube, including a second portion of the tension-shrink member passing through the distal tip of the shrink member receiving tool and subsequently through the length of the sub-tube.

For some applications, the portion of the tension contraction member that passes through the sub-tube includes a connection between the tension contraction member and the snare portion.

For some applications, the method also includes using the shrinking member receiving tool to shrink the valve ring forming structure after advancing the shrinking member receiving tool.

For some applications, the shrinkage member receiving tool shrinkage valve ring forming structure includes a continuous portion that advances the shrinkage member relative to the shrinkage member receiving device.

For some applications, the method also includes holding the valve ring forming structure in the contracted state after contraction by clamping fasteners around a portion of the contraction member.

For some applications, clamping involves deploying fasteners from within the distal end portion of the shrink member receiving tool.

For some applications, the method also includes cutting the shrinking member with the sharp edge of the shrinking member receiving tool after holding the valve ring forming structure in the shrinking state.

For some applications, the propulsion contraction member containment tool includes the propulsion contraction member containment tool through the patient's vascular system.

For some applications, the shrink member receiving tool includes a handle portion comprising: a shrink member receiving device configured to receive a continuous portion of the shrink member; and a tension meter configured to measure the degree of tension of the shrink member.

For some applications, the method also includes using a shrink member containment device to increase the tension of the shrink member.

For some applications, the shrinkage member receiving device includes a wheel and has grooves, and the method also includes attaching the shrinkage member to the wheel.

For some applications, attaching the shrinkage member to the wheel includes attaching the middle portion of the shrinkage member to the wheel.

This method can be performed in procedures on live animals or in simulation/simulation procedures (e.g., on cadavers, cadaver hearts, simulators with simulated hearts, tissues, etc., anthropomorphic ghosts, etc.).

According to some applications, a method is also provided, which includes advancing an implantable annulus remodeling structure toward a patient's heart. The implantable annulus remodeling structure may be the same as or similar to other annulus remodeling structures known herein or otherwise, and may include, for example, a body portion, a constricting member, and a housing coupled to the body portion of the annulus remodeling structure. For some applications, the constricting member has (1) a first portion extending along the longitudinal length of the body portion of the annulus remodeling structure, and (2) a second portion extending away from the body portion of the annulus remodeling structure.

For some applications, the retractable member fastener is disposed within the housing and includes a clamping structure that (a) is biased toward a closed state, in which the clamping structure is configured to clamp onto the retractable member passing through it, and (b) can be flexed to an open state through which the retractable member can move. For some applications, a stop is removably coupled to the fastener and configured to hold the retractable member fastener in the open state.

For some applications, the method also includes moving a fastener-ejector that engages with a stop, such that the movement of the fastener-ejector causes the stop, which is removably coupled to the fastener, to move, thereby changing the retractable member fastener from an open state to a closed state so as to clamp onto the retractable member passing through it.

For some applications, the method also includes, after advancement, using a shrinking member to shrink the valve ring forming structure and converting the shrinking member fastener from an open state to a closed state, including the conversion after shrinkage.

For some applications, the shrinking valve ring forming structure includes a shrinking valve ring forming structure using a shrinking member receiving tool.

For some applications, the shrinkage member receiving tool shrinkage valve ring forming structure includes a continuous portion that advances the shrinkage member relative to the shrinkage member receiving device.

For some applications, the method also includes cutting the shrink member with the sharp edge of the shrink member receiving tool after the shrink member fastener has been switched from the open state to the closed state.

This method can be performed in procedures on live animals or in simulation/simulation procedures (e.g., on cadavers, cadaver hearts, simulators with simulated hearts, tissues, etc., anthropomorphic mannequins, etc.).

According to some applications, a system is also provided that includes an implantable annulus remodeling structure comprising a body portion and a retraction member extending at least partially along the longitudinal length of the body portion of the annulus remodeling structure. The system also includes a retraction member receiving tool. The retraction member receiving tool may include a tube having a lumen and a retraction member snare configured to allow the retraction member to pass through. The retraction member snare may include a distal snare portion and an elongated flexible portion coupled to the distal snare portion, the distal snare portion being configured to encircle a portion of the retraction member and pull it into the lumen.

For some applications, the distal snare portion is configured to pull the contractile member through the entire length of the lumen.

For some applications, the shrink-fit sleeve includes wire containing stainless steel. For others, the tubing is flexible.

For some applications, the shrink-fit member receiving tool includes a handle portion, and a tube is connected to the handle portion.

For some applications, the handle portion includes: a shrink member receiving device configured to receive a continuous portion of the shrink member; and a tension meter configured to measure the degree of tension of the shrink member.

For some applications, the shrinkage member housing is actuable to increase the tension of the shrinkage member.

For some applications, the shrinkage member receiving device includes a wheel with grooves configured to engage the shrinkage member to the wheel.

For some applications, the groove is shaped to receive the middle section of the shrinkage member.

For some applications, the size of the tube lumen is set to maintain the connection between the distal snare section and the contraction member.

For some applications, the distal snare portion includes a flexible ring, and the lumen is configured such that the ring collapses around the contraction member as this portion of the contraction member is pulled through the lumen.

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

In some applications, the distal end portion of the shrink member receiving tool is shaped to define a sharp edge, and the shrink member receiving tool is configured to position the shrink member adjacent to the sharp edge, such that the sharp edge can cut off the shrink member.

For some applications, shrink-fit containment tools include:

A retractable member fastener disposed within a distal end portion of a retractable member receiving tool, the retractable member fastener comprising a clamping structure, the clamping structure being (a) biased toward a closed state, in which the clamping structure is configured to clamp onto a retractable member passing through it, and (b) flexible to an open state through which the retractable member can move; and

A stop member is removably coupled to a shrink member fastener and is configured to hold the shrink member fastener in the open position.

For some applications, the size of the distal snare portion and the portion of the retractable member snare is set to pass distally through the retractable member fastener in its open state. The distal snare portion is adapted to capture the portion of the retractable member and pull it proximally through the retractable member fastener and through the alignment port in the distal end portion of the retractable member receiving tool.

For some applications, the retractable member receiving tool includes a fastener-ejector movable within a distal end portion of the retractable member receiving tool, and the movement of the fastener-ejector contacts the retractable member fastener and can switch the retractable member fastener from its open state to its closed state to clamp it onto the retractable member as it passes through.

For some applications, the fastener-ejector is attached to the stop and is removably attached to the fastener stop.

For some applications, the distal end portion of the retractable member receiving tool is shaped to define a sharp edge, and the retractable member receiving tool is configured to position the retractable member adjacent to the sharp edge, such that the movement of the fastener-ejector against the sharp edge cuts off the retractable member after it extends through the fastener.

For some applications, implantable annulusoplasty structures are closed annulusoplasty structures.

According to some applications, a system and/or device is also provided, which includes an implantable annulus shaping structure comprising a body portion having sidewalls and a constriction member. In some applications, the constriction member has (1) a first portion extending along the longitudinal length of the body portion of the annulus shaping structure, and (2) a second portion extending away from the body portion of the annulus shaping structure, the constriction member being configured to adjust the periphery of the annulus shaping structure.

The main body of the valve annulus forming structure can be shaped to define a recess having a recess axis extending from an opening in a first surface of the sidewall of the main body toward an opposite second surface of the sidewall of the main body, the sidewall of the main body extending away from the recess along a longitudinal axis at a non-zero angle relative to the recess axis, and a contraction member extending through the recess and via the recess away from the main body of the valve annulus forming structure.

The system and/or device may include a lock that is slidable along the contraction member and toward the recess, the lock being securely coupled to the contraction member to prevent movement of the contraction member, the recess being shaped to facilitate a secure coupling to the contraction member.

For some applications, the lock can be at least partially located within a recess.

For some applications, the valve annulus forming structure includes a complete valve annulus forming ring structure; in other cases, the valve annulus forming structure includes a partial valve annulus forming ring structure.

For some applications, the lock is configured to lock the retractable member when the lock moves at least partially within the recess.

For some applications, the lock is constructed to fit perfectly within the recess.

For some applications, the main body includes a housing, which defines at least a portion of the sidewalls and a recess.

For some applications, the lock is shaped to define a lock thread portion, and the valve ring forming structure is shaped to define a valve ring forming structure thread portion, which is configured to engage with the lock thread portion.

For some applications, the recess defines a recessed lumen extending along the recessed axis. For some applications, the recessed axis is set at a non-zero angle.

For some applications, 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 defining a lock cavity extending from a proximal opening in the lock toward a distal opening in the lock, the lock cavity being configured to surround a contraction member, and when the lock is positioned within the recess, the slit allows the lock to close around the contraction member and thus lock the lock to the contraction member.

For some applications, the size of the recess is set such that the lock compresses when it is at least partially located within the recess.

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

For some applications, the lock cavity is shaped to define a distal portion that is wider than the proximal portion of the lock cavity.

For some applications, the recess is shaped to define a nearest side portion that is narrower than any other portion of the recess that is away from the nearest side portion.

For some applications, the valve ring forming structure includes a housing, and the housing is formed to define a recess having a recess axis.

For some applications, the lock is shaped to define a locking thread portion, and the housing is shaped to define a valve ring shaped thread portion that is configured to engage with the locking thread portion.

For some applications, the housing is shaped to define a shrinkage member cavity, which is set at a non-zero angle relative to the axis of the recess.

For some applications, the housing is shaped to provide a shrinkage member cavity wall disposed along the shrinkage member cavity, and when the lock is disposed in the recess, the distal end of the lock is configured to press a first portion of the shrinkage member against the shrinkage member cavity wall in order to lock the shrinkage member at at least a first compression point.

For some applications, the recess is shaped to define a distal tapering portion of the recess. For some applications, the lock is shaped to define a lock cavity and a distal tapering portion of the lock, the lock cavity extending from a proximal opening in the lock toward a distal opening in the lock. The lock cavity may be configured to surround a contracting member.

In some applications, when the lock is located in the recess, the distal tapered portion of the recess is configured to compress the distal tapered portion of the lock, which is then configured to press a second portion of the retractable member into the lock cavity at the distal tapered portion of the recess, so as to lock the retractable member at at least the second compression point.

For some applications, the system and/or device also includes a delivery tool that slides relative to the contractile member, the delivery tool being configured to deliver the annulus-forming structure to the valve annulus of the patient's heart.

For some applications, the delivery tool includes a knob attached to the proximal portion of the shrink member, which is configured to increase the tension of the shrink member by pulling it proximal.

In some applications, the knob is fixedly connected to the proximal part of the retractable component.

In some applications, when the delivery tool is attached to the valve ring forming structure, a portion of the shrinkage member is disposed within the lumen of the delivery tool, and a lock surrounds a portion of the shrinkage member.

For some applications, when the delivery tool is attached to the lobed ring forming structure, the lock is at least partially located within the recess.

For some applications, when the delivery tool is attached to the lobed annulus forming structure, the lock is positioned entirely on the proximal side of the recess.

For some applications, the delivery tool includes a lock-ejector movable within a distal end portion of the delivery tool, and the movement of the lock-ejector contacts the lock and changes the lock from an open state to a closed state to clamp onto a retractable member passing through it.

For some applications, the distal end portion of the delivery tool is shaped to define a sharp edge, and a retractable member is positioned adjacent to the sharp edge such that the movement of the lock ejector against the sharp edge cuts through the retractable member of the lock.

According to some applications, a system and/or device is also provided, comprising an implantable annulus shaping structure including a body portion and a retraction member. The retraction member may be the same as or similar to other retraction members described herein and may, for example, have (1) a first portion extending along a longitudinal length of the body portion of the annulus shaping structure, and (2) a second portion extending away from the body portion of the annulus shaping structure. The system and/or device may include a lock slidable along the retraction member, the lock being securely coupled to the retraction member to prevent movement of the retraction member. The lock may be shaped to define a slit extending from a proximal surface of the lock toward a distal surface of the lock.

For some applications, the lock defines a cavity extending from a proximal opening in the lock toward a distal opening in the lock. The cavity can be configured to surround a contraction member. When the lock is compressed, the slit allows the lock to close around the contraction member, thereby locking the lock against the contraction member.

For some applications, the valve annulus forming structure includes a complete valve annulus forming ring structure; in other cases, the valve annulus forming structure includes a partial valve annulus forming ring structure.

For some applications, the valve ring forming structure is shaped to define a recess, the size of which is set to compress the lock when the lock is at least partially disposed within the recess.

For some applications, the lock can be at least partially located within a recess.

For some applications, the lock is constructed to fit perfectly within the recess.

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

For some applications, the lock cavity is shaped to define a distal portion that is wider than the proximal portion of the lock cavity.

For some applications, the recess is shaped to define a proximal portion that is narrower than any other portion of the recess that is away from the proximal portion.

For some applications, the lock is shaped to define a lock thread portion, and the valve ring forming structure is shaped to define a valve ring forming structure thread portion, which is configured to engage with the lock thread portion.

For some applications, the valve ring forming structure includes a housing, and the housing is formed to define a recess having a recess axis.

For some applications, the lock is shaped to define a locking thread portion, and the housing is shaped to define a valve ring shaped thread portion that is configured to engage with the locking thread portion.

For some applications, the housing is shaped to define a shrinkage member cavity, which is set at a non-zero angle relative to the axis of the recess.

For some applications, the housing is shaped to provide a shrinkage member cavity wall disposed along the shrinkage member cavity, and when the lock is disposed in the recess, the distal end of the lock is configured to press a first portion of the shrinkage member against the shrinkage member cavity wall in order to lock the shrinkage member at at least a first compression point.

For some applications, the recess is shaped to define a distal tapering portion of the recess, and the lock is shaped to define a lock cavity and a distal tapering portion of the lock, the lock cavity extending from a proximal opening in the lock toward a distal opening in the lock. The lock cavity can be configured to surround a contraction member. When the lock is positioned within the recess, the distal tapering portion of the recess can be configured to compress the distal tapering portion of the lock, which is then configured to press a second portion of the contraction member into the lock cavity at the distal tapering portion of the recess, thereby locking the contraction member at at least a second compression point.

For some applications, the system and/or device also includes a delivery tool that slides relative to the contractile member, the delivery tool being configured to deliver the annulus-forming structure to the valve annulus of the patient's heart.

For some applications, the delivery tool includes a knob attached to the proximal portion of the shrink member, which is configured to increase the tension of the shrink member by pulling it proximal.

In some applications, the knob is fixedly connected to the proximal part of the retractable component.

In some applications, when the delivery tool is attached to the valve ring forming structure, a portion of the shrinkage member is disposed within the lumen of the delivery tool, and a lock surrounds a portion of the shrinkage member.

For some applications, the valve ring forming structure is shaped to define a recess, the size of which is set such that when the lock is at least partially disposed within the recess, the lock is compressed, and when the delivery tool is engaged with the valve ring forming structure, the lock is at least partially disposed within the recess.

For some applications, the valve ring forming structure is shaped to define a recess, the size of which is set such that when the lock is at least partially disposed within the recess, the lock is compressed, and when the delivery tool is engaged with the valve ring forming structure, the lock is fully disposed near the recess.

For some applications, the delivery tool includes a lock-ejector movable within a distal end portion of the delivery tool, and the movement of the lock-ejector contacts the lock and changes the lock from an open state to a closed state to clamp onto a retractable member passing through it.

For some applications, the distal end portion of the delivery tool is shaped to define a sharp edge, and a retractable member is positioned adjacent to the sharp edge such that the movement of the lock ejector against the sharp edge cuts through the retractable member of the lock.

According to some applications, a method is also provided that includes advancing an implantable annulus remodeling structure toward a patient's heart. The implantable annulus remodeling structure may be the same as or similar to other annulus remodeling structures known herein or otherwise, for example, having a body portion and a constricting member having sidewalls, the constricting member having (1) a first portion extending along the longitudinal length of the body portion of the annulus remodeling structure, and (2) a second portion extending away from the body portion of the annulus remodeling structure, the constricting member being configured to adjust the periphery of the annulus remodeling structure.

The main body of the annular forming structure can be formed to define a recess having a recess axis, the recess extending from an opening in a first surface of the sidewall of the main body toward an opposing second surface of the sidewall of the main body, the sidewall of the main body extending away from the recess along a longitudinal axis at a non-zero angle relative to the recess axis, and a contraction member extending through the recess and via the recess away from the main body of the annular forming structure;

The method may also include locking the retractable member by sliding a lock along the retractable member to engage within a recess, the lock being fixedly coupled to the retractable member to prevent movement of the retractable member, the recess being shaped to facilitate a fixed engagement with the retractable member.

For some applications, the advancement includes advancing the valve ring forming structure when the lock is at least partially located within the recess.

For some applications, the advancement includes advancing the valve ring forming structure when the lock is fully positioned on the proximal side of the recess.

For some applications, the locking retraction member includes sliding the lock completely into the recess.

For some applications, the valve annulus forming structure includes a complete valve annulus forming ring structure or a partial valve annulus forming ring structure.

For some applications, 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 defining a lock cavity extending from a proximal opening in the lock toward a distal opening in the lock, the lock cavity being configured to surround a contraction member, and when the lock is positioned within the recess, the slit allows the lock to close around the contraction member and thus lock the lock to the contraction member.

For some applications, the size of the recess is set such that the lock is compressed when it is at least partially positioned within the recess, and locking includes positioning the lock at least partially within the recess to compress the lock.

For some applications, the lock cavity is shaped to define a distal portion that is wider than the proximal portion of the lock cavity.

For some applications, the recess is shaped to define a proximal portion that is narrower than any other portion of the recess that is away from the proximal portion.

For some applications, propulsion involves using a delivery tool to advance the valve ring forming structure, and the method also includes sliding the delivery tool and the contraction member relative to each other.

For some applications, propulsion includes advancing the lock within the delivery tool, and locking includes sliding the lock using the delivery tool.

For some applications, the delivery tool includes a knob attached to the proximal portion of the shrink member, and the method also includes using the knob to increase the tension of the shrink member by pulling it proximal.

In some applications, the knob is fixedly connected to the proximal part of the retractable component.

For some applications, the delivery tool includes a lock ejector movable within a distal end portion of the delivery tool, and the method further includes clamping the lock onto a retractable member passing through it by moving the lock ejector to contact the lock and change the lock from an open state to a closed state.

For some applications, the distal end portion of the delivery tool is shaped to define a sharp edge, and the retractable member is positioned adjacent to the sharp edge. Moving the lock ejector includes moving the lock ejector against the sharp edge and cutting off the retractable member extending through the lock by moving the lock ejector against the sharp edge.

This method can be performed in procedures on live animals or in simulation/simulation procedures (e.g., on cadavers, cadaver hearts, simulators with simulated hearts, tissues, etc., anthropomorphic mannequins, etc.).

According to some applications, a method is also provided that includes advancing an implantable annulus remodeling structure toward a patient's heart. The annulus remodeling structure may be the same as or similar to other annulus remodeling structures known herein or otherwise, and may include, for example, a body portion having sidewalls and a constricting member. The constricting member may have (1) a first portion extending along the longitudinal length of the body portion of the annulus remodeling structure, and (2) a second portion extending away from the body portion of the annulus remodeling structure, the constricting member being configured to adjust the periphery of the annulus remodeling structure.

The method also includes locking the contraction member by sliding a lock along the contraction member, the lock being securely engaged with the contraction member to prevent movement of the contraction member. The lock can be shaped to define a slit extending from a proximal surface of the lock toward a distal surface of the lock. The lock can define a lock cavity extending from a proximal opening in the lock toward a distal opening in the lock. The lock cavity can be configured to surround the contraction member. For some applications, when the lock is compressed, the slit allows the lock to close around the contraction member, thereby locking the lock to the contraction member.

For some applications, the valve annulus forming structure includes a complete valve annulus forming ring structure or a partial valve annulus forming ring structure.

For some applications, the valve ring forming structure is shaped to define a recess, the size of which is set to compress the lock when the lock is at least partially disposed within the recess, and the locking retraction member includes a sliding lock at least partially disposed within the recess.

For some applications, the advancement includes advancing the valve ring forming structure when the lock is at least partially located within the recess.

For some applications, the advancement includes advancing the valve ring forming structure when the lock is fully positioned on the proximal side of the recess.

For some applications, the locking retraction member includes sliding the lock completely into the recess.

For some applications, the size of the recess is set such that the lock compresses when it is at least partially located within the recess.

For some applications, the lock cavity is shaped to define a distal portion that is wider than the proximal portion of the lock cavity.

For some applications, the recess is shaped to define a proximal portion that is narrower than any other portion of the recess that is away from the proximal portion.

For some applications, propulsion involves using a delivery tool to advance the valve ring forming structure, and the method also includes sliding the delivery tool and the contraction member relative to each other.

For some applications, propulsion includes advancing the lock within the delivery tool, and locking includes sliding the lock using the delivery tool.

For some applications, the delivery tool includes a knob attached to the proximal portion of the shrink member, and the method also includes using the knob to increase the tension of the shrink member by pulling it proximal.

In some applications, the knob is fixedly connected to the proximal part of the retractable component.

For some applications, the delivery tool includes a lock ejector movable within a distal end portion of the delivery tool, and the method further includes clamping the lock onto a retractable member passing through it by moving the lock ejector to contact the lock and change the lock from an open state to a closed state.

For some applications, the distal end portion of the delivery tool is shaped to define a sharp edge, and the retractable member is positioned adjacent to the sharp edge. Moving the lock ejector includes moving the lock ejector against the sharp edge and cutting off the retractable member extending through the lock by moving the lock ejector against the sharp edge.

This method can be performed in procedures on live animals or in simulation/simulation procedures (e.g., on cadavers, cadaver hearts, simulators with simulated hearts, tissues, etc., anthropomorphic mannequins, etc.).

According to some applications, a system and/or device is also provided, which includes an implantable annulus shaping structure comprising a main body portion and a retraction member. The retraction member may be the same as or similar to other retraction members known herein or otherwise, and may, for example, have (1) a first portion extending along the longitudinal length of the main body portion of the annulus shaping structure, and (2) a second portion extending away from the main body portion of the annulus shaping structure.

The system and/or device further includes at least one shrink member fastener configured to surround a shrink member, the shrink member fastener including a clamping structure that (a) is biased toward presenting a closed state, in which the clamping structure is configured to clamp onto the shrink member passing through it, and (b) can be flexed to an open state through which the shrink member can move.

The system and/or device further includes a stop and a shrink member cutting tool, the stop being removably coupled to a shrink member fastener and configured to hold the shrink member fastener in an open position. The shrink member cutting tool may include a static cutting element having a first cutting surface, a dynamic cutting element having a second cutting surface opposite to the first cutting surface, and one or more grippers configured to pull the stop proximally and remove it from the shrink member fastener. In some applications, a portion of the shrink member passes through the static cutting element and through the dynamic cutting element, and once pulled proximally, the stop contacts the cutting element and is configured to push against the dynamic cutting element and move the dynamic cutting element relative to the static cutting element to cut the shrink member.

In some applications, the first and second cutting surfaces are each concave. In other applications, the first and second cutting surfaces are each diagonal.

For some applications, the tool is arranged to provide a safety mechanism, so that the movement of the dynamic cutting element relative to the static cutting element is only possible when the stop is pushed against the dynamic cutting element.

For some applications, the system and/or device also includes a housing that accommodates fasteners and stops, and the tool is coupled to the housing when the gripper grips the stops.

For some applications, the tool is configured to deliver the housing, fasteners, and stops to the implantable valve annulus molding structure.

For some applications, implantable annulus remodeling structures include a housing.

In some applications, the stop is shaped to define the overhang, and the gripper is configured to grip the overhang in order to initially attach the tool to the fastener.

For some applications, the system and/or device also includes an outer sleeve portion configured to surround the gripper so as to lock the gripper relative to the overhang.

According to some applications, a system and/or device is also provided, comprising a shrinkage member fastener configured to be fastened to a shrinkage member. For some applications, at least one shrinkage member fastener is configured to surround the shrinkage member. The shrinkage member fastener may include a clamping structure that (a) is biased toward presenting a closed state, in which the clamping structure is configured to clamp onto the shrinkage member passing through it, and (b) can be flexed to an open state through which the shrinkage member can move.

The system and/or device may include a stop that is removably coupled to a shrink member fastener and configured to hold the shrink member fastener in the open position.

The system and/or device may include a shrinkage member cutting tool. The shrinkage member cutting tool may include a cutting element configured to cut the shrinkage member and one or more grippers configured to pull a stop proximally and remove the stop from the shrinkage member fastener. In some applications, once pulled proximally, the stop contacts the cutting element and is configured to push against and move the cutting element to facilitate cutting the shrinkage member through the cutting element.

For some applications, the tool is arranged to provide a safety mechanism, so that movement of the cutting element is only possible when the stop is pushed against the cutting element.

For some applications, the system and/or device also includes a housing that accommodates fasteners and stops, and the tool is coupled to the housing when the gripper grips the stops.

For some applications, the system and/or device also includes an implantable annulus shaping structure, the tool being configured to deliver the housing, fasteners, and stops to the implantable annulus shaping structure.

For some applications, the system and/or device also includes an implantable annulus shaping structure, which includes a housing.

In some applications, the stop is shaped to define the overhang, and the gripper is configured to grip the overhang in order to initially attach the tool to the fastener.

For some applications, the system and/or device also includes an outer sleeve portion configured to surround the gripper so as to lock the gripper relative to the overhang.

According to some applications, a method is also provided that includes threading a shrinkage member cutting tool along a shrinkage member, the shrinkage member cutting tool including a cutting element adjacent to the shrinkage member during threading. The method may further include engaging the tool with a stop removably coupled to a shrinkage member fastener surrounding a portion of the shrinkage member, the stop being configured to hold the shrinkage member fastener in an open state.

For some applications, the method also includes using a tool to pull the stop to disengage it from the shrinkage member fastener, and to bring the stop into contact with the cutting element by pulling, thereby facilitating the pushing of the stop against the cutting element and facilitating the movement of the cutting element, and thus facilitating the cutting of the shrinkage member by the cutting element.

For some applications, the tool is arranged to provide a safety mechanism, so that movement of the cutting element is only possible by pushing a stop against the cutting element.

For some applications, the method also includes a housing that accommodates fasteners and stops, and the method includes attaching a tool to the housing by gripping the stops with a tool.

For some applications, the method also includes using the tool to deliver the housing, fasteners, and stops to the implantable valve annulus molding structure.

For some applications, attaching the tool to the housing includes attaching the tool to the housing that is connected to the implantable annulus shaping structure.

For some applications, the stop is shaped to define a cantilever, and engaging the tool with the stop involves initially attaching the tool to the fastener by gripping the cantilever with a tool having a gripper.

For some applications, the method also includes locking the gripper relative to the overhang by fitting the outer sleeve portion over the gripper.

This method can be performed in procedures on live animals or in simulation/simulation procedures (e.g., on cadavers, cadaver hearts, simulators with simulated hearts, tissues, etc., anthropomorphic mannequins, etc.).

According to some applications, a system and/or device is also provided, comprising: an implant including an implantable structure and a flexible, elongated retractable member extending away from the implantable structure; and a retractable member receiving tool including a handle portion including an outer housing, a tubular shaft at least partially disposed within the outer housing, and an inner shaft.

For some applications, the inner shaft (a) is partially disposed within the proximal longitudinal portion of the tubular shaft such that the inner shaft can slide axially relative to the tubular shaft, (b) is shaped to define an inner shaft retractor receiving channel, and (c) includes a lock configured to (i) allow the retractor to slide relative to the inner shaft retractor receiving channel when in an unlocked state, and (ii) lock the retractor axially relative to the inner shaft when in a locked state.

For some applications, the system and/or device (e.g., in the handle) also includes a distal force applicator (a) which is at least partially disposed within the distal longitudinal portion of the tubular shaft, and (b) which is shaped to define a distal force applicator retraction member receiving channel that allows the retraction member to slide through it.

For some applications, the system and/or device (e.g., in the handle) also includes: a spring disposed within the tubular shaft, connecting the distal force applicator and the distal portion of the inner shaft; and a contraction-promoting knob accessible from the outside of the outer housing.

For some applications, the handle portion is shaped to define a handle retraction member receiving channel extending from the distal end of the handle portion to the proximal end, the handle retraction member receiving channel including an inner shaft retraction member receiving channel and a distal force applicator retraction member receiving channel.

For some applications, the handle portion is configured such that when the retractable member is set to pass fully through the handle retractable member receiving channel and the lock is in the locked state, actuation of the retractable facilitator knob receives a continuous portion of the retractable member by advancing the tubular shaft proximally relative to the outer housing. This advances the distal force applicator proximally relative to the outer housing, which applies a proximally guiding force to the spring. This pushes the inner shaft proximally relative to the outer housing, and this pulls the retractable member proximally.

For some applications, the handle portion is configured such that when the retraction member is set to pass completely through the handle retraction member receiving channel, actuating the retraction actuation knob results in a locked state and the retraction member being tensioned: the spring pushes the inner shaft proximally relative to the outer housing to a lesser extent than the tubular shaft pushes proximally relative to the outer housing, and the inner shaft pulls the retraction member proximally, increasing the tension in the retraction member.

For some applications, the contraction-promoting knob is configured to be actuated by its rotation.

In some applications, the tubular shaft and the contraction-promoting knob are threaded together, and the shank portion is configured such that actuation of the contraction-promoting knob rotates the tubular shaft, thereby advancing the tubular shaft proximally relative to the outer housing.

For some applications, the inner shaft protrudes partially beyond the proximal end of the outer housing, and the tubular shaft and the inner shaft together provide a non-electromechanical force gauge, wherein the relative axial position of the tubular shaft relative to the inner shaft provides a visual indication of the measure of tension in the contraction member.

For some applications, the inner shaft is marked with multiple fiduciary markers arranged along the inner shaft to indicate the relative axial position of the tubular shaft with respect to the inner shaft.

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

For some applications, the tension limiting locking assembly is configured to axially lock the inner shaft relative to the outer housing when the tubular shaft is positioned at a predetermined relative axial position relative to the inner shaft, thereby limiting the maximum tension that the inner shaft can apply to the contraction member.

For some applications, the tension limiting locking assembly includes a pawl arranged to axially lock the inner shaft relative to the outer housing when the tubular shaft is positioned at a predetermined relative axial position relative to the inner shaft, thereby limiting the maximum tension that the inner shaft can apply to the contraction member.

For some applications, the pawl is axially fixed to the inner shaft and is configured to move radially outward to engage the outer housing in order to lock the inner shaft axially relative to the outer housing.

For some applications, the tension limiting locking assembly also includes multiple indentations, with the outer housing shaped to define the multiple indentations, a pawl capable of engaging these indentations to axially lock the inner shaft relative to the outer housing, and a shank portion arranged such that when the tubular shaft is positioned relative to the inner shaft in a predetermined relative axial position, a particular indentation engaging the pawl depends on the relative axial position of the inner shaft relative to the outer housing.

For some applications, the proximal longitudinal portion of the tubular shaft is shaped to define an elongated opening through which the pawl passes when the inner shaft is axially locked relative to the outer housing.

For some applications, the tubular shaft includes one or more tracks that extend side-by-side with a longitudinal portion of an elongated opening and are arranged as follows:

(a) When the tubular shaft is positioned distally relative to the inner shaft in a predetermined relative axial position, the pawl is prevented from axially locking the inner shaft relative to the outer housing, and

(b) When the tubular shaft is set in a predetermined relative axial position relative to the inner shaft, the pawl is allowed to lock the inner shaft axially.

For some applications, the one or more tracks are shaped to define one or more corresponding ramp portions such that after the pawl axially locks the inner shaft relative to the outer housing when the tubular shaft is set in a predetermined relative axial position relative to the inner shaft, subsequent distal movement of the tubular shaft and thus distal movement of the one or more tracks relative to the inner shaft disengages the pawl from the outer housing.

For some applications, the inner shaft protrudes partially beyond the proximal end of the outer housing, and the tubular shaft and the inner shaft together provide a non-electromechanical force gauge, wherein the relative axial position of the tubular shaft relative to the inner shaft provides a visual indication of the measure of tension in the contraction member.

For some applications, implantable structures include implantable annulusoplasty structures.

For some applications, implantable annulus remodeling structures include flexible sheaths, and constriction members extend along the sheaths and extend away from the sheaths.

According to some applications, a system and/or device is also provided, comprising: an implant including an implantable structure and a flexible, elongated retractable member extending away from the implantable structure; and a retractable member receiving tool. The retractable member receiving tool may include a handle portion (a) shaped to define a handle retractable member receiving channel extending from a distal end of the handle portion to a proximal end, and (b) including: an outer housing; a non-electromechanical force gauge; a lock; and a retraction actuation knob accessible from the outside of the outer housing. The lock may be configured to (i) allow the retractable member to slide relative to the force gauge when in an unlocked state, and (ii) axially lock the retractable member relative to an axially movable portion of the force gauge, which is axially movable relative to the outer housing, when in a locked state.

For some applications, the handle portion is configured such that when the retractable member is set to pass fully through the handle retractable member receiving channel and the lock is in the locked state, actuation of the retraction actuation knob causes the handle portion to receive a continuous portion of the retractable member by advancing the force gauge proximally relative to the outer housing in order to pull the retractable member proximally.

For some applications, the handle portion is configured such that when the retraction member is actuated with the retraction actuation knob when the retraction member is set to pass completely through the handle retraction member receiving channel, the lock is in a locked state, and the retraction member is tensioned. The tension in the retraction member is increased by the axially movable portion of the force gauge pulling the retraction member proximally, and the force gauge is configured to provide a visual indication of the measure of the tension in the retraction member.

For some applications, force gauges include springs.

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

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

According to some applications, a method is also provided, comprising: 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 guiding a portion of the contractile member through a handle contractile member receiving channel of a handle portion of a contractile member receiving tool. The contractile member receiving tool may be the same as or similar to other contractile member receiving tools described elsewhere herein, and may include, for example, one, all, or some of an outer housing, a tubular shaft at least partially disposed within the outer housing, an inner shaft, a distal force applicator, a spring, and a contraction amplification knob accessible from the outside of the outer housing.

The inner shaft may (a) be partially disposed within the proximal longitudinal portion of the tubular shaft such that the inner shaft can slide axially relative to the tubular shaft, (b) be shaped to define an inner shaft retractor receiving channel, and (c) include a lock configured to (i) allow the retractor to slide relative to the inner shaft retractor receiving channel when in an unlocked state, and (ii) lock the retractor axially relative to the inner shaft when in a locked state.

The distal force applicator may (a) be at least partially disposed within the distal longitudinal portion of the tubular shaft, and (b) be shaped to define a distal force applicator retraction member receiving channel that allows the retraction member to slide through therein, the shank retraction member receiving channel (a) extending from the distal end of the shank portion to the proximal end, and (b) including an inner shaft retraction member receiving channel and a distal force applicator retraction member receiving channel.

The spring can be housed within the tubular shaft, connecting the distal force applicator and the distal portion of the inner shaft.

The method also includes changing the lock from an unlocked state to a locked state.

For some applications, the method includes, then, actuating a contraction-promoting knob to cause the handle portion to receive a continuous portion of the contraction member until the contraction member is tensioned by: advancing the tubular shaft proximally relative to the outer housing, which advances the distal force applicator proximally relative to the outer housing, which applies a proximally guiding force to the spring, which pushes the inner shaft proximally relative to the outer housing, which pulls the contraction member proximally; and then, once the contraction member is tensioned, actuating the contraction-promoting knob to increase the tension in the contraction member by the inner shaft proximally pulling the contraction member proximally by the inner shaft being pushed proximally relative to the outer housing by the spring (to a lesser extent than the advancement of the tubular shaft proximally relative to the outer housing).

For some applications, the actuation contraction amplification knob includes rotating the contraction amplification knob.

In some applications, the tubular shaft and the contraction-promoting knob are threaded together, and the shank portion is configured such that actuation of the contraction-promoting knob rotates the tubular shaft, thereby advancing the tubular shaft proximally relative to the outer housing.

For some applications, the inner shaft protrudes partially beyond the proximal end of the outer housing, and the tubular shaft and the inner shaft together provide a non-electromechanical force gauge, wherein the relative axial position of the tubular shaft with respect to the inner shaft provides a visual indication of a measure of tension in the contraction member, and the method also includes viewing this visual indication.

For some applications, the inner shaft marking has multiple reference marks arranged along the inner shaft to indicate the relative axial position of the tubular shaft with respect to the inner shaft.

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

For some applications, the tension limiting locking assembly is configured to axially lock the inner shaft relative to the outer housing when the tubular shaft is positioned at a predetermined relative axial position relative to the inner shaft, thereby limiting the maximum tension that the inner shaft can apply to the contraction member.

For some applications, the tension limiting locking assembly includes a pawl arranged to axially lock the inner shaft relative to the outer housing when the tubular shaft is positioned at a predetermined relative axial position relative to the inner shaft, thereby limiting the maximum tension that the inner shaft can apply to the contraction member.

For some applications, the pawl is axially fixed to the inner shaft and is configured to move radially outward to engage the outer housing in order to lock the inner shaft axially relative to the outer housing.

For some applications, the tension limiting locking assembly also includes multiple indentations, with the outer housing shaped to define the multiple indentations, a pawl capable of engaging these indentations to axially lock the inner shaft relative to the outer housing, and a shank portion arranged such that when the tubular shaft is positioned relative to the inner shaft in a predetermined relative axial position, a particular indentation engaging the pawl depends on the relative axial position of the inner shaft relative to the outer housing.

For some applications, the proximal longitudinal portion of the tubular shaft is shaped to define an elongated opening through which the pawl passes when the inner shaft is axially locked relative to the outer housing.

For some applications, the tubular shaft includes one or more tracks that extend side-by-side with a longitudinal portion of an elongated opening and are arranged as follows:

(a) When the tubular shaft is positioned distally relative to the inner shaft in a predetermined relative axial position, the pawl is prevented from axially locking the inner shaft relative to the outer housing, and

(b) When the tubular shaft is set in a predetermined relative axial position relative to the inner shaft, the pawl is allowed to lock the inner shaft axially.

For some applications, the one or more tracks are shaped to define one or more corresponding ramp portions such that after the pawl axially locks the inner shaft relative to the outer housing when the tubular shaft is set in a predetermined relative axial position relative to the inner shaft, subsequent distal movement of the tubular shaft and thus distal movement of the one or more tracks relative to the inner shaft disengages the pawl from the outer housing.

For some applications, the inner shaft protrudes partially beyond the proximal end of the outer housing, and the tubular shaft and the inner shaft together provide a non-electromechanical force gauge, wherein the relative axial position of the tubular shaft with respect to the inner shaft provides a visual indication of a measure of tension in the contraction member, and the method also includes viewing this visual indication.

For some applications, implantable structures include implantable annulusoplasty structures, and advancing implantable structures includes advancing implantable annulusoplasty structures toward the heart.

For some applications, the implantable annulusoplasty structure includes a flexible cannula, and the implantable annulusoplasty structure and the constrictor are advanced toward the heart, such that the constrictor extends along the cannula and extends away from the cannula.

According to some applications, a method is also provided, which includes: 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 of a handle portion of a retractable member receiving tool.

The shrink-fit member receiving tool may be the same as or similar to other shrink-fit member absorbing tools described elsewhere herein or otherwise known. For example, in some applications, the shrink-fit member receiving tool includes an outer housing, a non-electromechanical force gauge, a lock, and a shrink-promoting knob. The lock may be configured to (i) allow the shrink-fit member to slide relative to the force gauge when in the unlocked state, and (ii) when in the locked state, axially lock the shrink-fit member relative to an axially movable portion of the force gauge, which is axially movable relative to the outer housing. The shrink-promoting knob is accessible from the outside of the outer housing.

The method also includes changing the lock from an unlocked state to a locked state; and then, by advancing the force gauge relative to the outer housing toward the proximal side to pull the retractable member toward the proximal side, actuating the retraction facilitator knob to cause the handle portion to receive a continuous portion of the retractable member.

The method may subsequently include, once the contraction member is tensioned, actuating a contraction facilitating knob to increase the tension in the contraction member by pulling the contraction member proximally by an axially movable portion of a force gauge, and observing a visual indication of the measure of tension in the contraction member, the visual indication being provided by the force gauge.

For some applications, force gauges include springs.

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

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

This method can be performed in procedures on live animals or in simulation/simulation procedures (e.g., on cadavers, cadaver hearts, simulators with simulated hearts, tissues, etc., anthropomorphic mannequins, etc.).

Depending on the application, a system and/or device is also provided that may include an implantable annulus shaping structure (e.g., annulus shaping ring structure, closed annulus shaping structure, closed annulus shaping ring structure, open annulus shaping structure, partial annulus shaping ring structure, or other annulus shaping device). The implantable annulus shaping structure may include a body portion and a contraction member that extends at least partially along the longitudinal length of the body portion of the annulus shaping structure. The implantable annulus shaping structure may be the same as or similar to other annulus shaping structures described elsewhere herein.

The system and/or device may also include a shrink-wrap member receiving tool. The shrink-wrap member receiving tool may be the same as or similar to other shrink-wrap member absorbing tools described elsewhere herein. The shrink-wrap member receiving tool may include one or more tubes (e.g., a single tube, a main tube, and secondary tubes, etc.). At least one tube has a lumen configured for the shrink-wrap member to pass through. The tube may be flexible, semi-rigid, or rigid. The shrink-wrap member receiving tool may also include a shrink-wrap member snare. The shrink-wrap member snare may include a distal snare portion and an elongated flexible portion coupled to the distal snare portion. The distal snare portion may be configured to snare a portion of the shrink-wrap member and pull it into the lumen. The distal snare portion may be configured to pull a portion of the shrink-wrap member through some or the entire length of the lumen (e.g., from one end to the other). The shrink-wrap member snare may include a wire containing stainless steel. The size of the lumen of the tube may be set to maintain the connection between the distal snare portion and the shrink-wrap member.

The shrink member receiving tool may include a handle portion, and a tube may be connected to the handle portion. The handle portion may include a shrink member receiving device configured to receive a continuous portion of the shrink member. The handle portion may also include a tension meter configured to measure the degree of tension of the shrink member. The shrink member receiving device may be actuated to increase the tension of the shrink member. The shrink member receiving device may optionally include a wheel with grooves configured to engage the shrink member to the wheel. The grooves may be shaped to receive an intermediate portion of the shrink member.

The distal snare portion may include a flexible ring. The lumen may be configured such that the flexible ring collapses around the contraction member when a 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.

The distal end portion of the retractable member receiving tool can be shaped to define a sharp edge, and the retractable member receiving tool can be configured to position the retractable member adjacent to the sharp edge, such that the sharp edge can cut off the retractable member.

The retractable member receiving tool may include a retractable member fastener disposed within a distal end portion of the retractable member receiving tool. The retractable member fastener may include a clamping structure. The clamping structure may be biased toward a closed state or closed position, and in the closed state/position, the clamping structure may be configured to clamp onto the retractable member passing through it. The clamping structure may also be configured such that it can be flexed to an open state or open position, wherein in the open state/position, the retractable member can move through it. The retractable member receiving tool may also include a stop removably coupled to the retractable member fastener and configured to retain the retractable member fastener in the open state/position.

The distal snare portion, the retractable member portion, and the clamping structure can be configured and sized to pass distally through the retractable member fastener and clamping structure in the open state/position. The distal snare portion can be adapted to capture and pull the retractable member portion proximally through the retractable member fastener and clamping structure, and through an alignment port in the distal end portion of the retractable member receiving tool.

The retractable member receiving tool may include a fastener-ejector movable within a distal end portion of the retractable member receiving tool. The fastener-ejector may be configured such that its movement contacts a retractable member fastener and a clamping structure and can transition them from an open state/position to a closed state/position to clamp the retractable member as it passes through. The fastener-ejector may be coupled to a stop and may be configured to be movably and removably coupled to the stop of the fastener. The distal end portion of the retractable member receiving tool may be shaped to define a sharp edge, and the retractable member receiving tool may be configured to position the retractable member adjacent to the sharp edge such that movement of the fastener-ejector against the sharp edge cuts off the retractable member after or near its extension through the fastener.

The various devices, systems, methods, etc. described above may be combined with and/or substituted for various features and components of other embodiments described elsewhere in this document.

A more complete understanding of the invention will be achieved by reading the following detailed description of the embodiments of the invention in conjunction with the accompanying drawings, in which:

Attached Figure Description

Figures 1 and 2 are schematic diagrams of examples of multi-component tubular systems used for delivery and anchoring implants and for controlling the relative spatial orientation of components of a catheter system;

Figures 3A to 3I are schematic diagrams of exemplary procedures for implanting annulus angioplasty structures to repair the mitral valve;

Figures 4A and 4B are schematic diagrams of an exemplary shrinkable member receiving tool, which is configured to shrink the shrinkable member of the petal-shaped structure of Figures 3A to 3I and cut off any excess portion of the shrinkable member;

Figures 5A to 5D are schematic diagrams of exemplary shrink-fit member receiving tools for accommodating shrink-fit members, as shown in Figures 4A to 4B.

Figures 6A and 6B are schematic diagrams of exemplary shrinkable member receiving tools shown in Figures 4A and 4B, which are used to receive shrinkable members to shrink the valve ring forming structure connected to the shrinkable members.

Figures 7A to 7E are schematic diagrams of exemplary shrinkable member receiving tools shown in Figures 4A to 4B, which are used to lock and secure the valve ring forming structure in its shrinkable state and then cut off the excess portion of the shrinkable member;

Figures 8A to 8D are schematic diagrams of examples of systems that use annulus remodeling structures to shrink a patient's valve annulus, the annulus remodeling structure including a housing that accommodates fasteners for the shrinking member;

Figures 9A to 9D are schematic diagrams of an exemplary shrinkable member receiving tool for locking and securing the petal-shaped structure of Figures 8A to 8D in its shrunken state, and subsequently cutting off the excess portion of the shrinkable member;

Figures 10A and 10B are schematic diagrams of examples of shrink member receiving tools that can be used to engage shrink members and cut off any excess parts of shrink members;

Figures 11A to 11C are schematic diagrams of examples of shrink-fit member receiving tools, which are used to lock and secure a valve ring forming structure in its shrunken state, and subsequently cut off the excess portion of the shrink-fit member;

Figures 12A to 12C are schematic diagrams of examples of systems including exemplary valve ring forming structures, which include a sleeve, a contraction member, and a lock;

Figures 13A to 13C are schematic diagrams of examples of systems including exemplary valve ring forming structures, which include a sleeve, a contraction member, and a lock;

Figure 14 is a schematic diagram of an exemplary lock that can be used to lock the periphery of a valve ring forming structure;

Figures 15A to 15C are schematic diagrams of examples of systems including exemplary valve ring forming structures, which include a sleeve, a contraction member, and a lock;

Figure 16 is a schematic diagram of an example of a system including an exemplary valve ring forming structure, which includes a sleeve, a contraction member, and a lock;

Figure 17 is a schematic diagram of an example of a system including an exemplary valve ring forming structure, which includes a sleeve, a contraction member, and a lock;

Figure 18 is a schematic diagram of an example of a system that uses a valve annulus retraction structure to shrink a patient's valve annulus, the valve annulus retraction structure including a housing that houses fasteners for the shrinkage member;

Figures 19A and 19B are schematic diagrams of an example of a system for shrinking a patient's valve annulus using a valve annulus shaping structure, which includes a housing for accommodating a shrinkage member fastener.

Figures 20A to 20F are schematic diagrams of examples of shrink member housing and shrink member cutting tools used with a valve ring forming structure, the valve ring forming structure including a housing for accommodating shrink member fasteners;

Figures 21A and 21B are schematic diagrams of examples of retractable member receiving tools for multi-component tubular systems of Figures 20A to 20F according to some applications before insertion of flexible slender retractable members;

Figures 22A and 22B are schematic diagrams of the retractable member receiving tool of Figures 21A and 21B after insertion of a flexible, slender retractable member, according to some applications.

Figures 23A to 23B, 24A to 24B, and 25A to 25B are schematic diagrams of the retraction member receiving tool of Figures 21A to 21B according to some applications, after continuous actuation of the tool's retraction facilitating knob; and

Figures 26A and 26B are schematic diagrams of the outer housing and a portion of the tubular shaft of the retractable member receiving tool of Figures 21A and 21B according to some applications.

Detailed Implementation

Referring now to Figures 1 and 2, which are schematic diagrams of an example of a multi-component tubular system 10, the multi-component tubular system provides one or more rotationally controlled steerable catheters configured to deliver an implant to a patient's heart. System 10 provides an implant delivery tool. System 10 may include a first external catheter 12, which includes a sheath configured for advancement through the patient's vascular system. For some applications, the external catheter 12 includes a sheath configured for advancement through the femoral artery toward the interatrial septum of the patient's heart. A distal steerable end portion of the external catheter 12 is configured to pass through the septum and be oriented in a desired spatial orientation. System 10 includes a second catheter or guide catheter 14, which includes a steerable distal end portion. Catheter 14 is configured for advancement through the lumen of the external catheter 12. The external catheter 12 provides a first coupling 152 (e.g., a slit 52) at its distal end portion (e.g., the portion of catheter 12 near the steerable distal end portion). The guide conduit 14 may include a second coupling 154 (e.g., a press-fit coupling 54) coupled to a displaceable protrusion 56, which is coupled to a base. As described herein, the press-fit coupling 54 (or the second coupling 154) is configured to protrude within a slit 52 (or the first coupling 152). Therefore, the slit 52 defines a second coupling receiving element.

In some embodiments, a first coupling 152 of conduit 12 defines a longer coupling, and a second coupling 154 of conduit 14 defines a shorter coupling. The first coupling 152 and the second coupling 154 of the outer conduit 12 and the guide conduit 14 respectively enable the guide conduit 14 to be axially advanced and rotated through the lumen of the outer conduit 12 until the engagement 54 of the conduit 14 is aligned and engaged with the slit 52 of the conduit 12, as will be described below. As shown in cross-section A-A of FIG1, the guide conduit 14 is configured to be concentrically disposed within the lumen of the outer conduit 12. In some embodiments, conduit 12 provides a shorter coupling, while conduit 14 provides a longer coupling. For example, conduit 14 may be shaped to provide a slit 52, and conduit 12 may include an engagement 54 configured to engage the slit 52 of conduit 14.

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

Although the slit 52 and the press-fit connector 54 are shown as being located on the distal portions of the outer conduit 12 and the guide conduit 14, respectively, the slit 52 and the connector 54 may be provided along any suitable portion of the conduits 12 and 14 (e.g., the respective proximal portions of the conduits 12 and 14).

The first connector 152 and the second connector 154 can be respectively disposed on any standard catheter. That is, the connector 152 includes a frame 50 that can be attached to the outer surface of any standard catheter (in which case a corresponding slit will be formed in the standard catheter). Additionally, the connector 154 can be attached to any standard catheter by attaching its base portion to it. The standard catheter will be appropriately adjusted to accommodate the displacement of the protrusion 56 and the connector 54 in response to a thrust applied to the connector 54.

Figure 2 illustrates 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 external conduit 12 is steerable. The distal end portion of the external conduit 12 may include a pull ring 11 connected to two or more control lines or pull wires 29a and 29b disposed within corresponding sublumens within the wall of the conduit 12 (as shown in section A-A). As shown in the exploded view, the guide conduit 14 may be configured to be concentrically disposed within the lumen of the conduit 12. As described above, the distal end portion of the guide conduit 14 is steerable. The distal end portion of the conduit 14 may include a pull ring 13 connected to two or more pull wires 31a and 31b disposed within corresponding sublumens within the wall of the conduit 14 (as shown in sections A-A and B-B).

The guiding catheter 14 can be manipulated to a desired spatial orientation to facilitate the advancement and implantation of the implant into the patient's body cavity. As shown, the implant includes annular reconstruction structure 222 (e.g., annular reconstruction ring structure, closed annular reconstruction structure, closed annular reconstruction ring structure, open annular reconstruction structure, partial annular reconstruction ring structure, etc.), which includes a flexible cannula 26 (shown in an exploded view of Figure 2). The cannula 26 may include a woven fabric mesh, such as DACRON™. The cannula 26 may be configured to be positioned only partially around the heart valve annulus (i.e., in a C-shape), and once anchored in place, the cannula is contracted to circumferentially tighten the valve annulus. However, the annular structure may also be configured to be positioned completely around the valve annulus. To tighten the valve annulus, the annular reconstruction structure or annular reconstruction ring structure 222 includes a flexible, elongated contractile member 226 extending along the cannula 26. The elongated shrinkable member 226 may comprise wire, tape, rope, or strap, and may comprise one or more of a variety of materials, such as flexible and/or hyperelastic materials, such as nitinol, polyester, stainless steel, or cobalt-chromium alloys. For some applications, the wire comprises a radiation-impermeable material. For some applications, the shrinkable member 226 comprises braided polyester stitching (e.g., Ticron). For some applications, the shrinkable member 226 is coated with polytetrafluoroethylene (PTFE). For some applications, the shrinkable member 226 comprises multiple wires that are intertwined to form a rope structure.

For the application of system 10 for delivering an implant to a patient's mitral valve, the external catheter 12 may be configured for initial advancement through the patient's vascular system until the distal end 102 of catheter 12 (which may be the most distal end or the tip) is positioned in the left atrium. The distal steerable portion of catheter 12 is then manipulated such that the distal end 102 is positioned within the left atrium with the desired spatial orientation. The manipulation procedure may be performed with the aid of imaging, such as fluoroscopy, transesophageal echocardiography, and/or echocardiography. After manipulating the distal end portion of catheter 12, a guide catheter 14 (which houses the annulus-forming structure 222) is advanced through catheter 12 to facilitate delivery and implantation of structure 222 along the annulus of the mitral valve. During delivery, at least a portion of the steerable distal end portion of catheter 14 is exposed from the distal end 102 of catheter 12 and is therefore freely maneuverable toward the annulus of the mitral valve, as described below.

In addition, system 10 includes attachment mechanisms (e.g., anchors, adhesives, clamps, jigs, fasteners, etc.), such as a plurality of anchors 32, which may be, for example, between about 5 and about 20 anchors, such as about 10 or about 16 anchors. Each anchor 32 may include a tissue engagement element 60 (e.g., a threaded tissue engagement element) and a tool coupling head 62 fixed to one end of the tissue engagement element. An anchor 32 is shown in FIG. 2 as a deployment element 38 reversibly coupled to a rotary anchor driver 36 of an anchor deployment manipulator 61. When the cannula 26 is positioned along the annulus of a heart valve, the deployment manipulator 61 is configured to advance within the lumen of the cannula 26 and deploy each anchor 32 from within the cannula 26 through the wall of the cannula 26 and into the heart tissue, thereby anchoring the cannula 26 around a portion of the valve annulus. Anchor insertion into the cannula and deployment of the anchors into the heart tissue will be described in detail below.

Anchor 32 may include biocompatible materials, such as 316LVM stainless steel. For some applications, anchor 32 includes nitinol. For some applications, anchor 32 is wholly or partially coated with a non-conductive material.

As shown in Figure 2, the deployment manipulator 61 includes an anchor driver 36 and a deployment element 38.

As shown in the exploded view of Figure 2, the cannula 26 is disposed within the lumen of the guiding catheter 14. Force is applied to the proximal end of the cannula 26 from the distal end of the reference force tube 19. As shown, the implant separation channel 18 can be advanced within the lumen of the reference force tube 19 and through the lumen of the cannula 26, such that the portion of the channel 18 disposed within the cannula is coaxial with the cannula. As shown in the enlarged image of Figure 1, the distal end 17 of the implant separation channel 18 is configured to contact the inner wall of the cannula 26 at its distal end. Additionally, the distal end portion of the channel 18 includes a radiopaque marking 1018. As shown, the tube 19 and the cannula 26 are disposed longitudinally and coaxially relative to each other.

Anchor driver 36 can be advanced within channel 18. For some applications, system 10 includes multiple anchor drivers 36, each driver coupled to a corresponding anchor 32. Each driver 36 can be advanced within channel 18 to advance and implant the anchor 32 into tissue. After implantation of the anchor 32, as described herein, the anchor 32 is detached from the driver 36, and the driver 36 is removed from channel 18. Subsequently, a new driver 36 coupled to another anchor 32 is advanced within channel 18.

As will be described below, the first anchor 32 is configured to be deployed into the cardiac tissue through the wall of the cannula when the cannula 26 is positioned along the valve annulus of the valve. After the deployment of the first anchor, the distal portion of the cannula 26 slides distally away from a portion of the implant separation channel 18. To separate the cannula 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) the reference force tube 19 is held in place in such a way that a reference force is provided to the cannula 26 at the distal end of the tube 19 so that the continuous portion of the cannula 26 is released from around the channel 18. The channel 18 is then positioned at a continuous location within the lumen of the cannula 26 while the tube 19 and/or catheter 14 are manipulated along the valve annulus of the valve toward the continuous location (as will be described below). Thus, the continuous portion of the cannula 26 provides a free lumen for the advancement of the continuous anchor 32 and the deployment of the anchor through the wall of the cannula at its continuous portion. This release of the continuous portion of the sleeve 26 creates a distance between the continuous anchors deployed from within the lumen of the sleeve 26.

For some applications, the cannula 26 includes a plurality of radiopaque markers 25 positioned along the cannula at corresponding longitudinal sites. The markers can provide an indication in radiographic images (such as fluoroscopic images) of how much cannula has been deployed at any given point during the implantation procedure, enabling the desired distance between anchors 32 to be set along the cannula. For some applications, the markers comprise radiopaque ink.

Typically, at least a portion (e.g., three, at least three, some, all, etc.) of the longitudinal sites of the radiopaque markers are longitudinally spaced at constant intervals. The longitudinal distance between the distal edges of adjacent markers and/or the distance between the proximal edges of adjacent markers can be set equal to the desired distance between adjacent anchors. For example, the markers may include a first marker, a second marker, and a third marker, with the first and second markers adjacent to each other, and the second and third markers adjacent to each other, 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, this distance can be between 3 mm and 15 mm, such as 6 mm, and the longitudinal length of each marker can be between 0.1 mm and 14 mm, such as 2 mm (e.g., if the distance is 6 mm and the length is 2 mm, then the length of the longitudinal gap between adjacent markers is 4 mm).

Each anchor 32 is connectable to a deployment element 38 of an anchor actuator 36. The anchor actuator 36 includes an elongated tube having at least one flexible distal end portion. The elongated tube of the actuator 36 extends within a lumen of a channel 18, through the system 10 toward a proximal end of a proximal handle portion 101 of the system 10. The tube of the anchor actuator 36 provides a lumen for slidably advancing an elongated rod 130 through the lumen. The rod 130 facilitates locking and unlocking of the anchor 32 with the deployment element 38, as described below. As shown in section E-E of FIG2, the proximal end of the rod 130 is connected at the proximal end of the system 10 to a component of an anchor release mechanism 28. The mechanism 28 includes a housing 135 and a finger engagement 131 connected to the proximal end of the rod 130. The finger engagement 131 is connected to the housing 135 via a spring 133 (section E-E of FIG2). The proximal end of the tube of the anchor actuator 36 is connected to the housing 135. As described below, when the finger engagement 131 is pulled proximally, the user (e.g., a doctor, healthcare professional, etc.) releases the anchor 32 from the deployment element 38, thereby pulling the rod 130 proximally.

For some applications, the anchor actuator 36 (e.g., its rotation and/or proximal-distal movement, and/or the release of the anchor 32) is electronically controllable, such as by using an external controller and/or an electric motor coupled to the proximal end of the anchor actuator and/or housing 135.

The proximal stem portion 101 can be supported by a bracket having a support leg 91 and a stem sliding track 90. The stem portion 101 includes an external catheter stem 22, a guide catheter stem 24, an implant manipulation stem 126, and an anchor release mechanism 28. The stem 22 is coupled to the proximal end of the external catheter 12. The stem 24 is coupled to the proximal portion of the guide catheter 14. The stem 126 is coupled to the proximal portion of the reference force tube 19, and linear movement of the stem 126 relative to the stem 24 causes the reference force tube 19 (and thus typically structure 222) to move through the catheter 14. As described above, the housing 135 of the anchor release mechanism 28 is coupled to the proximal portion of the tube of the anchor actuator 36. The relative positioning of each component of the concentrically arranged components of the system 10 is shown in the exploded view and sections A-A, B-B, C-C, and D-D of FIG. 2.

The support for the proximal stem portion 101 is movable distally and proximally to control the position of the entire multi-component system 10, particularly adjusting the distance between the distal end 102 of the catheter 12 and the interatrial septum. The stem 22 includes an operating knob 210 coupled to pull wires 29a and 29b disposed within corresponding sublumens in the wall of the external catheter 12. Rotation of the knob 210 adjusts the tension of the wires 29a and 29b, which in turn applies force to the pull loop 11 at the distal end portion of the external catheter 12. This force manipulates 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 manipulated in a first plane parallel to the plane of the valve annulus (e.g., in a direction from the interatrial septum toward the peripheral wall of the atrium). For some applications, the distal end portion of the catheter 12 may be pre-shaped to point downward toward the valve. For other applications, the distal end portion of the catheter 12 may be pulled to present a downward-pointing orientation toward the valve. For some applications, the distal portion of catheter 12 is not made to point downward toward the valve.

The handle 24 can be coupled to the track 90 via a first mounting member 92. The mounting member 92 can slide proximally and distally along the track 90 to control the axial position of the guiding catheter 14 relative to the outer catheter 12. The mounting member 92 can slide via a control knob 216. For example, the control knob 216 of the mounting member 92 can control the proximal and distal axial movement of the distal steerable portion of the guiding catheter 14 relative to the distal end 102 of the outer catheter 12. The handle 24 may include an operating knob 214 coupled to pull wires 31a and 31b disposed in corresponding sublumens within the wall of the guiding catheter 14. Rotation of the knob 214 adjusts the tension of the wires 31a and 31b, which in turn applies a force to the pull loop 13 at the distal end portion of the guiding catheter 14. This force is directed downwards and toward the valve annulus of the distal end portion of the guiding catheter 14 within a second plane within the atrium of the patient's heart. As described below, the distal end portion of the guiding catheter 14 can be manipulated in a second plane that is substantially perpendicular to a first plane in which the distal end portion of the external catheter 12 is manipulated.

The combined manipulation of the respective distal portions of catheters 12 and 14 guides the cannula 26 downward toward the valve annulus (e.g., via manipulation of the distal portion of catheter 12) and along the periphery of the valve annulus (e.g., from the posterior portion of the valve to the anterior portion of the valve, and vice versa) via manipulation of the distal portion of catheter 12.

For some applications, the handle 22 can be tilted by the user (e.g., an operating physician) to further adjust the position of the distal end of the catheter 12.

For some applications, the handle 22 includes an indicator that indicates the degree of directional (e.g., bending) of the distal end portion of the catheter 12 produced by the knob 210. For some applications, the handle 24 includes an indicator that indicates the degree of directional (e.g., bending) of the distal end portion of the catheter 12 produced by the knob 214.

As described herein, the first connector 152 and the second connector 154 (e.g., slit 52 and engagement 54, respectively) of the external catheter 12 and the guiding catheter 14 provide controlled maneuverability systems, wherein during manipulation and bending of the distal end portion of the guiding catheter 14, the distal end portion of the external catheter 12 remains in its maneuverability configuration or spatial orientation without substantially affecting the manipulation or bending of the distal end portion of the guiding catheter 14. Therefore, the first connector 152 and the second connector 154 respectively minimize the influence of the distal end portion of the external catheter 12 on the manipulation and bending of the catheter 14. That is, the first connector 152 and the second connector 154 of the external catheter 12 and the guiding catheter 14 respectively collectively define a relative spatial orientation control device that rotatably locks the relative spatial orientation of the maneuverable distal end portion and the bent portion of the external catheter 12 relative to the maneuverable distal end portion and the bent portion of the guiding catheter 14.

The retraction member 226 exits from the lumen in the wall of the guide tube 14 at the portion of the handle portion 101 located between the handle portions 22 and 24.

The handle 126 can be coupled to the track 90 via a second mounting member 93. The mounting member 93 is slidable proximally and distally along the track to control the axial position of at least the proximal portion of the reference force tube 19 and the cannula 26 relative to the guide catheter 14. The mounting member 93 can be slidable via a control knob. For example, the control knob of the mounting member 93 can control the proximal and distal axial movement of at least the proximal portion of the tube 19 and the cannula 26 relative to the distal end 104 of the guide catheter 14. Together with the manipulation of the distal end portion of the guide catheter 14, this movement of the tube 19 and at least the proximal portion of the cannula 26 during deployment of the anchor 32 from within the lumen of the cannula 26 causes the proximal portion of the cannula 26 to move toward the desired portion of the valve annulus tissue, as described below.

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 can be pulled proximally while (2) the reference force tube 19 is held in place. The proximally end of the channel 18 can be connected to a knob 94, which adjusts the axial position of the channel 18 proximally and distally relative to the reference force tube 19 and the sleeve 26.

The handle portion 101 may include a release-determining facilitator 127, such as a latch or button, which automatically engages when a given length of cannula 26 has been advanced away from channel 18 (e.g., when channel 18 is in a given position relative to tube 19); typically just before cannula 26 is completely separated from channel 18. Engagement of facilitator 127 inhibits proximal movement of channel 18 relative to tube 19, thereby reducing (e.g., preventing) the likelihood of accidental release of cannula 26. To release cannula 26 (e.g., to separate channel 18 from cannula), the user (e.g., an operating physician) must disengage facilitator 127, such as by pushing the button, before continuing to withdraw channel 18 proximally. When engaged, facilitator 127 may also inhibit distal movement of channel 18 relative to tube 19.

The handle portion 101 (including handles 22, 24, and 126 and the anchor release mechanism 28) may have a length L1 between 65 cm and 85 cm (e.g., 76 cm). As shown, a large portion of the main body of the external catheter handle 22 may be positioned at a non-zero angle relative to the longitudinal axis 7 of a plurality of components of the system 10. An actuation mechanism provided by the handle 22 for manipulating the distal end portion of the catheter 12 is disposed within the portion of the handle 22 positioned at a non-zero angle relative to the axis 7. The handle 22 includes an inline tubular portion 21, which is longitudinally coaxial along the axis 7 and coaxial with respect to the handles 24 and 126 and the release mechanism 28. The tubular portion 21 is shaped to define a lumen for inserting the guide catheter 14 therein and subsequently into the lumen of the external catheter 12. The tubular portion 21 has a length L24 between 7 cm and 11 cm (e.g., 7 cm). The spatial orientation of most of the handle 22 at an angle relative to the axis 7 reduces the total functional length of the handle portion 101.

Referring now to Figures 3A to 3I, which are schematic diagrams of an example of a procedure for implanting an annulus retraction ring structure 222 (e.g., an annulus retraction ring structure, a closed annulus retraction ring structure, an open annulus retraction ring structure, a partial annulus retraction ring structure, etc.) to repair the mitral valve 230. This procedure is an example of a procedure that can be performed using system 10.

The annulus reshaping structure or annulus reshaping ring structure 222 can be used to repair dilated valvular annulus of atrioventricular valves (such as the mitral valve 230). For some applications, the annulus reshaping structure is configured to be placed only partially around the valvular annulus (e.g., in a C-shape) and, once anchored or otherwise secured in place, contracts to circumferentially tighten the valvular annulus. For some applications, the annulus reshaping structure is configured to be placed completely around the valvular annulus (e.g., in a closed shape, such as circular, elliptical, D-shaped, etc.) and, once secured in place, contracts to circumferentially tighten the valvular annulus. The annulus reshaping structure may include a flexible sheath 26. The annulus reshaping structure may also include and/or be used with attachment devices (e.g., anchors, fasteners, clamps, sutures, jigs, etc.) such as multiple anchors 32. Anchoring deployment manipulator 61 is advanced into the lumen of cannula 26 and deploys the anchoring element from within the lumen through the wall of the cannula and into the cardiac tissue, thereby anchoring the cannula around a portion of the valve annulus. For some applications, the annulus reshaping structure or annulus reshaping ring structure 222 is implemented using the technology described in U.S. Application No. 12/437,103 (issued May 7, 2009, US 8,715,342) and/or U.S. Application No. 12/689,635 (issued January 19, 2010, US 8,545,553), both of which are assigned to the assignee of this application and are incorporated herein by reference.

As shown in Figure 3A, the procedure can begin by advancing the semi-rigid guidewire 202 into the patient's right atrium 220. The procedure can be performed with the aid of imaging techniques such as fluoroscopy, transesophageal echocardiography, and/or echocardiography.

As shown in Figure 3B, guidewire 202 provides guidance for the subsequent advancement of external catheter 12 into the right atrium. Once the distal portion of catheter 12 enters the right atrium, guidewire 202 is retracted from the patient. Catheter 12 may include a 14-24F sheath, although any size may be selected to fit a given patient. Catheter 12 is advanced into the right atrium via the vascular system using a suitable source determined for a given patient. For example:

• Catheter 12 can be introduced into the patient's femoral vein, pass through the inferior vena cava 223, enter the right atrium 220, and then pass through the septum (e.g., through the fossa ovalis) into the left atrium 224;

• Catheter 12 can be inserted into the basilic vein, pass through the subclavian vein to the superior vena cava, enter the right atrium 220, and then pass through the septum (e.g., through the fossa ovalis) into the left atrium 224; or

• Catheter 12 can be introduced into the external jugular vein, pass through the subclavian vein to the superior vena cava, enter the right atrium 220, and then pass through the septum (e.g., through the fossa ovalis) into the left atrium 224.

For some applications, catheter 12 is advanced through the patient’s inferior vena cava 223 (as shown) and into the right atrium 220 using an appropriate source point for a given patient.

The catheter 12 can be advanced distally until the sheath reaches the interatrial septum and the guidewire 202 is withdrawn, as shown in Figure 3C.

As shown in Figure 3D, an elastic needle 206 and a dilator (not shown) are advanced through catheter 12 and into the heart. To advance catheter 12 transseptally into the left atrium 224, the dilator is advanced into the septum, and the needle 206 is pushed from within the dilator, allowing it to pierce the septum to create an opening that facilitates the passage of the dilator and subsequently the passage of catheter 12 into the left atrium 224. The dilator passes through a 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 this hollow shaft may be shaped to define a tapered distal end. This tapered distal end is initially advanced through the hole formed by the needle 206. The hole is enlarged as the gradually increasing diameter of the distal end of the dilator is pushed through the hole in the septum. For some applications, the distal end 102 of catheter 12 is tapered to allow the distal portion of catheter 12 to pass through the opening in the septum.

After catheter 12 is advanced through the diaphragm into the left atrium, the dilator and needle 206 can be withdrawn from catheter 12, as shown in Figure 3E. Once the distal portion of catheter 12 is positioned within atrium 224, the steerable distal end portion of catheter 12 (e.g., the curved portion 1203 of catheter 12) can be manipulated in a first plane parallel to the plane of the annulus of mitral valve 230. This manipulation moves the distal end portion of catheter 12 in a direction from the interatrial septum toward the surrounding atrial wall, as indicated by the arrow in atrium 224. As described above, manipulation of the distal portion of catheter 12 can be performed via the actuation knob 210 of the handle 22 in the handle portion 101 (Figures 1 and 2).

As shown in Figure 3F, the annulus shaping structure or annulus shaping ring structure 222 (not shown for clarity, but having an anchor deployment manipulator 61) is advanced through a guide catheter 14, which in turn is advanced through catheter 12 into the left atrium 224. As shown in Figure 3F, the exposed distal end portion 114 of catheter 14 (e.g., the curved portion 1403) extends beyond the distal end 102 of catheter 12. The exposed distal end portion 114 then (1) is manipulated toward the annulus of valve 230 along a plane perpendicular to the manipulation plane of catheter 12 and perpendicular to valve 230, and (2) is curved toward valve 230 via the curved portion 1403. As described above, manipulation of the distal portion of catheter 14 is performed via an actuation knob 214 of the handle 24 in the handle portion 101 (Figures 1 and 2).

As shown in Figure 3G, the distal end 251 of the cannula 26 is positioned near the left fibrous triangle 242 of the annulus 240 of the mitral valve 230 (note that, for clarity, the distal end 251 of the cannula 26 is schematically shown in a cross-sectional view of the heart, although the left triangle 242 is not actually located in the cross-sectional plane shown, but rather outside the page closer to the observer). Alternatively, the distal end of the cannula 26 is positioned near the right fibrous triangle 244 of the mitral valve (configuration not shown). Further alternatively, the distal end of the cannula is not positioned near either of the triangles, but rather in other locations near the mitral valve, such as near the anterior or posterior commissure. Once positioned at the desired site near the selected triangular region, the deployment manipulator 61 deploys the first anchor 32 through the wall of the cannula 26 (by penetrating the wall of the cannula in a direction parallel to the central longitudinal axis of the deployment manipulator 61 or the anchor driver 36, through the distal end of the channel 18, and/or penetrating the wall of the cannula in a direction parallel to the central longitudinal axis of the tissue engagement element 60 of the anchor 32) into the cardiac tissue near the triangular region. After the anchor 32 is deployed into the cardiac tissue, the deployment element 38 is disengaged from the anchor 32 by moving the lever 130 proximally.

Anchors 32 can be deployed from the distal end of manipulator 61, positioned such that the central longitudinal axis passing through the distal end of manipulator 61 forms an angle of approximately 20 to 90 degrees with the surface of the cardiac tissue, such as 45 to 90 degrees, or approximately 75 to 90 degrees, or approximately 90 degrees. Anchors 32 can be deployed into the cardiac tissue from the distal end of manipulator 61 in a direction parallel to the central longitudinal axis passing through the distal end of manipulator 61. This angle can be provided and/or maintained by a channel 18 that is more rigid than cannula 26. The distal end 17 of channel 18 (shown in FIG. 2) can be close to the surface of the cardiac tissue (and the wall of cannula 26 abutting the surface of the cardiac tissue) such that each anchor 32 is barely exposed from channel 18 before penetrating the cannula and tissue. For example, the distal end 17 of channel 18 can be placed (e.g., pushed) against the wall of cannula to clamp the cannula onto the cardiac tissue.

For some applications, the distal end 17 of channel 18 is positioned against the cardiac tissue (via the wall of the cannula) to stabilize the distal end during deployment and anchoring of each anchor 32, thereby facilitating anchoring. For some applications, pushing the distal end 17 against the cardiac tissue (via the wall of the cannula) temporarily deforms the cardiac tissue at the contact point. This deformation can facilitate the identification of the contact point using imaging techniques (e.g., by identifying deformation at the boundary between the cardiac tissue and blood), and thereby facilitates the correct positioning of the anchor.

For some applications, the anchor 32 can be deployed from the side portion of the manipulator 61.

Referring now to Figures 3G and 2. After the deployment of the first anchor, the distal portion of the cannula 26 can be separated from a portion of the implant separation channel 18. To separate this portion of the cannula 26 from the outer surface of the channel 18, (1) the channel 18 can be pulled proximally while (2) the reference force tube 19 is held in place by providing a reference force to the cannula 26 at its distal end, so that the continuous portion of the cannula 26 can be released from retraction around the channel 18. To separate the cannula 26 from the outer surface of the channel 18, (1) the channel 18 can be pulled proximally while (2) the reference force tube 19 is held in place. An indicator on the handle 126 (such as indicator 2120 described in PCT patent application PCT/IL2012/050451 granted to Sheps et al., disclosed in WO/2013/069019, which is incorporated herein by reference) provides indication of how much the channel 18 has been withdrawn from the cannula 26 (i.e., how much the delivery tool has separated from the cannula 26, and how much the cannula has been advanced away from the channel 18 and abutted against the tissue). The proximal end of the channel 18 is coupled to a knob 94 (FIG. 2), which adjusts the axial position of the channel 18 proximally and distally relative to the reference force tube 19 and the cannula 26. As shown in FIG. 3H, the deployment manipulator 61 is repositioned along the valve annulus 240 to another site selected for deployment of the second anchor 32. Referring now to FIG. 1 and FIG. 3H, this repositioning of the manipulator 61 is achieved by the following steps:

(1) In a first plane parallel to the valve annulus 240 of the valve 230, and by bending the curved portion 1203 of the catheter 12, the distal end portion of the catheter 12 is manipulated to the desired spatial orientation (e.g., by the operating knob 210 of the handle 22).

(2) In a second plane perpendicular to the valve annulus 240 of the valve 230, and by bending the curved portion 1405 (specifically the curved portion 1403) of the catheter 14, the distal end portion of the catheter 14 is manipulated to the desired spatial orientation (e.g., by the operating knob 214 of the handle 24).

(3) Move the catheter 14 axially relative to the catheter 12 via the knob 216.

(4) The catheters 12 and 14 are moved by axially moving the supports of the handles 22 and 24.

(5) Axially move the tube 19 and sleeve 26 by sliding the bracket 93 along the track 90 via the knob 95, and/or

(6) Move channel 18 relative to tube 19 by actuating knob 94.

Typically, the first anchor is deployed distally within the cannula (usually at the distal tip of the cannula or within a few millimeters of the distal tip), and each subsequent anchor is deployed more proximally, such that the cannula gradually separates distally from the channel 18 of the deployment manipulator 61 during the anchoring procedure (i.e., the channel 18 is withdrawn from the cannula 26, and the handle 126 moves distally to retract the tool, thus preparing the successive proximal portions of the cannula 26 for subsequent anchor implantation). The deployed first anchor 32 holds the anchored end of the cannula 26 in place, thereby pulling the cannula from the site of the first anchor toward the site of the second anchor. As the cannula 26 separates from the channel 18, the deployment manipulator 61 can be moved generally laterally along the cardiac tissue, as shown in Figure 3H. The deployment manipulator 61 deploys the second anchor through the wall of the cannula 26 into the cardiac tissue at the second site. Depending on the tension applied between the first and second anchor points, the portion of the sleeve 26 therebetween may maintain a tubular shape or may become flattened, which may help reduce any interference between the ring and blood flow.

As shown in Figure 3I, the deployment manipulator 61 can be repositioned along the valve annulus to another site, where a corresponding anchor point is deployed, until the final anchor point is deployed near the right fibrous triangle 244 (or, if anchoring begins in the right triangle, near the left fibrous triangle 242). Optionally, the final anchor point is not deployed near the triangle, but elsewhere 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 retraction member 226. As described below, the retraction member receiving tool is then inserted through the retraction member 226 and advanced along it toward the structure 222, and the structure 222 is retracted by adjusting the tension level of the retraction member 226 (not shown in Figure 3I, but (i) the advancement of the retraction member receiving tool on the retraction member 226 is described with reference to Figures 4A to 5D with necessary modifications, and (ii) the application of tension to the member 226 is described below with reference to Figures 6A to 6B).

Once the desired level of adjustment of structure 222 is achieved (e.g., by monitoring the degree of valvular regurgitation under echocardiographic and/or fluoroscopic guidance), the contractile member receiving tool (1) locks the contractile member 226 to maintain a certain degree of tension on member 226, thereby holding structure 222 in a contracted state, and (2) cuts off any excess portion of the contractile member 226 and then removes it from the heart. For some applications, the distal portion of the guiding member 86 may remain inside the patient's heart, and the proximal end may be accessible externally, for example, using a port. For such applications, the adjustment mechanism 40 may be accessible at a later stage after the initial implantation and adjustment of the ring structure 222.

For some applications, a re-access filament 288 may be provided, which is coupled to a proximal portion of the implant (e.g., a portion of the last deployed implant), such as to the last anchor 32 (as shown in FIG. 3I) or cannula 26, such that, during anchoring, the filament extends proximally, such as through catheter 14 and/or catheter 12, out of the subject's body. If, after implantation of the annulus angioplasty structure 222 (e.g., and after adjustment), it is determined that one or more anchors 32 require adjustment or retrieval, the re-access filament 288 facilitates the guidance of an anchor manipulation tool to and/or into the annulus angioplasty structure 222 and its lumen. For example, such an anchor manipulation tool may include the anchor manipulation tool described in PCT patent application PCT/IL2013/050861 entitled "Percutaneous tissue anchor techniques," filed October 23, 2013, and granted to Herman et al., entitled "Percutaneous tissue anchor techniques," which is incorporated herein by reference. The systems, devices and technologies described in this patent application can be used in combination with the systems, devices and technologies described in the PCT patent application PCT/IL2013/050861.

As shown in the figure, the cannula 26 of the ring structure 222 includes a plurality of radiopaque markers 25 positioned along the cannula at corresponding longitudinal sites to indicate the target area specified by the anchors. The markers can provide an indication in radiographic images (such as fluoroscopic images) of how many cannulas 26 are deployed at any given point during the implantation procedure, so as to enable the desired distance between the anchors 32 to be set along the cannula 26.

For some applications, and as shown in Figure 3I, the anchor 32 is deployed at longitudinal positions of the sleeve 26 where a radiopaque mark 25 is provided (e.g., the anchor is driven through radiopaque ink from the radiopaque mark). Alternatively, the anchor 32 may be deployed at longitudinal positions of the sleeve 26 between the marks 25. For example, when the sleeve 26 is dispensed from the channel 18 (i.e., when the sleeve 26 is advanced relative to the channel 18 and/or when the channel 18 is withdrawn from the sleeve 26), the appearance of the mark 25 at the distal end of the channel 18 (e.g., the mark 25 becomes aligned with mark 1018 of the channel 18) can indicate that the correct length of the sleeve 26 has been dispensed. Subsequently, limited movement of the channel relative to the sleeve may occur. For example, when the channel 18 is placed against the valve ring, the channel can tension the portion of the sleeve 26 between the previously deployed anchor and the distal end of the channel, such that when the anchor is deployed, it passes slightly through the sleeve proximal to the mark 25 (e.g., 1 mm to 2 mm proximal to the mark).

Alternatively, with necessary modifications, a valve annulus reconstruction structure can be implanted via a right or left thoracotomy.

For some applications, after cannula 26 is implanted along the valve annulus, an excess portion of cannula 26 may remain at the proximal portion of the cannula. In such applications, after removal of manipulator 61, a cutting tool (not shown) may be advanced within channel 18 and into the lumen of the excess portion of cannula 26 (e.g., from within cannula 26) to cut the cannula proximal to the anchor 32 deployed on the proximal side.

Referring now to Figures 4A and 4B, which are schematic diagrams of an exemplary system 10 including an exemplary retractable member receiving tool 300 configured to retract a retractable member 226 and cut off any excess portion of the retractable member 226. The tool 300 includes a handle portion 320 and an elongated sheath 310 coupled thereto. The sheath 310 encloses a main tube 330 and a secondary tube 340 disposed side-by-side with the main tube 330. Both the main tube 330 and the secondary tube 340 are coupled to the handle portion 320 at their respective proximal ends. The secondary tube 340 has a secondary tube lumen configured for the retractable member 226 to pass through. The tool 300 defines a longitudinal axis 301.

For some applications, the sleeve 310 is shaped to define a lumen within the wall of the sleeve 310. For such applications, the tool 300 does not include a secondary tube 340; instead, the lumen within the wall of the sleeve 310 serves as the secondary tube 340, and the main tube lumen defined by the wall of the sleeve 310 serves as the main tube 330.

The sheath 310, main tube 330, and auxiliary tube 340 can be flexible, such that they are configured for passage through a patient's vascular system during transvascular or transcatheter procedures. However, similar features can be used in surgical procedures. For some applications, the sheath 310, main tube 330, and auxiliary tube 340 comprise silicone. For some applications, they comprise polyurethane.

Tool 300 may include a contraction member snare 350, which includes a distal snare portion 352 and an elongated flexible portion 354 connected to the distal snare portion 352. The distal snare portion 352 is configured to snare a portion of the contraction member 226 as will be described below, and its size is set to extend through the lumen of the secondary tube 340 to pull the contraction member 226 through the length of the secondary tube 340.

The distal snare portion 352 may define an annular portion, as shown in the figure. For some applications, the distal snare portion 352 is shaped to define a hook.

Tool 300 may include a distal end portion 333 having a distal tip 331 defining a distal end of tool 300. A main pipe 330 terminates at the distal end portion 333. The distal end portion 333 includes a housing 332 shaped to retain and removably engage with a retractable member fastener 360. The retractable member fastener 360 includes a clamping structure that may be biased toward presenting a closed state or closed position, and in the closed state/position, the clamping structure may be configured to clamp onto a retractable member 226 (not shown) passing therethrough. The clamping structure may also be configured such that it is flexible to an open state through which the retractable member 226 (not shown) is movable.

Tool 300 may include a fastener-ejector 335 movable within a distal end portion 333 of the retractable member receiving tool 300. Movement of the fastener-ejector 335 converts the retractable member fastener 360 (or its clamping structure) from its open state to its closed state to clamp onto the retractable member 226 passing therethrough, as will be described below. Tool 300 includes a stop 362 removably coupled to the retractable member fastener 360 and configured to hold the retractable member fastener 360 in the open state, as shown in section A-A of FIG4A. The stop 362 includes one or more (e.g., two) tips 337 that hold the fastener 360 in the open state. The ejector 335 is coupled to the stop 362 and moves the stop 362 removably coupled to the fastener 360 to convert the fastener 360 from the open state to the closed state, as described below.

Figure 4B shows the handle portion 320 of the tool 300, with the outer casing removed to view the interior of the handle portion 320. The handle portion 320 includes a retraction member receiving device 322 configured to receive a continuous portion (not shown) of the retraction member 226, as described below. The retraction member receiving device 322 can be actuated to increase the tension of the retraction member, as described below. The tension of the retraction member 226 is measured by a tension gauge 324 in the handle portion 320.

The retractable member receiving device 322 may optionally include a wheel having two opposing wedge-shaped portions 325 that together define a groove 326 configured to engage the retractable member 226 to the wheel of the device 322. The wedge-shaped portions 325 may be shaped to receive any portion of the retractable member 226, such as the proximal end and/or the middle portion of the member 226. For some applications, the opposing wedge-shaped portions 325 are configured to grip the retractable member 226. As shown, the wheel of the device 322 may have a digital indicator to indicate the number of rotations of the wheel.

As shown in the figure, the handle portion 320 is connected to the corresponding proximal portions of the main tube 330 and the secondary tube 340.

The handle portion 320 may be shaped to define a lumen 328 for the snare 350 to pass through the lumen of the sub-tube 340. The snare 350 passes through the lumen 328 and over the groove 326 of the contraction member receiving device 322. Typically, but not necessarily, the device 322 does not receive the snare 350; instead, the snare 350 passes through the groove 326. As described below, pulling the snare 350 pulls the contraction member 226 to which it is attached, causing the contraction member 226 to be pulled through the sub-tube 340, through the lumen 328, and ultimately toward the contraction member receiving device 322. Once the proximal end of the contraction member 226 (or the portion near the proximal end of the member 226) is pulled through the tube 340 and through the lumen 328, the contraction member 226 is attached to the contraction member receiving device 322 by being fed into the groove 326. Then, the contraction member receiving device 322 is actuated to apply tension to the contraction member 226, thereby applying tension to the annulus shaping structure 222 implanted along the annulus. With each rotation of the wheel of the device 322, a continuous portion of the contraction member 226 is wound within the groove 326 of the device 322.

Figures 5A to 5D are schematic diagrams of an exemplary retraction member receiving tool 300 that can be used to receive the retraction member 226. At this stage, the annulus reshaping structure or annulus reshaping ring structure 222 has been implanted along the annulus 240, as described above with reference to Figures 3A to 3I. Once the structure 222 has been implanted along the annulus, the retraction member 226 extends away from the structure 222 and through the patient's vascular system, such that the proximal end portion of the member 226 is positioned outside the patient's body.

The constriction member 226 can exit the cannula 26 of structure 222 at any suitable location along structure 222. For example, the constriction member 226 can exit the cannula 26 of structure 222 at a portion of the left fibrous triangle adjacent to the valve, as shown. For some applications, the constriction member 226 exits the cannula 26 of structure 222 at a portion of the right fibrous triangle adjacent to the valve. For some applications, the constriction member 226 exits the cannula 26 of structure 222 at a middle portion of structure 222.

As shown in the figure, structure 222 includes a sleeve 26 defining a main body portion of structure 222. The contraction member 226 has a first portion 420 extending along the longitudinal length of the main body portion of the annular forming structure 222. The first portion 420 can extend along the longitudinal length of structure 222 when structure 222 is in a linear state and in a bent state, as shown in Figure 5A. The contraction member 226 also defines a second portion 422 extending away from the main body portion of the annular forming structure 222.

In Figure 5A, the user (e.g., an operating physician) can hold the distal end of the tool 300 with one hand and the proximal end portion of the contraction member 226 with the other hand. The user or physician passes the proximal end portion of the contraction member 226 through the distal snare portion 352 of the contraction member snare 350.

Figure 5B shows a tool 300 in a state where the distal snare portion 352 is fitted around the retractor member 226. For some applications, the distal snare portion 352 is shaped to increase the connection between the snare 350 and the retractor member 226. For example, for some applications, the distal snare portion 352 is corrugated to increase friction between the snare portion 352 and the retractor member 226. For some applications, the distal snare portion 352 may include a coiled portion to increase friction between the snare portion 352 and the retractor member 226. For some applications, the snare 350 comprises a metal wire. For some applications, the snare 350 comprises a metal wire containing stainless steel. The snare 350 (including the distal snare portion 352) can have various sizes, for example, diameters from 0.15 mm to 0.5 mm or from 0.15 mm to 0.35 mm.

Referring now to Figures 4A and 5B. As shown in section A-A of Figure 4A, the contraction member snare 350 passes through alignment ports 339 and 341 in the distal end portion 333 of the tool 300.

The snare 350 can be pulled proximally, for example, by a user or doctor holding the proximal exposed end 351 of the snare 350 away from the tool 300. As shown in FIG5C, pulling the snare 350 proximally pulls the distal snare portion 352 and the retractable member 226 that passes through it through the distal tip 331 of the tool 300, through the fastener provided in the distal end portion 333 of the tool 300, through the alignment ports 339 and 341 in the distal end portion 333 of the tool 300, and subsequently through the lumen of the secondary tube 340.

The snare 350 is pulled until the distal snare portion 352 enters the lumen of the secondary tube 340. Therefore, the looped portion of the distal snare portion 352 is compressed and collapses around the contraction member 226 passing through it, so as to maintain the connection between the snare portion 352 and the contraction member 226 as the elongated flexible portion 354 (shown in FIG. 5B) is pulled through the lumen of the secondary tube 340. As the looped portion of the snare portion 352 collapses within the lumen of the secondary tube 340, the portion of the contraction member 226 encircled 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 due to the relatively small diameter of the secondary tube 340, which is 0.5 mm to 1.0 mm.

In Figure 5D, the snare 350 is fully pulled through the secondary tube 340, through the lumen 328 of the handle portion 320, and beyond the groove 326 of the retraction member receiving device 322 in order to pull the retraction member 226 along this path. Throughout, the sheath 310 of the tool 300 is advanced through the vascular system toward the annulus shaping structure 222 implanted along the valve annulus 240 of the valve. Once the distal snare portion 352 and the portion of the retraction member 226 to which it is attached leave the lumen 328 of the handle portion 320, this portion of the retraction member 226 is engaged with the retraction member receiving device 322 by being positioned within the groove 326. For some applications, the proximal end portion of the retraction member 226 is fed into the groove 326. For some applications, the intermediate portion of the retraction member 226 (e.g., the portion near the proximal end of the retraction member 226) is fed into the groove 326. Then, the shrink member 226 is tightened by actuating (e.g., rotating) the shrink member receiving device 322, such that the continuous portion of the shrink member 226 is wound inside the shrink member receiving device 322, and the shrink member receiving device 322 receives the continuous portion.

Once the snare 350 has been pulled through the tool 300, the snare 350 can be discarded.

Referring now to Figures 6A and 6B, which are schematic diagrams of an exemplary tool 300 for pulling the contraction member 226 to contract the contraction member 226 and thereby contract the valve ring forming structure or valve ring forming ring structure 222 connected thereto. The contraction member receiving device 322 is rotated to receive a continuous portion of the contraction member 226.

As shown in Figure 6A, before the rotating constrictor receiving device 322, the tension gauge 324 on the handle portion 320 shows that the tension of the constrictor 226 is zero or close to zero. Similarly, the sleeve 26 of the valve annulus forming structure 222, which is connected to the valve annulus 240, is in a relaxed, untensioned state. At this time, the tool 300 has been sufficiently advanced through the patient's vascular system, so that the distal tip 331 approaches the structure 222 arranged along the valve annulus, while the proximal portion of the constrictor 226 is positioned outside the patient's body.

In Figure 6B, the contraction member receiving device 322 is rotated to contract and apply tension to the contraction member 226. Tension gauge 324 on the handle portion 320 shows the tension of the contraction member 226 between 4 and 5. Similarly, the sleeve 26 of the valve ring forming structure 222, which is connected to the valve ring 240, is in a tensioned, contracted state. As shown in Figure 6B, the contraction member 226 is in a tensioned state relative to the tool 300.

Referring now to Figures 7A through 7E, which are schematic diagrams of an exemplary tool 300 for locking and securing the valve ring forming structure 222 in its contracted state and subsequently cutting off excess portions of the contracted member 226.

Figure 7A shows the valve ring forming structure or valve ring forming ring structure 222 in its non-contracted state. The distal tip 331 of the tool 300 can be close to the structure 222. The contraction member 226 can be passed along the sleeve 26 and exit from a portion of the sleeve 26 of the structure 222. As described above, the contraction member 226 can be passed through the tool 300 in such a way that the member 226 passes through the distal tip 331, through the contraction member fastener 360 which can be held in an open state, for example by the tip 337 of the stop 362, through the alignment ports 339 and 341 in the distal end portion 333 of the tool 300, and through the sub-tube 340.

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 retract the structure 222 by pulling the retraction member 226. During the retraction of the structure 222, the fastener 360 is not deployed.

In Figure 7C, the contraction member 226 is tensioned, and the annular forming structure 222 is contracted and in a tensioned, contracted state. Then, the distal end portion 333 of the tool 300 is used to eject and deploy the fastener 360 from within the tool 300 to lock the structure 222 in the contracted state.

Referring now to Figures 6B and 7C. Once the distal tip 331 contacts the sleeve 26, the trigger 321 (shown in Figure 6B) at the shank portion 320 of the tool 300 is partially pulled to eject and deploy the retractable 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 retractable member receiving tool 300. Movement of the fastener-ejector 335 converts the retractable member fastener 360 from its open state to its closed state to clamp onto the retractable member 226 passing therethrough. The fastener-ejector 335 is coupled to the tip 337 of the stop 362 in such a way that as the ejector 335 moves proximally within the portion 333, the stop 362 disengages from the retractable member fastener 360 as the tip 337 moves proximally away from the retractable member fastener 360. Once the retractable member fastener 360 is no longer held open by the stop 362, the fastener 360 closes as it tends to, and is clamped around the retractable member 226 that passes through it.

The proximal portion of the fastener-ejector 335 can be coupled to the distal end of the moving tube 343, which can be coupled to the trigger 321 at its proximal end. The moving tube 343 can move proximally in response to movement of the trigger 321, and thus the fastener-ejector 335 moves proximally relative to the distal tip 331 of the tool 300 and relative to the fastener 360. As shown in FIG7B, the fastener 360 has been ejected and deployed from the housing 332 of the ejector 335.

In Figure 7D, the fastener-ejector 335 can move further proximally in response to further pulling of the trigger 321 to cut off excess portion of the retractable member 226. The tool 300 can be shaped to define a cutting-promoting edge 370 in its distal end portion 333. For some applications, the cutting-promoting edge 370 defines a sharp edge. As the retractable member 226 passes through the alignment ports 339 and 341 in the distal end portion 333 of the tool 300, as shown in Figures 7A through 7C, the retractable member 226 approaches the cutting-promoting edge 370. Proximally movement of the fastener-ejector 335 causes the cutting-promoting edge 372 of the ejector 335 to abut against the cutting-promoting edge 370 of the tool 300, thereby clamping a portion of the retractable member 226 between edges 370 and 372 to cut and slice the retractable member 226 extending through ports 339 and 341. For some applications, the cutting-promoting edge 372 defines a sharp edge. Figure 7D shows that once the cutting edge 372 of the ejector 335 has abutted against the cutting edge 370 of the tool 300, the retractable member 226 is cut off.

As shown in Figure 7E, once the retractable member 226 is cut off, the tool 300 is pulled out to the proximal side, thereby causing the excess part of the retractable member 226 to be combined with it.

Referring now to Figures 8A through 8D, which are schematic diagrams of an example of a system 510 that uses an annulus remodeling structure 522 (e.g., an annulus remodeling ring structure, closed annulus remodeling structure, closed annulus remodeling ring structure, open annulus remodeling structure, partial annulus remodeling ring structure, etc.) to contract a patient's valve annulus 240, the system may include a housing 530. The housing 530 may accommodate a contraction member fastener 360. Except for the differences described below, the annulus remodeling structure 522 may be the same as or substantially similar to the annulus remodeling structure 222 described above with reference to Figures 1 through 7E, and the same reference numerals denote the same components.

The annular forming structure or annular forming ring structure 522 may include a sleeve 26 that defines a body portion of the structure 522. The structure 522 includes a contraction member 226 having a first portion 526 extending along the longitudinal length of the body portion of the annular forming structure 522. The first portion 526 may extend along the longitudinal length of the structure 522 when the structure 522 is in a linear state and in a bent state, as shown in FIG8A. The contraction member 226 also defines a second portion 524 extending away from the body portion of the annular forming structure 522.

The retractable member 226 may extend through the housing 530 and through a stop 570 (e.g., a retainer) disposed within an opening in the retractable member fastener 360. The stop 570 is shown as cylindrical by way of illustration and not limitation. The outer surface of the stop 570 holds the fastener 360 in the open position. The stop 570 is shaped to define a threaded portion 572, which allows a retractable member receiving tool to be engaged thereto, as described below.

Using the system described above with reference to Figures 1 to 3I, an implanted valve annulus remodeling structure or valve annulus remodeling ring structure 522 is described above with reference to Figures 3A to 3I.

The housing 530 can be attached to the cannula 26 of structure 522 at any suitable location along structure 522. For example, as shown, the housing 530 can be attached to the cannula 26 of structure 522 at a portion of the left fibrous trigone adjacent to the valve of structure 522. For some applications, the housing 530 can be attached to the cannula 26 of structure 522 at a portion of the right fibrous trigone adjacent to the valve of structure 522. For some applications, the housing 530 can be attached to the cannula 26 of structure 522 at a middle portion of structure 522. As shown, the housing 530 can be attached to a side surface of the cannula 26. In such applications, the housing 530 does not obstruct the lumen of the cannula 26 of structure 522.

Figure 8B shows a retractable member receiving tool 600 through which the retractable member 226 has been threaded. The retractable member 226 can be caught by the tool 600 using a snare as described above with reference to Figures 4A to 5D regarding the snare 350. The tool 600 can be advanced along the retractable member 226 toward the housing 530 of structure 522 in a manner similar to that of the tool 300 advancing along the retractable member 226, as described above with reference to Figures 4A to 5D.

Tool 600 may include a distal tip 631 and a distal end portion 633 generally similar to the distal end portion 533 of tool 300 described above with reference to Figures 4A to 7E, and the same reference numerals denote the same components. Because the annular forming structure 522 includes a shrinkage member fastener 360 and a stop 570 removably coupled to the fastener 360, the distal end portion 633 of tool 600 differs from the distal end portion 533 of tool 300 of Figures 4A to 7E, and the remainder of tool 600 corresponds to the remainder of tool 300.

Once the tool 600 is threaded along the retractable member 226, the retractable member 226 extends from the sleeve 26, passes through the stop 570, through the stop-coupler 672 of the tool 600, through the distal tip 631, and then through the alignment ports 339 and 341 of the distal end portion 633 of the tool 600.

The stop-connector 672 of tool 600 is screwed into and engages the threaded portion 572 of stop 570, which is connected to the shrink member fastener 360 disposed within the housing 530 of structure 522.

As described above with reference to Figures 6A and 6B, the retractable member receiving device of tool 600 (not shown, but similar to the retractable member receiving device 322 of tool 300) can be used to retract the retractable member 226. Once the retractable member 226 has retracted and structure 522 has retracted, as shown in Figure 8C, tool 600 removes the stop 570 by pulling the stop 570 proximally away from the fastener 360. Since the fastener 360 tends to close, in the absence of the stop 570, the fastener 360 closes and clamps around the retractable member 226 passing through the fastener 360. In this way, structure 522 is locked by the fastener 360 and remains in the retracted state.

Figure 8D shows the retraction member 226 being cut off near the fastener 360, and the excess portion of the retraction member 226 being removed from the patient's body using tool 600. The cutting of the retraction member 226 is performed with necessary modifications as described above with reference to Figures 7A to 7E.

Referring now to Figures 9A to 9D, which are schematic diagrams of an exemplary shrink member receiving tool 600 for locking and securing the valve ring forming structure 522 of Figures 8A to 8D in its contracted state and subsequently cutting off excess portions of the shrink member 226.

Figure 9A shows the valve ring forming structure 522 in a partially contracted state. The contraction member 226 can be threaded along the sleeve 26 and exit from a portion of the sleeve 26 of the structure 222. As described above, the contraction member 226 can be threaded through the tool 600 in such a way that the member 226 passes through the stop-connector 672 of the tool 600, through the distal tip 631, through the alignment ports 339 and 341 in the distal end portion 633 of the tool 600, and through the sub-tube 340.

In Figure 9B, the contraction member 226 is tensioned, and the annular forming structure 522 is contracted and in a tensioned, contracted state. The distal end portion 633 of the tool 300 is brought close to the annular forming structure 522 (e.g., the tip 631 contacts or is brought close to the housing 530, as shown) to pop out and deploy the fastener 360 within the housing 530 to lock the structure 522 in the contracted state.

Once the distal end portion 633 approaches the sleeve 26, a trigger on the shank portion of the tool 600 (similar to trigger 321 of the tool 300 shown in FIG. 6B) can be partially pulled to allow the retractable member fastener 360 to eject and deploy distally within the housing 530 of the annular forming structure 522. A fastener-ejector 335 is movable within the distal end portion 633 of the retractable member receiving tool 600. Movement of the fastener-ejector 335 transitions the retractable member fastener 360 (e.g., its clamping structure) from its open state to its closed state to clamp onto the retractable member 226 passing through it. Fastener-ejector 335 is connected to stop-coupler 672 of tool 600, which screws into and engages the threaded portion 572 of stop 570 in such a way that when ejector 335 moves proximally within portion 633 of tool 600, stop 570 is pulled away from and separated from fastener 630. Once the retractable member fastener 360 is no longer held open by stop 570, fastener 360 closes as it tends to and is clamped around the retractable member 226 passing through it.

In Figure 9C, the fastener-ejector 335 can be further moved proximally (in response to a further pull of the trigger on the shank portion of the tool 600) to cut off excess portion of the retractable member 226. The tool 600 can be shaped to define a cutting-promoting edge 370 in the distal end portion 633 of the tool 600. For some applications, the cutting-promoting edge 370 defines a sharp edge. As the retractable member 226 passes through the alignment ports 339 and 341 in the distal end portion 633 of the tool 600, the retractable member 226 approaches the cutting-promoting edge 370, as shown in Figure 9B. The proximally moving fastener-ejector 335 causes the cutting-promoting edge 372 of the ejector 335 to abut against the cutting-promoting edge 370 of the tool 300, thereby clamping a portion of the retractable member 226 between edges 370 and 372 to cut and slice the retractable member 226 extending through ports 339 and 341. For some applications, the cutting-promoting edge 372 defines a sharp edge. Figure 9C shows that once the cutting edge 372 of the ejector 335 has abutted against the cutting edge 370 of the tool 600, the retractable member 226 is cut off.

As shown in Figure 9D, once the retractable member 226 is cut off, the tool 600 is pulled out to the proximal side, thereby causing the excess part of the retractable member 226 to be combined with it.

Referring now to Figures 8A through 9D, system 510 provides a valve annulus forming structure 522 (e.g., a valve annulus forming ring structure, a closed valve annulus forming structure, an open valve annulus forming structure, a partial valve annulus forming ring structure, etc.), wherein the housing 530 accommodates the contraction member fastener 360, rather than the fastener 360 being disposed outside the sleeve 26. In this way, system 510 reduces the possibility of embolism and/or condensation.

Referring now to Figures 4A through 9D. The shrink member receiving tools 300 and 600 can be used to (1) apply tension to the shrink member, (2) deploy a lock to ensure the tension of the shrink member, and (3) subsequently cut and sever the shrink member of any valve ring forming structure (e.g., a complete valve ring forming ring structure, a partial valve ring forming ring structure, etc.).

Referring again to Figures 8A through 8D and Figures 9A through 9D. It should be noted that although the tool 600 is described as being advanceable toward the housing 530 already attached to the annulus remodeling structure 522, this scope includes the tool 600 being attached to the housing 530 from a site outside the patient's body and configured to deliver the housing 530 along the constriction member 226 to the cannula 26 of the structure 522 already implanted at the annulus. For this application, the housing 530 is configured to be positioned against the main body portion of the structure 522.

Referring now to Figures 10A and 10B, which are schematic diagrams of an exemplary system 700 including an exemplary retractable member receiving tool 702 configured to retract a retractable member 226 and cut off any excess portion of the retractable member 226.

Apart from the differences described below, the shrink member receiving tool 702 may be the same as or substantially similar to the shrink member receiving tools 300 and 600 described above with reference to Figures 4A to 9D, which are used for (1) applying tension to the shrink member, (2) deploying a lock to secure the tension of the shrink member, and (3) subsequently cutting and severing any valve ring forming structure, such as a complete (or closed) valve ring forming ring structure or a partially (or open) valve ring forming ring structure, of the shrink member.

An exemplary retractable member receiving tool 702 can be used to receive the retractable member 226 of the annulus reshaping structure 730. The annulus reshaping structure 730 may be the same as or substantially similar to the annulus reshaping structures 222 or 522 described above with reference to Figures 1 to 9D, and the same reference numerals denote the same components. At this stage, the annulus reshaping structure 730 (e.g., annulus reshaping ring structure, closed annulus reshaping structure, closed annulus reshaping ring structure, open annulus reshaping structure, partial annulus reshaping ring structure, etc.) has been implanted along the annulus, as described above with reference to Figures 3A to 3I. Once the structure 730 has been implanted along the annulus, the retractable member 226 extends away from the structure 730 and through the patient's vascular system, such that the proximal end portion of the member 226 is disposed outside the patient's body.

Except for the differences described below, the annular forming structure 730 may be the same as or substantially similar to the annular forming structures 222 and 522 described above with reference to Figures 1 to 9D, and the same reference numerals denote the same parts. The annular forming structure 730 may be a complete (or closed) or partial (or open) annular forming structure.

As shown in the figure, structure 730 includes a sleeve 26 defining a main body portion of structure 730. A contraction member 226 has a first portion 732 extending longitudinally along the main body portion of the annular forming structure 730. The contraction member 226 also defines a second portion 734 extending away from the main body portion of the annular forming structure 730.

Although tool 702 is used to implant a complete (or closed) annulusoplasty structure 730, as shown in the figure, the annulusoplasty structure can be an annulusoplasty ring structure and can include a partial (or open) annulusoplasty structure.

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

Tool 702 can be constructed in various ways. In some applications, tool 702 includes an elongated sheath 310. In some applications, sheath 310 encloses a main tube 330 and a secondary tube 340 arranged side-by-side with the main tube 330. For such applications, sheath 310 is shaped to define the secondary tube 340. The secondary tube 340 is shaped to define a longitudinal slit 740. Slit 740 facilitates easy connection and engagement of the contraction member 226 within the lumen of tube 340. Slit 740 also facilitates easy release of the contraction member 226 from the lumen of tube 340. For some applications, slit 740 facilitates easy connection and/or release of the contraction member snare as described above with reference to Figures 4A and 4B. For some applications, the distal portion of the slit 740 is located in a longitudinal position along the tube 340 near the distal end of the tube 340, for example, in a portion of the tube 340 configured to be close to the ventricle placement of the patient's heart, thereby preventing blood from leaking from the heart through the slit 740.

Tool 702 is used to deploy one or more (e.g., two as shown in the figure) 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 through 9D. Using two fasteners 360a and 360b provides redundancy and a more secure fastening around the periphery of structure 730 after shrinkage. Fasteners 360a and 360b can be coaxially positioned around a portion of shrink member 226.

For some applications, a push tube (not shown) is used to deploy the retractable member fasteners 360a and 360b. The push tube includes a semi-rigid material for deployment by pushing the fasteners 360a and 360b. The fasteners 360a and 360b may be coaxially positioned around a portion of the retractable member 226 and located away from the distal end of the push tube. For some applications, the fasteners 360a and 360b are removably positioned around a portion of the push tube.

After fasteners 360A and 360b are deployed, tool 702 is used to cut off any excess portion of the shrink member 226 as described below with reference to tools 300 and 600 in Figures 4A through 9D.

For some applications, the outer sheath 710 is not used, and the tool 702 is connected to the valve ring forming structure using male and female connectors, as shown below with reference to Figures 12, 13 and 15.

Referring now to Figures 11A to 11C, which are schematic diagrams of an exemplary system 800 according to some applications, the system includes an exemplary shrink member receiving tool 810 for locking and securing the valve ring forming structure 222 in its shrunken state, and then cutting off excess portions of the shrink member 226.

Apart from the differences described below, the shrink member receiving tool 810 may be the same as or substantially similar to the shrink member receiving tools 300 and 600 described above with reference to Figures 4A to 9D, which are used for (1) applying tension to the shrink member, (2) deploying a lock to secure the tension of the shrink member, and (3) subsequently cutting and severing any valve ring forming structure such as a complete (or closed) valve ring forming ring structure, a partial (or open) valve ring forming structure, etc.

Figure 11A shows the valve ring forming structure or valve ring forming ring structure 222 in its non-contracted state. The distal tip 331 of the tool 810 can be close to the structure 222. The contraction member 226 can be threaded along the sleeve 26 and exit from a portion of the sleeve 26 of the structure 222. As described above, the contraction member 226 can be threaded through the tool 810 in such a way that the member 226 passes through the distal tip 331, through the contraction member fastener 360 which can be held in the open state, for example by the tip 337 of the stop 362, through the alignment ports 339 and 341 in the distal end portion 333 of the tool 810, and through the sub-tube 340. For some applications, the distal end portion of the tool 810 is similar to the distal end portion of the tool 702 described above with reference to Figures 10A to 10B. For some applications, the distal end portion of the tool 810 is similar to the distal end portion of the tool 920 shown below with reference to Figures 12, 13, and 15. For this application, tool 920 includes male connector 925, and the valve ring forming structure 222 includes a housing 930 shaped to define female connector 927.

Tool 810 includes a proximal handle portion 820. The handle portion 820 includes a proximal contraction amplification knob 830. Knob 830 is fixedly coupled to the proximal end 832 of the contraction member 226. Rotation of the contraction amplification knob 830, as shown in FIG11A, moves the knob 830 proximally. When the knob 830 is pulled proximally, the contraction member 226 is pulled proximally. In response, the annular forming structure 222 contracts. Tool 810 includes a meter 834 that indicates the level of contraction of the annulus in response to the number of rotations of the knob 830.

As shown in Figure 11B, once the distal tip 331 of the tool 810 contacts the sleeve 26 of the structure 222 (or, for some applications, the housing of a lobed annular structure, as described above with reference to Figures 12, 13, and 15), the tool 810 can be used to pull the retractable member 226 by means of rotation of the knob 830, thereby retracting the structure 222, as described above with reference to Figure 11A. During the retraction of the structure 222, the fastener 360 is not deployed.

In Figure 11C, the contraction member 226 is tensioned, and the annular forming structure 222 is contracted and in a tensioned, contracted state. Then, the distal end portion 333 of the tool 810 is used to eject and deploy the fastener 360 from within the tool 810 to lock the structure 222 in the contracted state.

In some applications, once the distal tip 331 contacts the sleeve 26, the trigger knob 840 at the handle portion 820 of the tool 810 is partially pulled to eject and deploy the retractable 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 retractable member receiving tool 810. The proximal portion of the ejector 335 is coupled to the distal portion of the actuation wire 842. The proximal end 844 of the actuation wire 842 is coupled to the trigger knob 840. Proximal movement of the trigger knob 840 pulls the actuation wire 842 proximally, which in turn maximizes the tension of the fastener-ejector 335. Proximal movement of the fastener-ejector 335 transitions the retractable member fastener 360 from its open state to its closed state to clamp onto the retractable member 226 passing through it. Fastener-ejector 335 is coupled to the tip 337 of stop 362 in such a way that as ejector 335 moves proximally within portion 333, stop 362 separates from retractor fastener 360 as tip 337 moves proximally away from retractor fastener 360. Once retractor fastener 360 is no longer held open by stop 362, fastener 360 closes as it tends to and is clamped around retractor 226 passing through it.

The actuation wire 842 is disposed within an inner sheath 841 that extends along the length of an elongated sheath 310. For this application, as shown in Figures 11A to 11C, the elongated sheath 310 includes a multi-cavity sheath that defines (1) a first cavity through which the inner sheath 841 for receiving the actuation wire 842 passes, and (2) a second cavity through which the retraction member 226 passes.

As shown in Figure 11C, the fastener 360 has been ejected and deployed from the housing 332 of the ejector 335. Subsequently, in response to a further proximal pull on the trigger knob 840, the fastener-ejector 335 moves further proximal to cut off the excess portion of the retractable member 226. Similar to tools 300 and 600 described above, tool 810 is shaped to define a cutting-promoting edge 370 in the distal end portion 333 of tool 810. For some applications, the cutting-promoting edge 370 defines a sharp edge. As the retractable member 226 passes through the alignment ports 339 and 341 in the distal end portion 333 of tool 810, as shown in Figures 11A to 11C, the retractable member 226 approaches the cutting-promoting edge 370. The proximal movement of the fastener-ejector 335 causes the cutting-promoting edge 372 of the ejector 335 to abut against the cutting-promoting edge 370 of the tool 810, thereby clamping a portion of the retractable member 226 between edges 370 and 372 to cut and sever the retractable member 226 extending through ports 339 and 341. For some applications, the cutting-promoting edge 372 defines a sharp edge. Figure 11C shows that the retractable member 226 is severed once the cutting-promoting edge 372 of the ejector 335 has abutted against the cutting-promoting edge 370 of the tool 300.

After cutting the constriction member 226, the tool is removed from the patient's body by pulling the tool 810 proximally, causing the excess portion of the constriction member 226 to attach to it.

Now refer to Figures 11A to 11C. For some applications, the trigger knob 840 is coupled to a safety mechanism to prevent unintentional deployment of the fastener 360.

Referring now to Figures 12A to 12C, which are schematic diagrams of an example of a system 900 including an exemplary annulus shaping structure 910 (e.g., an annulus shaping ring structure, a closed annulus shaping structure, an open annulus shaping structure, a partial annulus shaping ring structure, etc.), the annulus shaping structure including a sleeve 26, a retraction member 226, and a lock 950. The implantable annulus shaping structure 910 includes a body portion 912. The retraction member 226 has a first portion 914 extending along the longitudinal length of the body portion 912 of the annulus shaping structure 910, and a second portion 916 extending away from the body portion 912 of the annulus shaping structure 910. The retraction member 226 is configured to adjust the periphery of the annulus shaping structure 910.

Except for the differences described below, the annular forming structure 910 may be the same as or substantially similar to the annular forming structures 222, 522 and 730 described above with reference to Figures 1 to 11C, and the same reference numerals denote the same parts. The annular forming structure 910 may be a complete (or closed) or partial (or open) annular forming structure.

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

The recess 960 is formed into a recessed cavity 962. The recessed cavity 962 is provided along the recessed axis 940.

For some applications, the body portion 912 includes a housing 930 coupled to the sleeve 26. In such applications, the housing 930 defines at least a portion of the sidewall, and the housing 930 defines a recess 960. The sleeve 26 defines the remainder of the sidewall.

For some applications, structure 910 does not include housing 930, and sleeve 26 defines the sidewalls.

A recess 960 is shaped to receive a lock 950. The dimensions of the recess 960 are set such that the lock 950 is compressed when it is at least partially disposed within the recess 960. The lock 950 is shaped to define a series of tapered segments 951. Each segment 951 has a maximum length L1 of 0.2 mm to 1.5 mm. The nearest side portion of the lock 950 has a length L2 of 0.2 mm 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, such that the wall defining the recess 960 compresses the lock when the lock 950 slides into the recess 960. That is, the portion of the longest length L1 of the receiving segment 951 of the recess 960 has a maximum length L3 of 0.2 mm to 1.5 mm. The nearest side portion of the recess 960 has a length L4 of 0.2 mm to 2 mm.

Lock 950 is shaped to define a locking cavity configured to surround contraction member 226. Lock 950 is shaped to define a longitudinal slit 952 extending from the proximal surface of lock 950 toward the distal surface of lock 950. For some applications, slit 952 defines the locking cavity of lock 950. Slit 952 allows lock 950 to be squeezed into a smaller recess 960 and thereby compressed. When lock 950 is compressed, slit 952 allows lock 950 to close around contraction member 226 and thus lock lock 950 to contraction member 226.

For some applications (not shown), the locking lumen has a consistent dimension (e.g., diameter) along the length of the locking lumen from the proximal surface of the lock 950 to the distal surface of the lock 950.

As shown in the figure, for some applications, the locking cavity is shaped to define a distal portion that is wider than the proximal portion of the locking cavity. For such applications, the proximal portion of the recess 960 is narrower than any other portion of the recess 960 that is farther from the proximal portion.

Delivery tool 920 is used to deliver lock 950 to recess 960. Except for the differences described below, delivery tool 920 may be the same as or substantially similar to tools 300, 600, 702, and 810 described above with reference to Figures 4A to 11C, and the same reference numerals denote the same parts. Tool 920 includes a shrink-fit member cutting portion 921, which may include elements of tools 300, 600, 702, and 810 described above with respect to cutting elements.

As shown in Figure 12A, the delivery tool 920 delivers the annulus forming structure or the annulus forming structure 910 and the lock 950 together toward the annulus. The delivery tool 920 and the contraction member 226 are slidable relative to each other. When the delivery tool 920 is engaged with the annulus forming structure 910, a portion of the contraction member 226 (e.g., a second portion 916) is disposed within the lumen of the delivery tool 920, and the lock 950 surrounds a portion of the contraction member. When the delivery tool 920 is engaged with the annulus forming structure 910, the lock 950 is fully disposed proximal to the recess 960.

Figure 12B shows a partial position of the lock 950 within the proximal portion of the recess 960. During partial positioning of the lock 950, the distal portion of the lock 950 is compressed (e.g., the distal tapered section 951). Because the distal portion of the lock cavity of the lock 950 is wider than the proximal portion, when the distal portion of the lock 950 is compressed within the proximal portion of the recess 960, the distal portion of the lock 950 does not completely close around the contraction member 226, such that at this stage, the lock 950 is not locked relative to the contraction member 226, which will pull the contraction member distally as the lock 950 is further advanced distally within the recess 960. Only when the lock 950 is fully pushed into the recess 960, because the nearest portion of the recess 960 is narrower than any other portion of the recess 960 further from the nearest portion, and because the lock cavity of the lock 950 is constricted at the proximal portion 953 of the lock 950, at least the proximal portion 953 of the lock 950 closes around the contraction member 226 to lock the lock 950 to the contraction member, and thereby retains the periphery of the flap-shaped structure 910. That is, the tool 920 often uses a lock ejector 923, similar to the fastener ejector 335 described above, to push the lock 950. The lock ejector 923 is movable within the distal end portion of the tool 920. The movement of the lock ejector 923 contacts the lock 950 and changes the lock from an open state (as shown in FIG12A) to a closed state (as shown in FIG12C) to clamp the lock 950 onto the contraction member 226 passing therethrough.

As shown in Figure 12C, the lock 950 is shaped to fully fit within the recess 960. As described above with reference to tools 300, 600, 702, and 810 in Figures 4A to 11C, tool 920 is configured to cut off any excess portion of the retractable member 226 after the lock 950 has been locked into the retractable member 226 by positioning within the recess 960. That is, the distal end portion of tool 920 is shaped to define a sharp edge, similar to edge 370 of tool 300 described above. Furthermore, as described above, the retractable member 226 is positioned close to the sharp edge, such that the movement of the lock ejector 923 against the sharp edge cuts through the retractable member 226 extending through the lock 950.

Referring now to Figures 13A to 13C, which are schematic diagrams of an example of a system 1000 including an exemplary annulus forming structure or annulus forming structure 910 (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.), the annulus forming structure including a sleeve 26, a contraction member 226, and a lock 1950. Except for the differences described below, system 1000 is the same as or substantially similar to system 900 described above with reference to Figures 12A to 12C, except that when the delivery tool 920 is engaged with the annulus forming structure 910, the lock 1950 is at least partially disposed and retained within the recess 1960. As shown, the distal tapered section 951 is disposed within the proximal portion of the recess 1960. In this way, system 1000 reduces the likelihood of embolism and/or coagulation.

Referring now to Figures 10A through 13C. In Figure 10A, tool 702 includes an outer sheath 710 located at least at the distal portion of tool 702. The outer sheath 710 includes a gripper 720 configured to surround at least a portion of a lobed ring-shaped structure coupled to tool 702. For some applications, any of the tools 300, 600, and 810 described herein includes an outer sheath 710 that includes the gripper 720. The gripper 720 and the outer sheath 710 are configured to provide a reaction force to the lobed ring-shaped structure during deployment of the fastener 360 and/or lock 950, as the fastener 360 and/or lock 950 are pushed by the tool to deploy them. For some applications, the tools described herein do not include the gripper 720.

Referring now to FIG. 14, which is a schematic diagram of an exemplary system 1100 according to some applications, the system includes a lock 1110 configured to lock the periphery of a valve ring forming structure (e.g., a valve ring forming ring structure, a closed valve ring forming structure, an open valve ring forming structure, a partial valve ring forming ring structure, etc.). Except for the differences described below, lock 1110 may be generally similar to lock 950 described above with reference to FIGS. 12A to 13C, and the same reference numerals denote the same components. The slit 952 of lock 1110 is uniform along the longitudinal axis of lock 1110 from the proximal end to the distal end of lock 1110. For some applications, as shown in FIGS. 12A to 13C, the lock cavity is uniform. For some applications, as shown in FIGS. 15A to 15C, the lock cavity is narrower at the proximal end portion of the lock and wider at the distal end portion.

Lock 1110 can be used to lock any of the annulus forming structures described herein, for example, lock 1110 can be used to lock any of the annulus forming structures 222, 522, 730 and 910 described above with reference to Figures 1 to 13C.

A delivery tool can be used to deliver lock 1110 toward a lobed ring forming structure or a lobed ring forming ring structure. This delivery tool may be the same as or substantially similar to tools 300, 600, 702, 810, and 920 described above with reference to Figures 4A to 13C, and the same reference numerals denote the same parts. The delivery tool includes a shrinkage member cut-off portion, which may include elements of tools 300, 600, 702, 810, and 920 described above with respect to the cutting element.

Referring now to Figures 15A through 15C, which are schematic diagrams of an exemplary system 1480 according to some applications, including an exemplary valve ring forming structure 910 (e.g., a valve ring forming ring structure, a closed valve ring forming structure, an open valve ring forming structure, a partial valve ring forming ring structure, etc.), the valve ring forming structure including a sleeve 26, a contraction member 226, and a lock 1490. Except for the differences described below, system 1480 is the same as or substantially similar to system 1000 described above with reference to Figures 13A through 13C, except that lock 1490 has a lumen that is narrower at the proximal end portion of lock 1490 and wider at the distal end portion of lock 1490. Section A-A of Figure 15A shows that the locking lumen around contraction member 226 at the proximal end portion of lock 1490 is wider than the locking lumen around contraction member 226 at the distal end portion of lock 1490 shown in section B-B. As shown in Figure 15C, once the lock 1490 is fully positioned within the recess 960, the proximal end portion closes tightly around the contraction member 226, as shown in section C-C, while the distal end portion closes around the contraction member 226, as shown in section D-D, and may not close as tightly as the proximal end portion.

As shown in the figure, the lock 1490 is shaped into a slit 952 that is narrower at the proximal end portion of the lock 1490 and wider at the distal end portion of the lock 1490.

For some applications, as shown in Figure 14, the lock 1490 is shaped to define a slit 952 that is uniform along the length of the lock 1490.

For some applications, when the delivery tool 920 is coupled to the lobular forming structure 910, the lock 1490 is fully positioned on the proximal side of the recess 1960, as shown in Figures 12A to 12C.

Referring now to FIG16, which is a schematic diagram of an example of an exemplary system 1200 including an exemplary annulus shaping structure 1210 (e.g., annulus shaping ring structure, closed annulus shaping structure, closed annulus shaping ring structure, open annulus shaping structure, partial annulus shaping ring structure, etc.), the annulus shaping structure including a sleeve 26, a retraction member 226, and a lock 1220. The implantable annulus shaping structure 1210 includes a body portion. The retraction member 226 has a first portion extending along the longitudinal length of the body portion of the annulus shaping structure 1210 and a second portion extending away from the body portion of the annulus shaping structure 1210. The retraction member 226 is configured to adjust the periphery of the annulus shaping structure 1210.

Except for the differences described below, the annular forming structure 1210 may be the same as or substantially similar to the annular forming structures 222, 522, 730 and 910 described above with reference to Figures 1 to 15C, and the same reference numerals denote the same parts. The annular forming structure 1210 may be a complete (or closed) or partial (or open) annular forming structure.

Structure 1210 includes a housing 1202, which is shaped to define sidewalls and to define a recess 1230 having a recess axis. The recess 1230 extends from an opening in a first surface of the housing toward an opposing second surface of the housing 1202. The housing 1202 is shaped to provide a contraction member cavity wall 1205 disposed along a contraction member cavity 1204. The contraction member cavity 1204 is disposed at a non-zero angle relative to the recess axis 1207 of the recess 1230. The recess 1230 is shaped to define a recess cavity disposed along the recess axis 1207.

Lock 1220 is shaped to define a locking thread portion 1222. The housing 1202 of the annular forming structure 1210 is shaped to define a annular forming structure thread portion 1232 configured to engage with the locking thread portion 1222. To advance lock 1220 within the recess 1230 of housing 1202, the physician uses a delivery tool to screw lock 1220 into housing 1202. This delivery tool may be the same as or substantially similar to tools 300, 600, 702, 810, and 920 described above with reference to Figures 4A through 13C, and the same reference numerals denote the same components. The delivery tool includes a shrink-fit member cut-off portion, which may include elements of tools 300, 600, 702, 810, and 920 described above with respect to cutting elements.

When the lock 1220 is placed in the recess, the distal surface of the distal end of the lock 1220 is configured to press a first portion of the contraction member 226 against the wall 1205 of the contraction member cavity so as to lock the contraction member 226 at least at the first pressing point 1212.

For some applications, housing 1202 defines at least a portion of the sidewall of the lobed annular structure 1210, and housing 1202 defines a recess 1230.

Lock 1220 is shaped to define a locking cavity 1221 configured to surround contraction member 226. Lock 1220 is shaped to define a longitudinal slit extending from a proximal surface of lock 1220 toward a distal surface of lock 1220. For some applications, the slit defines the locking cavity 1221 of lock 1220. The slit allows lock 1220 to be squeezed into a smaller recess 1230 and thereby compressed. When lock 1220 is compressed, the slit allows lock 1220 to close around contraction member 226, and thus locks lock 1220 to contraction member 226.

For some applications, the lock cavity 1221 has a consistent dimension (e.g., diameter) along the length of the lock cavity 1221 from the proximal surface of the lock 1220 to the distal surface of the lock 1220.

Referring now to Figures 15A through 15C and Figure 16. For some applications, the locking cavity 1221 of the lock 1220 is shaped to define a distal portion that is wider than the proximal portion of the locking cavity 1221. For such applications, the proximal portion of the recess 1230 may be narrower than any other portion of the recess 1230 that is farther from the proximal portion.

Referring now to Figures 12A to 12C, 13A to 13C, 15A to 15C, and 16. For some applications, the slit of lock 1220 is wider at the distal end portion of lock 1220 and narrower at the proximal end portion of lock 1220.

Referring now to Figures 14 and 16. For some applications, the slit of lock 1220 is uniform along its length. For some applications, the lock cavity 1221 is uniform along the length of lock 1220.

Referring now to FIG. 17, which is a schematic diagram of an example of an exemplary system 1300 including an exemplary annulus shaping structure 1310 (e.g., annulus shaping ring structure, closed annulus shaping structure, closed annulus shaping ring structure, open annulus shaping structure, partial annulus shaping ring structure, etc.), the annulus shaping structure including a sleeve 26, a retraction member 226, and a lock 1320. The implantable annulus shaping structure 1310 includes a body portion. The retraction member 226 has a first portion extending along the longitudinal length of the body portion of the annulus shaping structure 1310 and a second portion extending away from the body portion of the annulus shaping structure 1310. The retraction member 226 is configured to adjust the periphery of the annulus shaping structure 1310.

Except for the differences described below, the annular forming structure 1310 may be the same as or substantially similar to the annular forming structures 222, 522, 730 and 910 described above with reference to Figures 1 to 15C, and the same reference numerals denote the same parts. The annular forming structure 1310 may be a complete (or closed) or partial (or open) annular forming structure.

Structure 1310 includes a housing 1302, which is shaped to define sidewalls and to define a recess 1330 having a recess axis. The recess 1330 extends from an opening in a first surface of the housing toward an opposing second surface of the housing 1302. The housing 1302 is shaped to provide a contraction member cavity wall 1305 disposed along a contraction member cavity 1304. The contraction member cavity 1304 is disposed at a non-zero angle relative to the recess axis 1307 of the recess 1330. The recess 1330 is shaped to define a recess cavity disposed along the recess axis 1307.

Lock 1320 is shaped to define a locking thread portion 1222. The housing 1302 of the annular forming structure 1310 is shaped to define a annular forming structure thread portion 1332 configured to engage with the locking thread portion 1322. To advance lock 1320 within the recess 1330 of housing 1302, the physician uses a delivery tool to screw lock 1320 into housing 1302. This delivery tool may be the same as or substantially similar to tools 300, 600, 702, 810, and 920 described above with reference to Figures 4A through 13C, and the same reference numerals denote the same components. The delivery tool includes a retractable member cut-off portion, which may include elements of tools 300, 600, 702, 810, and 920 described above with respect to cutting elements.

When the lock 1320 is disposed within the recess, the distal surface of the distal end of the lock 1320 is configured to press a first portion of the contraction member 226 against the wall 1305 of the contraction member cavity, so as to lock the contraction member 226 at least at the first pressing point 1312. The lock 1320 is shaped to define a lock cavity 1321 and a distal tapered portion 1334 along its longitudinal length. The housing 1302 and the recess 1330 are shaped to define the distal tapered portion 1324 of the recess. When the lock 1320 is disposed within the recess 1330 and the lock distal tapering portion 1334 is located within the recess distal tapering portion 1324, the recess distal tapering portion 1324 is configured to compress the lock distal tapering portion 1334, which is further configured to press a second portion of the contraction member 226 within the lock cavity 1321 at the recess distal tapering portion 1324, so as to lock the contraction member 226 at least at the second compression point 1314.

For some applications, housing 1302 defines at least a portion of the sidewall of the lobed annular structure 1310, and housing 1302 defines a recess 1330.

The locking cavity 1321 is configured to surround the contraction 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. For some applications, the slit defines the locking cavity 1321 of the lock 1320. The slit allows the lock 1320 to be squeezed into a smaller recess 1330 and thereby compressed. When the lock 1320 is compressed, the slit allows the lock 1320 to close around the contraction member 226, and thus allows the lock 1320 to lock onto the contraction member 226.

For some applications, the lock cavity 1321 has a consistent dimension (e.g., diameter) along the length of the lock cavity 1321 from the proximal surface of the lock 1320 to the distal surface of the lock 1320.

Referring now to Figures 15A through 15C and Figure 17. For some applications, the locking cavity 1321 of the lock 1320 is shaped to define a distal portion that is wider than the proximal portion of the locking cavity 1321. For such applications, the proximal portion of the recess 1330 may be narrower than any other portion of the recess 1330 that is farther from the proximal portion.

Referring now to Figures 12A to 12C, 13A to 13C, 15A to 15C, and 17. For some applications, the slit of lock 1320 is wider at the distal end portion of lock 1320 and narrower at the proximal end portion of lock 1320.

Referring now to Figures 14 and 17. For some applications, the slit of lock 1320 is uniform along its length. For some applications, the lock cavity 1321 is uniform along the length of lock 1320.

Referring now to Figures 16 and 17, systems 1200 and 1300 provide locking components that allow the operator to readjust the periphery of the annulus angioplasty structure after locking. For example, if the operator wishes to readjust once locks 1220 and 1320 are in place, the operator can release locks 1220 and 1230 respectively to readjust the periphery of the annulus angioplasty structure by loosening or tightening the constriction member 226 without disengaging locks 1220 and 1300 from the corresponding recesses 1230 and 1330. After readjustment of the constriction member 226, locks 1220 and 1320 are repositioned within the corresponding recesses 1230 and 1330.

Referring now to FIG18, which is a schematic diagram of an example of a system 1350 that uses an annulus retraction structure 522 (e.g., an annulus retraction ring structure, closed annulus retraction structure, closed annulus retraction ring structure, open annulus retraction structure, partial annulus retraction ring structure, etc.) to contract a patient's valve annulus 240, the system may include a housing 530. The housing 530 may accommodate a contraction member fastener 1360. Except for the differences described below, the annulus retraction structure 522 may be the same as or substantially similar to the annulus retraction structure 222 described above with reference to FIGS. 1 through 7E, and the same reference numerals denote the same parts.

The annular forming structure or annular forming ring structure 522 may include a sleeve 26 that defines a body portion of the structure 522. The structure 522 includes a contraction member 226 having a first portion extending along a longitudinal length of the body portion of the annular forming structure 522. The contraction member 226 also defines a second portion extending away from the body portion of the annular forming structure 522.

The retractable member 226 may extend through the housing 530 and through a stop 570 (e.g., a retainer) disposed within an opening in the retractable member fastener 1360. The stop 570 is shown as cylindrical by way of illustration and not limitation. The outer surface of the stop 570 holds the fastener 1360 in the open position. The stop 570 is shaped to define a threaded portion that allows the retractable member receiving tool 600 to be engaged thereto, as described above.

Using the system described above with reference to Figures 1 to 3I, an annulus remodeling structure or annulus remodeling ring structure 522 is implanted as described above with reference to Figures 3A to 3I.

The housing 530 can be attached to the cannula 26 of structure 522 at any suitable location along structure 522. For example, as shown, the housing 530 can be attached to the cannula 26 of structure 522 at a portion of the left fibrous trigone adjacent to the valve of structure 522. For some applications, the housing 530 can be attached to the cannula 26 of structure 522 at a portion of the right fibrous trigone adjacent to the valve of structure 522. For some applications, the housing 530 can be attached to the cannula 26 of structure 522 at a middle portion of structure 522. As shown, the housing 530 can be attached to a side surface of the cannula 26. In such applications, the housing 530 does not obstruct the lumen of the cannula 26 of structure 522.

Fastener 1360 is generally similar to fastener 360 of Figures 8A to 8D, except that fastener 1360 is shaped to define intersecting slits 1362 that form an opening through which the contraction member 226 passes into a generally “X” or generally “+” shape.

Figure 18 shows the retraction member 226 being cut off near the fastener 1360, and the excess portion of the retraction member 226 being removed from the patient's body using tool 600. The cutting of the retraction member 226 can be performed with necessary modifications as described above with reference to Figures 7A to 7E.

Referring now to Figures 19A and 19B, which are schematic diagrams of an example of a system 1400 that uses an annulus remodeling structure (e.g., annulus remodeling ring structure, closed annulus remodeling structure, closed annulus remodeling ring structure, open annulus remodeling structure, partial annulus remodeling ring structure, etc.) to contract a patient's valve annulus, the system being coupled to a housing 1430. The housing 1430 may accommodate a contraction member fastener 1460. For some applications, the annulus remodeling structure may be the same as or substantially similar to the annulus remodeling structure 222 described above with reference to Figures 1 through 7E, and the same reference numerals denote the same components. For some applications, the annulus remodeling structure includes the housing 1430. For some applications, the housing 1430 is separate from the annulus remodeling structure and is only delivered and coupled to the annulus remodeling structure once it has been anchored to the valve annulus.

The housing 1430 can be attached to the sleeve 26 of the annular forming structure at any suitable location along the annular forming structure. For example, as shown, the housing 1430 can be attached to the sleeve 26 of the annular forming structure at a portion of the left fibrous triangle adjacent to the valve. For some applications, the housing 1430 can be attached to the sleeve of the annular forming structure at a portion of the right fibrous triangle adjacent to the valve. For some applications, the housing 1430 can be attached to the sleeve of the annular forming structure at a middle portion of the annular forming structure. As shown, the housing 1430 can be attached to a side surface of the sleeve. In such applications, the housing 1430 does not obstruct the lumen of the sleeve of the annular forming structure.

The annular forming structure or annular forming ring structure may include a sleeve that defines a main portion of the structure. The structure includes a contraction member 226 having a first portion extending along a longitudinal length of the main portion of the annular forming structure. The contraction member also defines a second portion extending away from the main portion of the annular forming structure.

Fastener 1460 is shaped to define a generally rectangular, flat clamp comprising a hyperelastic material (e.g., nitinol). Fastener 1460 includes a deformable element shaped to define a plurality of slits surrounded by a plurality of flexible legs 1462, which allow the clamp to transition between an inclined (FIG. 19A) and a straight (FIG. 19B) position. The contraction wire engagement surface of the clamp is shaped to define a plurality of teeth 1464. For some applications, the teeth 1464 are serrated. For some applications, the upper surface of the clamp does not include the teeth 1464 and is flat. The teeth 1464 are configured to increase friction between the contraction member 226 and fastener 1460.

Fastener 1460 includes a clamping structure that is (a) biased toward a closed state (FIG. 19B). In the closed state, the clamping structure is configured to clamp onto a contraction member 226 passing therethrough, and (b) bendable to an open state in which the contraction member 226 is movable through therethrough (FIG. 19A).

The retraction member 226 may extend through a channel 1434 of the housing 1430 and through a stop 1470 (e.g., a retainer) disposed within an opening in the retraction member fastener 1460. The channel 1434 extends along the longitudinal axis 1410 of the housing 1430. The stop 1470 may be shaped to define a lumen therethrough to surround the retraction member 226 and is shown shaped to define a larger cylindrical portion that can be engaged by a tool, and a narrower cylindrical engagement member 1472. The engagement member 1472 may be shaped to fit tightly within the channel 1434 such that it abuts against the retraction wire engagement surface of the clamp and holds the fastener 1460 in an inclined state, i.e., the unlocked state of the fastener 1460. In the inclined state, as shown in FIG19A, the clamp deforms and does not abut against the retraction member 226. In the inclined state, the retraction member 226 is free to move relative to the fastener 1460, the housing 1430, and the stop 1470. The shrinkage member 226 is pulled until it fully shrinks to form the valve ring structure.

In Figure 19B, the stop 1470 has been separated and removed from the housing 1430. Without any force applied to the shrink wire engagement surface of the clamp via the engagement member 1472, the clamp returns to its resting, straight position, and the shrink member 226 is confined between the shrink wire engagement surface of the clamp and the surface 1432 (e.g., the inner wall) of the housing 1430. Thus, the fastener 1460 is now in a locked state, in which the clamp locks and restrains the shrink member 226.

Referring now to Figures 20A to 20F, which are schematic diagrams of an example of a portion of a multi-part tubular system 1500 including a shrink member cutting tool 1502 and a shrink member receiving tool 1600, the following description will be made with reference to Figures 21A to 26B. A shrink member 226 is threaded through and passes through the shrink member cutting tool 1502 and through the shrink member receiving tool 1600. The shrink member 226 can be caught by the tool 1502 using a snare as described above with reference to Figures 4A to 5D regarding the snare 350. The tool 1502 can be advanced along the shrink member 226 toward a valgus ring forming structure 1522 (e.g., a valgus ring forming ring structure, a closed valgus ring forming structure, an open valgus ring forming structure, a partially valgus ring forming ring structure, etc.). For some applications, tool 1502 is advanced toward housing 1530, which is already attached to structure 1522, in a manner similar to that of tool 300 advancing along constriction member 226, as described above with reference to Figures 4A to 5D. The annulus reshaping structure 1522 may include a flexible body portion. Constriction member 226 has a first portion extending along the longitudinal length of the body portion. A second portion of constriction member 226 may extend away from the body portion of annulus reshaping structure 1522 and extend outside the patient's body.

System 1500 is used to shrink a patient's valve annulus using an annulus reshaping structure 1522 (e.g., an annulus reshaping ring structure, closed annulus reshaping structure, closed annulus reshaping ring structure, open annulus reshaping structure, partial annulus reshaping ring structure, etc.). The system may include a housing 1530. Housing 1530 may accommodate a shrinkage member fastener 1560. Except for the differences described below, the annulus reshaping structure 1522 may be the same as or substantially similar to the annulus reshaping structure 222 described above with reference to Figures 1 through 7E, and the same reference numerals denote the same components.

It should be noted that fastener 1560 may include fastener 360 described above with reference to Figures 4A to 4B, Figures 7A to 7E, Figures 8A to 8D, Figures 9A to 9D, Figures 10A to 10B and Figures 11A to 11C, lock 950 described above with reference to Figures 12A to 12C, lock 1950 described above with reference to Figures 12A to 12C, lock 1110 described above with reference to Figure 14, lock 1490 described above with reference to Figures 15A to 15C, lock 1220 described above with reference to Figure 16, lock 1320 described above with reference to Figure 17, or any other fastener, lock and/or restraint known in the art.

The annular forming structure or annular forming ring structure 1522 may include a sleeve 26 that defines a body portion of the structure 1522. The structure 1522 includes a contraction member 226 having a first portion extending along a longitudinal length of the body portion of the annular forming structure 1522. The contraction member 226 also defines a second portion extending away from the body portion of the annular forming structure 1522.

The retractable member 226 may extend through the housing 1530 and through a stop 1570 (e.g., a retainer) disposed within an opening in the retractable member fastener 1560. The stop 1570 is shaped to define a lumen therethrough to surround the retractable member 226 and is shown shaped to define a larger cylindrical portion that can be engaged by a tool, and a narrower cylindrical engagement member 1574. As shown in Figures 20A to 20D, the outer surface of the engagement member 1574 holds the fastener 1560 in an open position. The stop 1570 is shaped to define a cantilever 1572 that allows the retractable member cutting tool 1502 to engage with it, as described below.

Using the system described above with reference to Figures 1 to 3I, an implanted valve annulusification structure or valve annulusification ring structure 1522 is described above with reference to Figures 3A to 3I.

The housing 1530 can be attached to the cannula 26 of structure 1522 at any suitable location along structure 1522. For example, as shown, the housing 1530 can be attached to the cannula 26 of structure 1522 at a portion of the left fibrous trigone adjacent to the valve of structure 1522. For some applications, the housing 1530 can be attached to the cannula 26 of structure 1522 at a portion of the right fibrous trigone adjacent to the valve of structure 1522. For some applications, the housing 1530 can be attached to the cannula 26 of structure 1522 at a middle portion of structure 1522. As shown, the housing 1530 can be attached to a side surface of the cannula 26. In such applications, the housing 1530 does not obstruct the lumen of the cannula 26 of structure 1522.

Figure 20A shows a shrink member cutting tool 1502 through which the shrink member 226 has been threaded. The shrink member 226 can be caught by the tool 1502 using a snare as described above with reference to Figures 4A to 5D regarding the snare 350. The tool 1502 can be advanced along the shrink member 226 toward the housing 1530 of the structure 1522 in a manner similar to that of the tool 300 advancing along the shrink member 226, as described above with reference to Figures 4A to 5D.

Once the tool 1502 is inserted along the retraction member 226, the retraction member 226 extends from the sleeve 26, through the coupling 1574, through the proximal portion of the stop 1570, through the cutting elements 1510 and 1520 of the tool 1502, and through the remaining proximal portion of the tool 1502. Thus, the retraction member 226 is positioned near the cutting elements. The retraction member 226 is positioned along the entire length of the tool 1502 along its longitudinal axis 1511. The relative spatial orientation of the components of the tool 1502 allows the retraction 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 direct and unwinding path reduces friction as the member 226 moves within the tool 1502. This direct path of the contraction member 226 is achieved due to the orientation of the components of tool 1502, which is the opposite of the winding path of member 226 via tools 300, 600, 810, and 920 described above. As described below with reference to Figures 21A to 26B, the reduction of friction on the contraction member 226 reduces noise during tension measurement of the contraction member 226.

Tool 1502 includes an inner tube 1504 slidable relative to an outer sleeve portion 1508. The distal end of the inner tube 1504 is shaped to define a gripper 1505 or fastener-ejector. Because the distal end portion of the tube 1504 is slotted, and because the gripper 1505 is angled, the gripper 1505 tends to be pushed radially outward in the presence of a force applied thereto by the cantilever 1572. Once the tube 1504 is sufficiently pushed distally, the gripper 1505 bypasses the cantilever 1572 distally and bypasses a stop 1570 at a point away from the cantilever 1572, as shown in FIG20B. By gripping the cantilever 1572, the gripper 1505 provides primary and initial engagement and locking of tool 1502 with housing 1530.

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

Once the stop 1570 is engaged by the inner tube 1504, the outer sleeve portion 1508 moves distally along the inner tube 1504 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 FIG20C. This distal movement of portion 1508 locks the tube 1504 in place relative to the stop 1570, and thereby locks the tool 1502 in place relative to the housing 1530. Because the grippers 1505 are inclined, they are able to slide proximally around the overhang 1572 in response to proximal pull of the tool 1502. Therefore, during the release of fastener 1560, the outer sleeve portion 1508 surrounding the slotted distal end portion of tube 1504 and the gripper 1505 surrounding tube 1504 prevent the gripper 1505 from moving radially in response to the proximal tension applied by tool 1502 to stop 1570, so as to lock the contraction member 226 in place and hold the valve ring forming structure 1522 in a tensioned state, as will be described below. Thus, the outer sleeve portion 1508 locks the gripper 1505 relative to the overhang 1572 and provides auxiliary connection and locking of tool 1502 to housing 1530.

The static cutting element 1510 includes a pin 1513 that slides proximally and distally within a slit 1515 of the tube 1404. Thus, the static cutting element 1510 is coupled to the tube 1404 and to the tube surrounding the tube 1404. Specifically, the pin 1513 is coupled to the outer sleeve portion 1508. When the outer sleeve portion 1508 moves distally, as shown in FIG20C, the pin 1513 moves distally within the slit 151, and the static cutting element 1510 and the dynamic cutting element 1520 are pushed distally within the tube 1404. In this state, the distal surface 1523 of the dynamic cutting element 1520 remains positioned at a distance from the proximal surface 1571 of the stop member 1570.

Figure 20D illustrates the shrinking valve ring forming structure 1522 in response to the tool 1502 pulling the shrinking member 226 proximally. During the pulling of the shrinking member 226, the tool 1502 remains engaged to the housing 1530 as the gripper 1505 grips the overhang 1572, while the outer sleeve portion 1508 surrounds the distal portion of the inner tube 1504 and surrounds the gripper 1505.

Tool 1502 may include a retractable member receiving device 322 of tool 300, as described above with reference to Figures 4A to 4B. The retractable member receiving device is used to retract the retractable member 226. Once the retractable member 226 has retracted and structure 1522 has retracted, as shown in Figure 20D, tool 1502 removes the stop 1570 by pulling the stop 1570 proximally away from the fastener 1560, as shown in Figure 20E. While maintaining a distal force on the outer sleeve portion 1508, the tube 1404 is pulled proximally relative to portion 1508. Due to the presence of the outer sleeve portion 1508, the gripper 1505 remains gripped on the overhang 1572 of the stop 1570, thus pulling the stop 1570 proximally towards the tube 1504. During the proximal traction of the tube 1504, the outer sleeve portion 1508 prevents radial outward movement of the gripper 1505 when a proximal force is applied to the tube 1504. The tube 1504 is pulled proximal until the stop 1570 disengages from the housing 1530, i.e., until the engagement portion 1574 of the stop 1570 separates from and disengages from the fastener 1560, as shown in FIG20E. Since the fastener 1560 tends to close, in the absence of the stop 1570, the fastener 1560 closes and clamps around the retractable member 226 passing through the fastener 1560. In this way, the structure 1522 is locked by the fastener 1560 and remains in a retracted state.

When the stop 1570 is pulled proximally, its proximal surface hammers into the distal surface 1523 of the dynamic cutting element 1520. In response to the stop 1570 pushing against the dynamic cutting element 1520, the dynamic cutting element 1520 is pushed proximally, causing it to move diagonally proximally. The cutting surface 1521 of the dynamic cutting element 1520 and the cutting element 1520 slide diagonally proximally along the cutting surface 1512 of the static cutting element 1510. The portion of the shrinkage member 226 disposed between the cutting surfaces 1512 and 1521 is cut off. Because the cutting surfaces 1512 and 1521 are concave and face each other, during cutting, surfaces 1512 and 1521 compress the shrinkage member 226, thereby cleanly and without abrasion cutting off the shrinkage member 226.

Therefore, tool 1502 is arranged such that it advantageously provides a safety mechanism by which the retractable member 226 can only be cut by a proximal force applied thereto by stop 1570 after fastener 1560 has been switched to the tightened or locked state and the retractable member 226 has been locked in place. That is, tool 1502 will not inadvertently cut the retractable member 226 during the entire process of tool 1502 not being engaged with stop 1570 and during the entire process of stop 1570 not pushing against cutting element 1520. In a rapid movement, tool 1502 (1) locks the retractable member 226 in place by switching fastener 1560 to the locked state and (2) cuts the retractable member 226.

Figure 20F shows the retractable member 226 after it has been cut near fastener 1560 and the excess portion of the retractable member 226 has been removed from the patient's body using tool 1502. The entire tool 1502 is pulled proximally to separate it from the housing 1530 and from the structure 1522 that carries the stop 1570 within the lumen of the tool 1502. Since the stop 1570 is no longer attached to the housing 1530, simple proximal pulling on the tool 1502 is sufficient to separate the tool 1502 from the annulus-forming structure 1522.

Referring again to Figures 20A through 20F, it should be noted that although the tool 1502 is described as being advanceable toward the housing 1530 already attached to the annulus remodeling structure 1522, this scope includes the tool 1502 being attached to the housing 1530 from a site outside the patient's body and configured to deliver the housing 1530 along the constriction member 226 to the cannula 26 of the structure 1522 already implanted at the annulus. For this application, the housing 1530 is configured to be positioned against the main body portion of the structure 1522.

Referring now to Figures 21A through 26B, which are schematic diagrams of another part of a multi-component tubular system 1500 according to some applications, described above with reference to Figures 20A through 20F, it includes a retractable member receiving tool 1600 configured to retract the flexible elongated retractable member 226. Figures 21A and 21B show the retractable member receiving tool 1600 before the flexible elongated retractable member 226 is inserted, and Figures 22A through 26B show the retractable member receiving tool 1600 after the flexible elongated retractable member 226 is inserted.

The multi-component tubular system 1500 is used with an implant comprising an implantable structure and a flexible, elongated, retractable member 226 extending away from the implantable structure. The implant may include any implant described herein, such as an implantable annular shaping structure 222, which may, for example, include a flexible cannula 26. Alternatively, the implant may include another type of implant known in the art (including those described in the patent and patent application publications incorporated herein by reference) that may or may not include a cannula.

The retractable member receiving tool 1600 includes a handle portion 1620, which is optionally supported by a bracket, as described above with reference to Figures 1 and 2. The handle portion 1620 may include one, some, or all of the following:

• Outer housing 1632, which can be ergonomically shaped for use by a user (e.g., physician, healthcare professional, etc.);

• A tubular shaft 1634, which is at least partially disposed within the outer housing 1632;

• Inner shaft 1636, which (a) is partially disposed within the proximal longitudinal portion 1637 of the tubular shaft 1634 such that the inner shaft 1636 is axially slidable relative to the tubular shaft 1634, and (b) is shaped to define an inner shaft retraction member receiving channel 1638;

• A distal force applicator 1642, which (a) is at least partially disposed within the distal longitudinal portion of the tubular shaft 1634, and (b) is shaped to define a distal force applicator retraction member receiving channel 1644, which allows the retraction member 226 to slide through it;

• Spring 1646, which is disposed within the tubular shaft 1634, connecting the distal force applicator 1642 and the distal portion 1647 of the inner shaft 1636; and

• A contraction-promoting knob 1630, which can be accessed from the outside of the outer housing 1632.

The handle portion 1620 is shaped to define a handle retractor receiving channel 1650 extending from the distal end of the handle portion 1620 to the proximal end (as used in the claims included herein, "proximal" means towards the user, i.e., away from the implant; referring to Figures 21A to 26B, "proximal" means to the right in the figures). The handle retractor receiving channel 1650 includes an inner-axis retractor receiving channel 1638, a distal force applicator retractor receiving channel 1644, and optional additional retractor receiving channels of the handle portion 1620. After or before the implantable structure and the retractor 226 are advanced toward the patient's heart, a portion of the retractor 226 passes through the handle retractor receiving channel 1650.

The inner shaft 1636 may include a lock 1640 configured to (i) allow the retractable member 226 to slide relative to the inner shaft retractable member receiving channel 1638 when in an unlocked state, and (ii) axially lock the retractable member 226 relative to the inner shaft 1636 when in a locked state. Optionally, the lock 1640 applies friction to axially lock the retractable member 226 relative to the inner shaft 1636, such as using a set of screws or levers, as known in the art.

The handle portion 1620 is configured such that when the retractable member 226 is fully inserted through the handle retractable member receiving channel 1650 and the lock 1640 is in the locked state, actuating the retraction actuation knob 1630 causes the handle portion 1620 to receive a continuous portion of the retractable member 226. Figures 22A and 22B show the handle portion 1620 before actuating the retraction actuation knob 1630 when the retractable member 226 is fully inserted through the handle retractable member receiving channel 1650 and the lock 1640 is in the locked state. Figures 23A to 23B, 24A to 24B, and 25A to 25B show the handle portion 1620 after successive actuation levels of the retraction actuation knob 1630, as described below.

As shown in Figures 21A-21B and 22A-22B, prior to the initial actuation of the contraction actuation knob 1630, the portion of the contraction member 226 between the handle portion 1620 and the implant may be slightly relaxed or at most minimally tensioned. The proximal ends 1652 of the tubular shaft 1634 and 1654 of the inner shaft 1636 are positioned at an initial offset distance D1 between them, indicating that there is essentially no tension in the contraction member 226, i.e., the contraction member 226 is not tensioned. In applications where the implant includes an implantable annulus reshaping structure 222, which includes a flexible cannula 26 (attached to the annulus 240) is in a relaxed, untensioned state. At this point, the tool has been sufficiently advanced through the patient's vascular system, such that the distal tip of the tool approaches the structure 222 positioned along the annulus.

For example, as shown in the figure, during the transition between Figures 22A to 22B and Figures 23A to 23B, actuation of the retraction actuation knob 1630 causes the handle portion 1620 to accommodate a continuous portion of the retraction member 226 in the following manner:

This causes the tubular shaft 1634 to advance proximally relative to the outer housing 1632.

This allows the distal force applicator 1642 to advance proximally relative to the outer housing 1632 (during normal use of the handle portion 1620, the distal force applicator 1642 can be axially fixed to the tubular shaft 1634).

It applies a proximal guiding force to spring 1646.

It pushes the inner shaft 1636 proximally relative to the outer housing 1632 (by applying a proximally guiding force to the inner shaft 1636 via spring 1646),

Its proximal pull contraction member 226 (which is axially locked to the inner shaft 1636 by lock 1640, as described above).

Sometimes, 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 and 22B and Figures 23A and 23B, the contraction member 226 is relatively relaxed, as described above, such that the inner shaft 1636 provides little or no resistance to the proximal guiding force applied to it by the spring 1646, and the spring 1646 is not axially compressed or is only minimally compressed axially. Therefore, the proximal advancement of the inner shaft 1636 relative to the outer housing 1632 is the same as or substantially the same as the proximal advancement of the tubular shaft 1634 relative to the outer housing 1632, and the offset distance remains at its initial value (D1), indicating that there is essentially no tension in the contraction member 226. This initial proximal advancement of the tubular shaft 1634 and the inner shaft 1636 relative to the outer housing 1632 is used to accommodate different initial degrees of relaxation in the contraction member 226.

As the distal force applicator 1642 advances proximally relative to the outer housing 1632 a certain distance, the contraction member 226 becomes tensioned (at an initial low tension level), causing the inner shaft 1636 to gradually provide increased resistance to the proximally guided force applied to the inner shaft 1636 by the spring 1646, and the spring 1646 gradually becomes more compressed. As used herein, including in the claims, the contraction member 226 is considered "tensioned," even when tensioned at a low level.

As shown in the transition between Figures 23A and 23B and Figures 24A and 24B, as the spring 1646 is further compressed, the distal force applicator 1642 moves axially closer to the inner shaft 1636, causing the tubular shaft 1634 to move proximally relative to the inner shaft 1636. Therefore, the spring 1646 pushes the inner shaft 1636 proximally relative to the outer housing 1632 to a lesser extent than the tubular shaft 1634 is pushed proximally relative to the outer housing 1632, and the tension in the contraction member 226 is increased by the proximally pulling contraction member 226 by the inner shaft 1636. Consequently, the offset distance between the proximal end 1652 of the tubular shaft 1634 and the proximal end 1654 of the inner shaft 1636 decreases to a tension offset distance D2, as shown in Figures 24A and 24B (in actual use of the handle, many tension offset distances D2 occur; a single offset is shown for illustrative purposes). The tension offset distance D2 is less than the initial offset distance D1, which reflects the fact that the portion of the inner shaft 1636 protruding from the proximal end 1652 of the tubular shaft 1634 has been reduced.

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

For some applications, the tubular shaft 1634 and the contraction actuation knob 1630 are threaded together, and the shank portion 1620 is configured such that actuation of the contraction actuation knob 1630 rotates the tubular shaft 1634, thereby advancing the tubular shaft 1634 proximally relative to the outer housing 1632. For some of these applications, the contraction actuation knob 1630 is configured to be actuated by its rotation (e.g., about the central longitudinal axis of the tubular shaft 1634), as shown in the figures.

For some applications, the handle portion 1620 also includes an inner stabilizing tube 1680, which (a) extends proximally from and is axially fixed to the distal force applicator 1642, and (b) defines a portion of a handle retraction member receiving channel 1650 passing through it. A portion of the inner stabilizing tube 1680 is disposed within the inner shaft retraction member receiving channel 1638; the length of this portion 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 be freely axially movable relative to the outer surface of the inner stabilizing tube 1680.

For some applications, the inner shaft 1636 protrudes partially beyond the proximal end 1639 of the outer housing 1632, making a portion of the inner shaft 1636 visible to the user. For these applications, the tubular shaft 1634 and the inner shaft 1636 together provide a non-electromechanical force gauge 1624, wherein the relative axial position of the tubular shaft 1634 relative to the inner shaft 1636 (i.e., the offset distance D between the proximal end 1652 of the tubular shaft 1634 and the proximal end 1654 of the inner shaft 1636) provides a visual indication of a measure of tension in the contraction member 226. The tubular shaft may also protrude beyond the proximal end 1639 of the outer housing 1632, at least after the tubular shaft 1634 has begun to advance proximally. For these applications, the inner shaft 1636 may be marked with a plurality of reference marks 1626 arranged along the inner shaft 1636 to indicate the relative axial position of the tubular shaft 1634 relative to the inner shaft 1636. For example, when the proximal end 1652 of the tubular shaft 1634 and the proximal end 1654 of the inner shaft 1636 are set to an initial offset distance D1 between them, the reference mark 1626 can provide a reading of zero or near zero, as shown in Figures 22A to 22B (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).

It should be noted that the force gauge 1624 does not measure the length of the contraction member 226 housed in the handle portion 1620 (this housed length is equal to the distance the inner shaft 1636 moves proximally). As mentioned above, the initial portion of the housed length is sometimes caused by the proximal movement of the inner shaft 1636, while the tubular shaft 1634 moves proximally, roughly one in front of the inner shaft 1636, before the contraction member 226 is tensioned. During this optional initial movement, the tension in the contraction member 226 does not increase significantly, even though the handle portion 1620 houses the contraction member 226.

More generally, the inner shaft 1636 can be considered as the axially movable portion of the force gauge 1624. The axially movable portion of the force gauge 1624 is axially movable relative to the outer housing 1632 (and generally 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).

For some applications, the inner shaft 1636 does not protrude beyond the proximal end 1639 of the outer housing 1632. In such cases, the handle portion 1620 does not provide a non-electromechanical force gauge 1624. However, the handle portion 1620 remains perfectly useful for adjusting the tension in the contraction member 226, such as in configurations where the handle portion 1620 also includes a tension limiting locking assembly 1658 for limiting the maximum tension that the inner shaft 1636 can apply to the contraction member 226, as described below.

Referring again to Figures 24A-24B and 25A-25B. Also referring to Figures 26A-26B, which are schematic diagrams of a portion of an outer housing 1632 and a tubular shaft 1634 according to some applications. For clarity, the inner shaft 1636 is not shown. For some applications, the handle portion 1620 also includes a tension limiting locking assembly 1658 configured to axially lock the inner shaft 1636 relative to the outer housing 1632 when the handle portion 1620 increases the tension in the contraction member 226 to a predetermined threshold level, thereby limiting the maximum tension that the inner shaft 1636 can apply to the contraction member 226. The tension limiting locking assembly 1658 may be configured to axially lock the inner shaft 1636 relative to the outer housing 1632 when the tubular shaft 1634 is positioned relative to the inner shaft 1636 at a predetermined relative axial position, thereby limiting the maximum tension that the inner shaft 1636 can apply to the contraction member 226. The tension limiting locking assembly 1658 can also be configured to axially lock the tubular shaft 1634 relative to the outer housing 1632 when the tubular shaft 1634 is positioned relative to the inner shaft 1636 at a predetermined relative axial position.

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

As shown in the transitions between Figures 24A and 24B and Figures 25A and 25B, as the spring 1646 is further compressed, the distal force applicator 1642 moves axially closer to the inner shaft 1636, causing the tubular shaft 1634 to move proximally relative to the inner shaft 1636. 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 a maximum tension offset distance D3 (which, as shown, may optionally be zero or close to zero), which is less than the tension offset distance D2 and equal to the aforementioned predetermined relative axial position of the tubular shaft 1634 relative to the inner shaft 1636. Typically, but not necessarily, a relatively small portion of the inner shaft 1636 still protrudes from the proximal end 1652 of the tubular shaft 1634, particularly in configurations where the shank portion 1620 provides a non-electromechanical force gauge 1624, as described above.

In applications where the implant includes an implantable annulus remodeling structure 222, the implantable annulus remodeling structure includes a flexible cannula 26, the cannula 26 of which is connected to the annulus 240 and can be in a tensioned or contracted state.

The tension limiting locking assembly 1658 optionally eliminates the need for the non-electromechanical force gauge 1624 described above. Furthermore, for 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 focus their attention on other aspects of the procedure, such as fluorescent imaging. Typically, the predetermined relative axial position of the tubular shaft 1634 relative to the inner shaft 1636 has the effect of setting a predetermined maximum tension, which can be applied to the contraction member 226 using the contraction member receiving tool 1600.

It should be noted that the tension limiting locking assembly 1658 does not typically lock the inner shaft 1636 axially in direct response to the length of the retractable member 226 housed in the handle portion 1620 (the housed length is equal to the distance the inner shaft 1636 moves proximally). Furthermore, the tension limiting locking assembly 1658 does not typically lock the inner shaft 1636 axially in direct response to relative axial movement between the inner shaft 1636 and the outer housing 1632, or directly in response to relative axial movement between the tubular shaft 1634 and the outer housing 1632. As described above, the initial portion of the housed length is sometimes caused by proximal movement of the inner shaft 1636, while the tubular shaft 1634 moves proximally, approximately one in front of the inner shaft 1636, before the retractable member 226 is tensioned. Since the tension limiting locking assembly 1658 is typically configured to axially lock the inner shaft 1636 relative to the outer housing 1632 when the tubular shaft 1634 is positioned relative to the inner shaft 1636 at a predetermined relative axial position, the tension limiting locking assembly 1658 is not affected or triggered by any forward or backward movement of the inner shaft 1636 and the tubular shaft 1634 relative to each other.

For some applications, the pawl 1660 is axially fixedly connected to the inner shaft 1636 and is configured to move radially outward to engage the outer housing 1632, thereby axially locking the inner shaft 1636 relative to the outer housing 1632, as shown in Figures 24A and 24B. For example, a pawl spring 1684 may be provided, which applies a radially outward guiding force to the pawl 1660. The shank portion 1620 is configured such that, when the tubular shaft 1634 is not positioned relative to the inner shaft 1636 in a predetermined relative axial position, as shown in Figures 22A and 23B, elements of the shank portion 1620 prevent radially outward movement of the pawl 1660, for example, as described below. As used herein, "radially outward" means in a direction away from the central longitudinal axis of the outer housing 1632, and "radially inward" means in the opposite direction towards the central longitudinal axis.

For some applications, the tension-limiting locking assembly 1658 also includes an outer housing 1632 shaped to define a plurality of recesses 1662. A pawl 1660 engages with the recesses 1662 to axially lock the inner shaft 1636 relative to the outer housing 1632. The shank portion 1620 is arranged such that when the tubular shaft 1634 is positioned relative to the inner shaft 1636 in a predetermined relative axial position, a particular recess in the recesses 1662 that engages with the pawl 1660 depends on the relative axial position of the inner shaft 1636 relative to the outer housing 1632. In this arrangement, even though the relative axial position of the tubular shaft 1634 relative to the inner shaft 1636 is predetermined, at which the pawl 1660 axially locks the inner shaft 1636 relative to the outer housing 1632, the relative positions of the tubular shaft 1634 and the inner shaft 1636 relative to the outer housing 1632 can be changed to accommodate different initial degrees of slack in the contraction member 226.

In some applications, the proximal longitudinal portion 1637 of the tubular shaft 1634 is shaped to define an elongated opening 1664 through which the pawl 1660 passes when the inner shaft 1636 is axially locked relative to the outer housing 1632. In some of these applications, the tubular shaft 1634 includes one or more tracks 1666 that extend side-by-side with the longitudinal portion of the elongated opening 1664 and are arranged as follows:

• When the tubular shaft 1634 is positioned distally relative to the inner shaft 1636 to a predetermined relative axial position, the pawl 1660 is prevented from axially locking the inner shaft 1636 relative to the outer housing 1632 (by preventing radial outward movement of the pawl 1660), and

• When the tubular shaft 1634 is positioned relative to the inner shaft 1636 in a predetermined relative axial position, the pawl 1660 is allowed to axially lock the inner shaft 1636 (by allowing the pawl 1660 to move radially outward).

One or more rails 1666 may have a portion of the inner shaft 1636 that prevents the pawl 1660 from axially locking relative to the outer housing 1632, which may be radially positioned inside the portion of the inner shaft 1636 that allows the pawl 1660 to axially lock the inner shaft 1636.

For some of these applications, the proximal longitudinal portion 1637 of the tubular shaft 1634 includes one or more pawl supports 1688, which are fixed to a pawl 1660 and configured to slide axially along one or more tracks 1666. When the tubular shaft 1634 is positioned distal to a predetermined relative axial position, the one or more tracks 1666 prevent radial outward movement of the one or more pawl supports 1688, thereby preventing radial outward movement of the pawl 1660. For some applications, the proximal longitudinal portion 1637 of the tubular shaft 1634 includes one or more pawl support posts 1690, which stabilize the one or more pawl supports 1688 during their radial movement; the one or more pawl supports 1688 can slide radially relative to the one or more pawl support posts 1690.

For some of these applications, one or more tracks 1666 are shaped to define one or more corresponding ramp portions 1668. After the pawl 1660 axially locks the inner shaft 1636 relative to the outer housing 1632 when the tubular shaft 1634 is positioned relative to the inner shaft 1636 in a predetermined relative axial position, subsequent distal guide movement of the tubular shaft 1634 and corresponding distal guide movement of one or more tracks 1666 relative to the inner shaft 1636 disengages the pawl 1660 from the outer housing 1632. For example, this disengagement can be caused by one or more ramp portions 1668 sliding one or more pawl supports 1688 radially inward onto radially inwardly positioned portions of one or more tracks 1665. The distal guide movement of the tubular shaft 1634 can be caused by actuating a contraction-promoting knob 1630 in a direction opposite to the actuation direction of the proximal guide movement described above. This allows the user to reduce the tension in the contraction member 226 during the procedure (if needed), even if the tension level is high enough to trigger the tension-limiting lock of the pawl 1660. Of course, if needed, the user can also reduce the tension in the contraction member 226 even before the tension-limiting lock of the pawl 1660.

For some applications, once the desired tension level in the contractile member 226 is achieved (by monitoring the force gauge 1624, by the pawl 1660 which limits the maximum tension, and/or, for example, by monitoring the degree of valve regurgitation under echocardiographic and/or fluoroscopic guidance), the contractile member receiving tool 1600 locks the contractile member 226 to maintain the tension level in the contractile member 226, thereby keeping the contractile member 226 (and optionally structure 222, if provided) in a contracted state.

For some applications, as best seen in the enlarged view in Figure 25B, the pawl 1660 and/or the notch 1662 are slightly angled relative to a direction perpendicular to the central longitudinal axis of the handle portion 1620 (e.g., between 1 degree and 45 degrees, such as between 1 degree and 30 degrees, such as between 1 degree and 15 degrees, such as about 5 degrees), such that the pawl 1660 faces slightly proximally and/or the opening of the notch 1662 faces slightly distally. This angle makes it easy for the pawl to lock and engage with the notch 1662, and also easy to disengage, if necessary, as described above. Alternatively, the pawl 1660 and/or the notch 1662 are not angled and are perpendicular to the central longitudinal axis of the handle portion 1620.

Referring again to Figures 21A and 21B. For 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 between them at an initial offset distance D1. Typically, the shank portion 1620 is configured to maintain this preload before use by preventing the inner shaft 1636 from advancing proximally relative to the tubular shaft 1634 beyond a predetermined maximum distance. For example, the proximal end of the elongated opening 1664 (e.g., as shown in Figure 22B) can prevent proximal advancement of elements of the tension limiting locking assembly 1658 (e.g., one or more pawl support posts in the pawl support posts 1690 or the proximal portions of one or more pawl supports 1688, as labeled in Figure 26A). The preload setting will be described immediately below.

Referring again to Figure 21B. For some applications, the radially inward surface of the tubular shaft 1634 near its distal end is formed to define a thread 1682, and the radially outward surface of the distal force applicator 1642 is formed to define a corresponding thread 1686. During the calibration procedure in the manufacturing process of the shank portion 1620, the threads allow for adjustment of the precise axial position of the distal force applicator 1642 relative to the tubular shaft 1634 by rotating it 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. During the use of the shank portion 1620 in medical procedures, as described above, the distal force applicator 1642 is rotationally fixed and therefore axially fixed relative to the tubular shaft 1634.

For some applications, during calibration procedures, the axial position adjustment spring 1646 of the distal force applicator 1642 relative to the tubular shaft 1634 is preloaded (by compressing the spring) to set the desired level of maximum tension that the inner shaft 1636 can apply to the contraction member 226. For example, a distally guided force can be applied to the proximal end 1654 of the inner shaft 1636 until the offset distance between the proximal end 1652 of the tubular shaft 1634 and the proximal end 1654 of the inner shaft 1636 is reduced to the maximum tension offset distance D3 (at which the tension limiting locking assembly 1658 is triggered during subsequent use). This applied distally guided 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 distally guided force is equal to the desired level of maximum tension that the inner shaft 1636 can apply to the contraction member 226 before triggering the tension limiting locking assembly 1658 during subsequent use. When the calibrated distal guiding force is removed, spring 1646 will extend until further advance of inner shaft 1636 is stopped, as described above, and spring 1646 will have the desired level of preload.

Referring again to Figures 1 through 26B. Systems 10, 510, 700, 800, 900, 1000, 1100, 1200, 1300, 1350, 1400, 1480, and 1500, along with the methods for repairing dilated valve annulus in patients, can be used to treat any heart valve in a patient, such as the aortic valve, pulmonary valve, mitral valve, and tricuspid valve. Furthermore, the valve treatment systems described herein can be used to treat other annular muscles in a patient's body. For example, the systems described herein can be used to treat the sphincter muscles in a patient's stomach.

Referring again to Figures 1 through 26B. Systems 10, 510, 700, 800, 900, 1000, 1100, 1200, 1300, 1350, 1400, 1480, and 1500 can be anchored to the tissue of the valvular ring using any anchoring device (including anchor actuators and deployment manipulators) described in U.S. Patent Application Publication 2015/0272734 granted to Sheps et al.

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

Referring now to Figures 1 through 26B. The tools described herein can be used to deploy, anchor, and adjust the periphery of any annulus forming structure, such as a complete (or closed) annulus forming structure or a partial (or open) annulus forming structure. Any tool described herein can be coupled to the annulus forming structure using any of the couplings described herein with reference to Figures 7A through 26B. For example, any annulus forming structure described herein may include a housing 930 having a female coupling 927, and the tools described herein may include a male coupling 925 tool as described above with reference to Figures 12, 13, and 15. The annulus forming structures described herein may include elements and structures as described in PCT Publication WO 10/073246 granted to Cabiri et al., which is incorporated herein by reference.

Additionally, the applications described in one or more of the following documents can be used in conjunction with various embodiments of this disclosure:

• U.S. Patent Application No. 12/435,291, filed on May 4, 2009, entitled “Adjustable repair chords and spool mechanism therefor”, was granted to Maisano et al., which is U.S. Patent No. 8,147,542.

• U.S. Patent Application 12/437,103, entitled “Annuloplasty ring with intra-ring anchoring”, filed on May 7, 2009, and granted to Zipory et al., is U.S. Patent 8,715,342.

• U.S. Patent Application 12/548,991, entitled “Implantation of repair chords in the heart”, filed on August 27, 2009, and granted to Maisano et al., is U.S. Patent 8,808,368.

• PCT patent application PCT/IL2009/001209 entitled “Adjustable annuloplasty devices and mechanisms therefor”, filed on December 22, 2009, and granted to Cabiri et al., was published as PCT WO 10/073246.

• PCT patent application PCT/IL2010/000357 entitled “Implantation of repair chords in the heart”, filed on May 4, 2010, and granted to Maisano et al., was issued as WO 10/128502;

• PCT patent application PCT/IL2010/000358, entitled “Deployment techniques for annuloplasty ring and over-wire rotation tool”, filed on May 4, 2010, and granted to Zipory et al., was issued as WO 10/128503;

• U.S. patent application published 2014/0309661 to Sheps et al.; and/or

• U.S. patent application granted to Sheps et al., published 2015/0272734.

All of these applications are incorporated herein by reference. The techniques described herein may be practiced in conjunction 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 performed on a living animal or in a simulation/simulation method (e.g., on a cadaver, a cadaver's heart, a simulator with simulated hearts, tissues, etc., an anthropomorphic mannequin, etc.).

This invention is not limited to the contents specifically shown and described above. Rather, the scope of this invention includes both combinations and sub-combinations of the various features described above, as well as variations and modifications of combinations and sub-combinations that are outside the scope of the prior art, which should be apparent to those skilled in the art upon reading the above description.

Claims (32)

1. An apparatus comprising: Implantable annulus remodeling structure, the implantable annulus remodeling structure comprising: Main parts; and A shrinking member having (1) a first portion extending along the longitudinal length of the main portion of the annular forming structure, and (2) a second portion extending away from the main portion of the annular forming structure; and Shrinkable component receiving tool, the shrinkable component receiving tool comprising: The main tube terminates at the distal end portion of the retractable member receiving tool, the distal end portion of the retractable member receiving tool having a distal tip; A secondary pipe, arranged side-by-side with the main pipe, the secondary pipe having a secondary pipe lumen configured for the constriction member to pass through; and A contraction member snare, the contraction member snare including a distal snare portion and an elongated flexible portion connected to the distal snare portion, the distal snare portion being configured to snare a portion of the contraction member and being sized to pass through the lumen of the secondary tube to pull the second portion of the contraction member through the secondary tube by a length. The snare portion includes a flexible ring, and the size of the secondary tube lumen is set to maintain the connection between the distal snare portion and the contraction member by causing the ring to collapse around the contraction member when the elongated flexible portion is pulled through the secondary tube lumen. 2. The device of claim 1, wherein the distal snare portion is configured to pull the second portion of the retractable member through the distal tip of the retractable member receiving tool and subsequently through the length of the secondary tube. 3. The device according to any one of claims 1 to 2, wherein the shrinking member looper comprises a wire having a diameter of 0.2 mm to 0.25 mm. 4. The device according to any one of claims 1 to 2, wherein the main tube is flexible, and wherein the secondary tube is flexible. 5. The device according to any one of claims 1 to 2, wherein the valve annulus forming structure defines a partial valve annulus forming ring structure. 6. The device according to any one of claims 1 to 2, wherein the secondary tube is shaped to define a longitudinal slit. 7. The device according to any one of claims 1 to 2, wherein the retractable member receiving tool includes a handle portion, and wherein the first tube and the second tube are connected to the handle portion. 8. The device of claim 7, wherein the handle portion comprises: A shrinkable member receiving device, the shrinkable member receiving device being configured to receive a continuous portion of the shrinkable member; and A tension meter, configured to measure the degree of tension of the contraction member. 9. The device of claim 8, wherein the shrinkage member receiving device is actuable to increase the tension of the shrinkage member. 10. The device of claim 8, wherein the shrinkage member receiving device includes a knob coupled to a proximal portion of the shrinkage member, the knob being configured to increase the tension of the shrinkage member by pulling the shrinkage member proximal to the side. 11. The device of claim 10, wherein the shrinkage member receiving device includes a wheel having a groove configured to engage the shrinkage member to the wheel. 12. The device of claim 11, wherein the groove is shaped to receive the middle portion of the contraction member. 13. The device according to any one of claims 1 to 2 and 8 to 12, 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. 14. The device according to any one of claims 1 to 2 and 8 to 12, wherein the distal snare portion is configured to pull the second portion of the contraction member through the entire length of the sub-tube. 15. The device according to any one of claims 1 to 2 and 8 to 12, wherein the retractable member receiving tool comprises: At least one retractable member fastener disposed within the distal end portion of the retractable member receiving tool, the retractable member fastener including a clamping structure, the clamping structure being (a) biased toward a closed state, in which the clamping structure is configured to clamp onto the retractable member passing through it, and (b) flexible to an open state through which the retractable member can move; and A stop member is removably coupled to the retractable member fastener and configured to hold the retractable member fastener in the open state. 16. The device of claim 15, wherein the at least one shrink member fastener comprises at least a first shrink member fastener and a second shrink member fastener, the first shrink member fastener and the second shrink member fastener being disposed within the distal end portion of the shrink member receiving tool. 17. The device of claim 16, wherein the distal snare portion of the retractable member snare and the elongated flexible body portion are sized to pass distally through the retractable member fastener in the open state, the snare portion being adapted to capture the retractable member and pull the retractable member proximally through the retractable member fastener and through an alignment port in the distal end portion of the retractable member receiving tool. 18. The device of claim 17, wherein the retractable member receiving tool includes a fastener-ejector movable within the distal end portion of the retractable member receiving tool, and wherein the movement of the fastener-ejector contacts the retractable member fastener and transitions the retractable member fastener from the open state to the closed state to clamp onto the retractable member passing through it. 19. The device of claim 18, wherein the fastener-ejector is coupled to the stop and the stop is movably removably coupled to the fastener. 20. The device according to any one of claims 18 to 19, wherein the distal end portion of the retractable member receiving tool is shaped to define a sharp edge, and wherein the retractable member is configured adjacent to the sharp edge such that a movement of the fastener-ejector against the sharp edge cuts through the retractable member extending through the fastener. 21. The apparatus according to any one of claims 1 to 2, 8 to 12, and 16 to 19, further comprising: At least one retractable member fastener, the at least one retractable member fastener being configured to surround the retractable member, the retractable member fastener including a clamping structure, the clamping structure being (a) biased toward a closed state, in which the clamping structure is configured to clamp onto the retractable member passing through it, and (b) flexible to an open state through which the retractable member can move; and A stop member is removably coupled to the retractable member fastener and configured to hold the retractable member fastener in the open state. 22. The device of claim 21, wherein the tool comprises a movable cutting element having a sharp edge, and the movement of the stop abuts against the movable cutting element and hammers the stop such that the movement of the movable cutting element cuts through the fastener and through the contraction member of the movable cutting element. 23. The device according to any one of claims 1 to 2, 8 to 12, 16 to 19, and 22, further comprising: a lock slidable along the retractable member, the lock being fixedly coupled to the retractable member to prevent movement of the retractable member, wherein: The lock is shaped to define a slit extending from the proximal surface of the lock toward the distal surface of the lock. The lock defines a lock cavity that extends from a proximal opening in the lock toward a distal opening in the lock. The locking cavity is configured to surround the contractile member, and When the lock is compressed, the slit allows the lock to close around the contraction member, thereby locking the lock to the contraction member. 24. The device of claim 23, wherein the valve ring forming structure is shaped to define a recess, the size of which is set to compress the lock when the lock is at least partially disposed within the recess. 25. The device of claim 24, wherein the size of the recess is set to compress the lock when the lock is at least partially disposed within the recess. 26. The device of claim 23, wherein the locking cavity is shaped to define a distal portion that is wider than the proximal portion of the locking cavity. 27. The device of claim 26, wherein the recess is shaped to define a proximal portion that is narrower than any other portion of the recess remote from the proximal portion. 28. The device of claim 23, wherein the lock is disposed within the distal end portion of the retractable member receiving tool. 29. The device of claim 28, wherein when the contraction member receiving tool is coupled to the valve ring forming structure, the lock is at least partially disposed within the recess. 30. The device of claim 28, wherein when the contraction member receiving tool is coupled to the valve ring forming structure, the lock is fully disposed on the proximal side of the recess. 31. The device of claim 23, wherein the lock is disposed within the distal end portion of the retractable member receiving tool. 32. The device of claim 31, wherein the distal snare portion and the elongated flexible body portion of the retractable member snare are sized to pass distally through the lock, the snare portion being adapted to capture the retractable member and pull the retractable member proximally through the lock and through an alignment port in the distal end portion of the retractable member receiving tool.