Annuloplasty system and locking tool thereof

Abstract

The present invention provides a device, the device comprising an implantable annuloplasty structure (1152), the annuloplasty structure comprising a body portion and a contraction member (226). A contraction member fastener (1560) may surround the contraction member and include a clamping structure, the clamping structure being biased toward a closed state to clamp on the contraction member passing therethrough. A stopper (1570) may be removably coupled to the fastener and retain the fastener in an open state. A contraction member receiving tool (1502) may include a static cutting element and a dynamic cutting element (1510, 1520) and a grasper (1505), the grasper being configured to pull the stopper proximally so that the stopper pushes against the dynamic cutting element and moves the dynamic cutting element relative to the static cutting element to facilitate severing the contraction member. Other applications are also provided.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to:

[0003] a) U.S. Provisional Patent Application 62 / 697,186, filed on July 12, 2018, entitled “Annuloplasty system and locking tool therefor,” to Brauon et al.; and

[0004] b) U.S. Provisional Patent Application 62 / 811,693, filed on February 28, 2019, entitled “Annuloplasty system and locking tool therefor,” to Brauon et al.

[0005] Both applications are incorporated herein by reference. Technical Field

[0006] The present invention relates generally to valve repair, for example to the repair of an atrioventricular valve in a patient. Background Art

[0007] Ischemic heart disease can cause valvular regurgitation. For example, mitral regurgitation may be caused by a combination of ischemic dysfunction of the papillary muscles and left ventricular dilatation present in ischemic heart disease with subsequent displacement of the papillary muscles and dilation of the mitral annulus.

[0008] Dilation of the mitral annulus prevents the valve leaflets from fully coapting when the valve closes. Mitral regurgitation of blood from the left ventricle to the left atrium results in an increase in total stroke volume and a decrease in cardiac output, as well as eventual weakening of the left ventricle secondary to left atrial volume and pressure overload. Summary of the invention

[0009] The present disclosure is intended to provide some examples and is not intended to limit the scope of the present invention in any way. For example, any features included in the examples of the present disclosure are not required by the claims unless the claims explicitly recite these features. In addition, the features, components, steps, concepts, etc. described in the examples of the present disclosure and elsewhere in this disclosure can be combined in a variety of ways. The description herein relates to systems, components, methods, devices, equipment, 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 here.

[0010] In some applications, a multi-component tubular system for approaching a patient's heart is provided. The system may include one or more (e.g., 1, 2, 3 or more) steerable guide catheters, which are configured to guide a device to enter the heart through them. The multi-component tubular system may be configured to deliver an implant to the annulus of a patient's heart valve in a desired orientation and facilitate anchoring the implant to the annulus. For some applications, the guide system may be advanced transcavitary or transthoracic, or may be able to be advanced transcavitary or transthoracic, thereby approaching the atrium of the heart. For some applications, the guide system may be surgically advanced. The system may include two or more steerable catheters. The first catheter has a distal portion that is steerable to a first desired spatial orientation. The second catheter is disposed in the first catheter and has a distal portion that is steerable to a second desired spatial orientation. The system provides a technique and a relative spatial orientation control device for controlling the orientation of the distal portion of the second catheter relative to the first catheter without substantially deforming the first spatial orientation of the distal portion of the first catheter. For some applications, the relative spatial orientation control device includes a rotation locking mechanism provided by a component of the catheter system.

[0011] 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. After the advancement of the first catheter and the manipulation of the distal portion of the first catheter in any one or more suitable planes, the second catheter is advanced through the first catheter. The first catheter and the second catheter can be rotationally locked so that the distal portion of the second catheter can be manipulated in any one or more suitable planes relative to the distal portion of the first catheter in the mode of the spatial orientation of the first catheter that is kept substantially during the manipulation of the second catheter. In addition, the first catheter can be further manipulated without substantially destroying the spatial orientation of the distal portion of the second catheter.

[0012] The distal portions and / or distal ends of the first and second catheters can be configured so that once they have been positioned within the atrium of the patient's heart, an implantable, adjustable annuloplasty structure (e.g., annuloplasty ring structure, a closed annuloplasty structure, a closed annuloplasty ring structure, an open annuloplasty structure, a partial annuloplasty ring structure, or other annuloplasty device) can be deployed, for example, from within the second catheter and anchored to the annulus of the patient's heart valve. The annuloplasty structure can include a flexible main body portion and a contraction member having a first portion extending along the longitudinal length of the main body portion. The second portion of the contraction member can extend away from the main body portion of the annuloplasty structure and extend outside the patient's body. From a position outside the patient's body, a contraction member snare of a contraction member receiving tool is used to snare the proximal end portion of the contraction member disposed outside the patient's body. Using the snare, the proximal end portion of the contraction member can then be fed through the distal portion of the main tube of the tool and subsequently through the lumen of the secondary tube of the tool. The contraction member receiving tool can then be advanced along the contraction member toward the annulus of the patient. During advancement of the tool toward the annulus, when the contraction member passes through the lumen of the secondary tube of the tool by being pulled by the snare, the secondary tube of the tool may move distally along the contraction member.

[0013] The retraction member receiving tool may include an ejector that can be moved on the distal end portion of the tool. The ejector can be removably connected to a suture fastener, which includes a clamping structure that can be deflected 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 on the retraction member passing therethrough. The tool may have at least one stop that holds the suture fastener (e.g., its clamping structure) in its open state.

[0014] The snare portion can be configured or adapted to capture the contraction 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 annuloplasty structure implanted along the annulus. The tool can then receive a continuous portion of the contraction member to contract the annuloplasty structure. Subsequently, the ejector of the tool can be moved and the suture fastener (e.g., its clamping structure) can be converted from its open state to its closed state to clamp on the contraction member passing therethrough.

[0015] The tool may include a handle portion, which may include a contraction member receiving device that receives a continuous portion of the contraction member. The handle portion may include a tensiometer configured to measure the degree of tension of the contraction member.

[0016] For some applications, an annuloplasty structure (e.g., an annuloplasty ring structure, a closed annuloplasty structure, a closed annuloplasty ring structure, an open annuloplasty structure, a partial annuloplasty ring structure, or other annuloplasty device) includes a body portion including a collapsible sleeve, a contraction member threaded along the collapsible sleeve, and a housing including a fastener through which the contraction member passes. Once the annuloplasty structure or annuloplasty ring structure has been contracted, the fastener is deployed within the housing to maintain the contraction of the annuloplasty structure or annuloplasty ring structure.

[0017] A contraction member cutting tool is provided, wherein it is possible to cut a contraction member passing through the tool only when the contraction member has been locked in place by a fastener connected thereto. The contraction member cutting tool can be configured in a variety of ways to apply a cutting surface to the contraction member, for example, with a sharp edge that moves toward the contraction member; multiple edges and / or surfaces that move relative to each other, such as in a scissor-like motion or similar to a wire cutting tool; and the like.

[0018] Thus, according to some applications, a system and / or apparatus is provided that includes an implantable annuloplasty structure. The annuloplasty structure includes a main body portion and a contraction member. In some embodiments, the contraction member can have (1) a first portion extending along a longitudinal length of the main body portion of the annuloplasty structure, and (2) a second portion extending away from the main body portion of the annuloplasty structure.

[0019] The system and / or device may include a contraction member receiving tool. The contraction member receiving tool may include a main tube terminating at a distal end portion of the contraction member receiving tool, the distal end portion of the contraction member receiving tool having a distal tip, and a secondary tube arranged side by side with the main tube, the secondary tube having a secondary tube lumen, the secondary tube lumen being configured to allow the contraction member to pass therethrough. In some embodiments, the contraction member receiving tool also includes a contraction member snare, the contraction member snare including a distal snare portion and an elongated flexible body portion coupled to the distal snare portion, the distal snare portion being configured to trap a portion of the contraction member. The size of the contraction member snare can be set to pass through the secondary tube lumen of the secondary tube so as to pull the second portion of the contraction member through the length of the secondary tube.

[0020] For some applications, the distal snare portion is configured to pull the second portion of the retraction member through the distal tip of the retraction member receiving tool and subsequently through the length of the secondary tube.

[0021] For some applications, the retraction member snare comprises a wire comprising stainless steel.For some applications, the retraction member snare comprises a wire having a diameter of 0.2 mm to 0.25 mm.

[0022] For some applications, the primary and / or secondary pipes are flexible.

[0023] For some applications, the annuloplasty structure defines a complete annuloplasty ring structure.For some applications, the annuloplasty structure defines a partial annuloplasty ring structure.

[0024] For some applications, the secondary tube is shaped to define a longitudinal slit.

[0025] For some applications, the retraction member receiving tool includes a handle portion, and the first tube and the second tube are connected to the handle portion.

[0026] For some applications, the handle portion includes a retraction member receiving device configured to receive a continuous portion of the retraction member and a tension meter configured to measure a degree of tension in the retraction member.

[0027] For some applications, the retraction member receiving device is actuatable to increase the tension of the retraction member.

[0028] For some applications, the retraction member receiving device includes a knob coupled to a proximal portion of the retraction member, the knob being configured to increase tension of the retraction member by pulling the retraction member proximally. For some applications, the knob is fixedly coupled to the proximal portion of the retraction member.

[0029] For some applications, the retraction member receiving device includes a wheel having a groove configured to couple the retraction member to the wheel.For some applications, the groove is shaped to receive a middle portion of the retraction member.

[0030] For some applications, the secondary tube lumen of the secondary tube is sized to maintain a coupling between the distal snare portion and the retraction member.

[0031] For some applications, the snare portion includes a flexible ring, and the secondary tube lumen is configured to collapse the ring around the constriction member when the elongated flexible body portion is pulled through the secondary tube lumen. For some applications, the secondary tube lumen of the secondary tube has a diameter of 0.5 mm-1.5 mm.

[0032] For some applications, the retraction member snare includes a metal wire.

[0033] For some applications, at least a distal snare portion of the retraction member snare is corrugated to increase friction between the snare portion and the retraction member.

[0034] For some applications, the distal snare portion is configured to pull the second portion of the retraction member through the entire length of the secondary tube.

[0035] For some applications, the retraction member receiving tool includes:

[0036] At least one retraction member fastener, the at least one retraction member fastener being disposed within a distal end portion of a retraction member receiving tool, the retraction member fastener comprising: a clamping structure that (a) is biased toward presenting a closed state, in which the clamping structure is configured to clamp onto a retraction member passing therethrough, and (b) is deflectable to an open state through which the retraction member can move; and a stopper that is removably connected to the retraction member fastener and is configured to maintain the retraction member fastener in an open state.

[0037] For some applications, the at least one retraction member fastener includes at least a first retraction member fastener and a second retraction member fastener disposed within a distal end portion of the retraction member receiving tool.

[0038] For some applications, the distal snare portion and the elongated flexible body portion of the retraction member snare are sized to pass distally through the retraction member fastener in an open state, and the snare portion is adapted to capture the retraction member and pull the retraction member proximally through the retraction member fastener and through an alignment port in a distal end portion of the retraction member receiving tool.

[0039] For some applications, the retraction member receiving tool includes a fastener-ejector movable within a distal end portion of the retraction member receiving tool, and movement of the fastener-ejector contacts the retraction member fastener and transitions the retraction member fastener from an open state to a closed state to clamp onto the retraction member passing therethrough.

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

[0041] For some applications, a distal end portion of the retraction member receiving tool is shaped to define a sharp edge, and the retraction member is disposed adjacent the sharp edge such that movement of the fastener-ejector against the sharp edge severs the retraction member extending through the fastener.

[0042] For some applications, the system and / or apparatus further includes:

[0043] At least one retraction member fastener, the at least one retraction member fastener being configured to surround a retraction member, the retraction member fastener comprising: a clamping structure that is (a) biased toward presenting a closed state, in which the clamping structure is configured to clamp on the retraction member passing therethrough, and (b) can be flexed to an open state through which the retraction member can move; and a stopper that is removably connected to the retraction member fastener and is configured to maintain the retraction member fastener in the open state.

[0044] For some applications, the retraction member receiving tool includes a fastener-ejector movable within a distal end portion of the retraction member receiving tool, and movement of the fastener-ejector is configured to transition the retraction member fastener from an open state to a closed state to clamp onto the retraction member passing therethrough.

[0045] For some applications, the fastener-ejector is removably coupled to a stopper and moves a stopper that is removably coupled to the fastener.

[0046] For some applications, the tool includes a movable cutting element having a sharp edge, and movement of the stop hammers the stop against the movable cutting element such that movement of the movable cutting element severs the retraction member extending through the fastener and through the movable cutting element.

[0047] For some applications, the system and / or device also includes a lock that can slide along the contraction member, and the lock can be fixedly coupled to the contraction member to prevent movement of the contraction member. The lock can be shaped to define a slit extending from a proximal surface of the lock toward a distal surface of the lock. The lock can define a lock cavity of the lock, which extends 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. In some applications, when the lock is compressed, the slit enables the lock to close around the contraction member and thereby lock the lock to the contraction member.

[0048] For some applications, the annuloplasty structure is shaped to define a recess that is sized to compress the lock when the lock is at least partially disposed within the recess.

[0049] For some applications, the recess is sized to compress the lock when the lock is at least partially disposed within the recess.

[0050] For some applications, the locking cavity is shaped to define a distal portion that is wider than a proximal portion of the locking cavity.

[0051] For some applications, the recess is shaped to define a proximal portion that is narrower than any other portion of the recess distal to the proximal portion.

[0052] For some applications, the lock is disposed within a distal end portion of the retraction member receiving tool.

[0053] For some applications, the lock is at least partially disposed within the recess when the retraction member receiving tool is coupled to the annuloplasty structure.

[0054] For some applications, the lock is disposed completely proximal to the recess when the retraction member receiving tool is coupled to the annuloplasty structure.

[0055] For some applications, the lock is disposed within a distal end portion of the retraction member receiving tool.

[0056] For some applications, the distal snare portion and the elongated flexible body portion of the retraction member snare are sized to pass distally through the lock, the snare portion being adapted to capture the retraction member and pull the retraction member proximally through the lock and through an alignment port in a distal end portion of the retraction member receiving tool.

[0057] According to some applications, a system and / or device is further provided that includes an implantable annuloplasty structure. The implantable annuloplasty structure includes a body portion and a contraction member. The contraction member may have (1) a first portion extending along a longitudinal length of the body portion of the annuloplasty ring structure, and (2) a second portion extending away from the body portion of the annuloplasty ring structure.

[0058] The systems and / or devices may also include a housing configured to be positionable against a body portion of the annuloplasty ring structure.

[0059] The system and / or device may also include a retraction member fastener at least partially disposed within the housing, the retraction member fastener comprising a clamping structure that (a) is biased toward presenting a closed state in which the clamping structure is configured to clamp onto a retraction member passing therethrough, and (b) can be deflected to an open state through which the retraction member can move.

[0060] The system and / or apparatus may further include a stop removably coupled to the fastener and configured to hold the retraction member fastener in an open state and a fastener-pop-up engageable with the stop such that movement of the fastener-pop-up moves the stop removably coupled to the fastener and transitions the clamping structure from an open state to a closed state to clamp on the retraction member passing therethrough.

[0061] For some applications, the fastener-ejector is shaped so that its movement facilitates severing of a retraction member extending through the fastener.

[0062] For some applications, the fastener includes a deformable element having an inclined state and a straight state, the stopper is configured to maintain the fastener in the inclined state, and when the stopper is removed, the fastener is configured to transition to the straight state and cause the retraction member to be located between the fastener and a surface of the housing.

[0063] For some applications, the fastener is shaped to define a plurality of teeth configured to increase friction between the retraction member and the fastener.

[0064] According to some applications, a method is also provided that includes advancing an implantable annuloplasty structure toward a patient's heart, the implantable annuloplasty structure including a main body portion and a contraction member. The contraction member is the same or similar to other contraction members described herein and may have (1) a first portion extending along a longitudinal length of the main body portion of the annuloplasty structure, and (2) a second portion extending away from the main portion of the annuloplasty ring structure.

[0065] The method also includes threading the second portion of the contraction member through a contraction member receiving tool. The contraction member receiving tool may include a main tube terminating at a distal end portion of the contraction member receiving tool, the distal end portion of the contraction member receiving tool having a distal tip, and a secondary tube arranged side by side with the main tube, the secondary tube having a secondary tube lumen, the secondary tube lumen being configured to allow the contraction member to pass therethrough. The contraction member receiving tool may also include a contraction member snare, the contraction member snare including a distal snare portion and an elongated flexible body portion coupled to the distal snare portion, the distal snare portion being configured to trap a portion of the contraction member and being sized to pass through the secondary tube lumen of the secondary tube so as to pull the second portion of the contraction member through the length of the secondary tube.

[0066] For some applications, threading includes using the distal snare portion to snare the portion of the contraction member; using the contraction member snare to pull the portion of the contraction member through the secondary tube; and after threading, advancing the contraction member receiving tool along the contraction member toward the annuloplasty structure.

[0067] For some applications, threading the second portion of the retraction member includes threading the second portion of the retraction member after advancing.

[0068] For some applications, pulling the portion of the retraction member through the secondary tube includes pulling a second portion of the retraction member through a distal tip of the retraction member receiving tool and subsequently through the length of the secondary tube.

[0069] For some applications, pulling the portion of the retraction member through the secondary tube includes tightening a coupling between the retraction member and the snare portion.

[0070] For some applications, the method further includes, after advancing the contraction member receiving tool, contracting the annuloplasty structure using the contraction member receiving tool.

[0071] For some applications, contracting the annuloplasty structure using the contraction member receiving tool includes advancing a continuous portion of the contraction member relative to the contraction member receiving device.

[0072] For some applications, the method further includes, after contraction, maintaining the annuloplasty structure in the contracted state by clamping a contraction member fastener around a portion of the contraction member.

[0073] For some applications, clamping includes deploying the fastener from within a distal end portion of the retraction member receiving tool.

[0074] For some applications, the method further includes, after maintaining the annuloplasty structure in the contracted state, severing the contraction member using a sharp edge of the contraction member receiving tool.

[0075] For some applications, advancing the constriction member receiving tool includes advancing the constriction member receiving tool through the vasculature of the patient.

[0076] For some applications, a retraction member receiving tool includes a handle portion including a retraction member receiving device configured to receive a continuous portion of a retraction member and a strain gauge configured to measure a degree of tension in the retraction member.

[0077] For some applications, the method further includes increasing tension in the retraction member using a retraction member receiving device.

[0078] For some applications, the retraction member receiving device includes a wheel and has a groove, and the method further includes coupling the retraction member to the wheel.

[0079] For some applications, coupling the retraction member to the wheel includes coupling an intermediate portion of the retraction member to the wheel.

[0080] The method can be performed in a procedure performed on a live animal or in a simulation / simulation procedure (e.g., on a cadaver, a cadaver heart, a simulator with a simulated heart, tissue, etc., an anthropomorphic ghost, etc.).

[0081] According to some applications, a method is also provided that includes advancing an implantable annuloplasty structure toward a patient's heart. The implantable annuloplasty structure can be the same or similar to other annuloplasty structures described herein or otherwise known, and can include, for example, a body portion, a contraction member, and a housing coupled to the body portion of the annuloplasty structure. For some applications, the contraction member has (1) a first portion extending along a longitudinal length of the body portion of the annuloplasty structure, and (2) a second portion extending away from the body portion of the annuloplasty structure.

[0082] For some applications, a retraction member fastener is disposed within the housing, the retraction member fastener comprising a clamping structure that (a) is biased toward assuming a closed state in which the clamping structure is configured to clamp onto a retraction member passing therethrough, and (b) can be deflected to an open state through which the retraction member can move. For some applications, a stopper is removably coupled to the fastener and is configured to retain the retraction member fastener in the open state.

[0083] For some applications, the method further includes transitioning the retracting member fastener from an open state to a closed state by moving a fastener-ejector engageable with a stopper such that movement of the fastener-ejector moves a stopper removably coupled to the fastener so as to clamp onto the retracting member passing therethrough.

[0084] For some applications, the method further includes, after the advancing, contracting the annuloplasty structure using a contraction member, and transitioning the contraction member fastener from an open state to a closed state, including transitioning after the contraction.

[0085] For some applications, collapsing the annuloplasty structure includes collapsing the annuloplasty structure using a collapsing member receiving tool.

[0086] For some applications, contracting the annuloplasty structure using the contraction member receiving tool includes advancing a continuous portion of the contraction member relative to the contraction member receiving device.

[0087] For some applications, the method further includes severing the retraction member using a sharp edge of the retraction member receiving tool after transitioning the retraction member fastener from the open state to the closed state.

[0088] The method can be performed in a procedure performed on a live animal or in a simulation / simulation procedure (e.g., on a cadaver, a cadaver heart, a simulator with a simulated heart, tissue, etc., an anthropomorphic phantom, etc.).

[0089] According to some applications, a system is also provided, which includes an implantable annuloplasty structure, the implantable annuloplasty structure including a main body portion and a contraction member, the contraction member extending at least partially along the longitudinal length of the main body portion of the annuloplasty structure. The system also includes a contraction member receiving tool. The contraction member receiving tool may include a tube having a lumen and a contraction member snare, the lumen being configured to allow the contraction member to pass therethrough. The contraction member snare may include a distal snare portion and an elongated flexible body portion coupled to the distal snare portion, the distal snare portion being configured to snare a portion of the contraction member and pull it into the lumen.

[0090] For some applications, the distal snare portion is configured to pull the portion of the retraction member through the entire length of the lumen.

[0091] For some applications, the retraction member snare includes a wire comprising stainless steel.For some applications, the tube is flexible.

[0092] For some applications, the retraction member receiving tool includes a handle portion, and the tube is connected to the handle portion.

[0093] For some applications, the handle portion includes a retraction member receiving device configured to receive a continuous portion of the retraction member and a tension meter configured to measure a degree of tension in the retraction member.

[0094] For some applications, the retraction member receiving device is actuatable to increase the tension of the retraction member.

[0095] For some applications, the retraction member receiving device includes a wheel having a groove configured to couple the retraction member to the wheel.

[0096] For some applications, the groove is shaped to receive a middle portion of the retraction member.

[0097] For some applications, the lumen of the tube is sized to maintain a coupling between the distal snare portion and the retraction member.

[0098] For some applications, the distal snare portion includes a flexible ring, and the lumen is configured to collapse the ring around the contraction member as the portion of the contraction member is pulled through the lumen.

[0099] For some applications, at least a distal snare portion of the retraction member snare is corrugated to increase friction between the snare portion and the retraction member.

[0100] For some applications, a distal end portion of the retraction member receiving tool is shaped to define a sharp edge, and the retraction member receiving tool is configured to position the retraction member adjacent the sharp edge such that the sharp edge can sever the retraction member.

[0101] For some applications, the retraction member receiving tool includes:

[0102] a retraction member fastener disposed within a distal end portion of a retraction member receiving tool, the retraction member fastener comprising a clamping structure that (a) is biased toward assuming a closed condition in which the clamping structure is configured to clamp onto a retraction member passing therethrough, and (b) is deflectable to an open condition through which the retraction member can move; and

[0103] A stopper is removably coupled to the retracting member fastener and is configured to retain the retracting member fastener in an open state.

[0104] For some applications, the distal snare portion and the portion of the retraction member snare are sized to pass distally through the retraction member fastener in their open state, and the distal snare portion is adapted to capture the portion of the retraction member and pull the portion proximally through the retraction member fastener and through the alignment port in the distal end portion of the retraction member receiving tool.

[0105] For some applications, the retraction member receiving tool includes a fastener-ejector movable within a distal end portion of the retraction member receiving tool, and movement of the fastener-ejector contacts the retraction member fastener and can transition the retraction member fastener from its open state to its closed state to clamp onto the retraction member as the retraction member passes therethrough.

[0106] For some applications, the fastener-ejector is coupled to a stopper and moves a stopper that is removably coupled to the fastener.

[0107] For some applications, the distal end portion of the retraction member receiving tool is shaped to define a sharp edge, and the retraction member receiving tool is configured to position the retraction member adjacent the sharp edge so that movement of the fastener-ejector against the sharp edge severs the retraction member after the retraction member extends through the fastener.

[0108] For some applications, the implantable annuloplasty structure is a closed annuloplasty structure.

[0109] According to some applications, a system and / or apparatus is also provided that includes an implantable annuloplasty structure including a body portion having a sidewall and a contraction member. In some applications, the contraction member has (1) a first portion extending along a longitudinal length of the body portion of the annuloplasty structure, and (2) a second portion extending away from the body portion of the annuloplasty structure, the contraction member being configured to adjust a circumference of the annuloplasty structure.

[0110] The main body portion of the annuloplasty structure may be formed to define a recess having a recess axis, the recess extending from an opening in a first surface of a side wall of the main body portion toward an opposite second surface of the side wall of the main body portion, the side wall of the main body portion extending away from the recess along a longitudinal axis that is at a non-zero angle relative to the recess axis, and the contraction member extending through the recess and extending away from the main body portion of the annuloplasty structure via the recess.

[0111] The system and / or apparatus may include a lock slidable along the retraction member and toward the recess, the lock fixedly coupled to the retraction member to prevent movement of the retraction member, the recess shaped to facilitate fixed coupling of the lock to the retraction member.

[0112] For some applications, the lock may be disposed at least partially within the recess.

[0113] For some applications, the annuloplasty structure comprises a complete annuloplasty ring structure; in other cases, the annuloplasty structure comprises a partial annuloplasty ring structure.

[0114] For some applications, the lock is configured to lock the retraction member when the lock is moved at least partially within the recess.

[0115] For some applications, the lock is configured to fit completely within the recess.

[0116] For some applications, the body portion includes a housing that defines at least a portion of the sidewall, and the housing defines the recess.

[0117] For some applications, the lock is shaped to define a lock threaded portion, and the annuloplasty structure is shaped to define an annuloplasty structure threaded portion that is configured to engage the lock threaded portion.

[0118] For some applications, the recess defines a recess lumen extending along a recess axis.For some applications, the recess axis is disposed at a non-zero angle.

[0119] For some applications, the lock is shaped to define a slit extending from a proximal surface of the lock toward a distal surface of the lock, the lock defining a lock cavity of the lock extending from a proximal opening in the lock toward a distal opening in the lock, the lock cavity being configured to surround the retraction member, and when the lock is disposed within the recess, the slit enables the lock to close around the retraction member and thereby lock the lock to the retraction member.

[0120] For some applications, the recess is sized to compress the lock when the lock is at least partially disposed within the recess.

[0121] For some applications, the slit is shaped to define a distal portion that is wider than a proximal portion of the slit.

[0122] For some applications, the locking cavity is shaped to define a distal portion that is wider than a proximal portion of the locking cavity.

[0123] For some applications, the recess is shaped to define a proximal-most portion that is narrower than any other portion of the recess distal to the proximal-most portion.

[0124] For some applications, the annuloplasty structure includes a housing, and the housing is shaped to define a recess having a recess axis.

[0125] For some applications, the lock is shaped to define a lock threaded portion, and the housing is shaped to define an annuloplasty structure threaded portion configured to engage the lock threaded portion.

[0126] For some applications, the housing is shaped to define a constriction member lumen that is disposed at a non-zero angle relative to the axis of the recess.

[0127] For some applications, the housing is shaped to provide a contraction member lumen wall disposed along the contraction member lumen, and when the lock is disposed within the recess, the distal end of the lock is configured to squeeze a first portion of the contraction member against the contraction member lumen wall to lock the contraction member at least at the first compression point.

[0128] For some applications, the recess is shaped to define a recess distal tapered portion. For some applications, the lock is shaped to define a lock cavity of the lock and a lock distal tapered portion, 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 the retraction member.

[0129] For some applications, when the lock is disposed within the recess, the recess distal tapered portion is configured to compress the lock distal tapered portion, which in turn is configured to squeeze a second portion of the retraction member within the lock cavity at the recess distal tapered portion to lock the retraction member at at least the second compression point.

[0130] For some applications, the system and / or apparatus further includes a delivery tool, the delivery tool and the retraction member being slidable relative to each other, the delivery tool being configured to deliver the annuloplasty structure to a valve annulus of the patient's heart.

[0131] For some applications, the delivery tool includes a knob coupled to a proximal portion of the retraction member, the knob configured to increase tension in the retraction member by pulling the retraction member proximally.

[0132] For some applications, the knob is fixedly coupled to the proximal portion of the retraction member.

[0133] For some applications, when the delivery tool is coupled to the annuloplasty structure, a portion of the retraction member is disposed within a lumen of the delivery tool and the lock surrounds a portion of the retraction member.

[0134] For some applications, the lock is at least partially disposed within the recess when the delivery tool is coupled to the annuloplasty structure.

[0135] For some applications, the lock is disposed completely proximal to the recess when the delivery tool is coupled to the annuloplasty structure.

[0136] For some applications, the delivery tool includes a lock-ejector movable within a distal end portion of the delivery tool, and movement of the lock-ejector contacts and transitions the lock from an open state to a closed state to clamp onto a retraction member passing therethrough.

[0137] For some applications, the distal end portion of the delivery tool is shaped to define a sharp edge, and the retraction member is disposed adjacent the sharp edge such that movement of the lock-ejector against the sharp edge severs the retraction member extending through the lock.

[0138] According to some applications, a system and / or device is also provided that includes an implantable annuloplasty structure that includes a main body portion and a contraction member. The contraction member may be the same or similar to other contraction members described herein, and may, for example, have (1) a first portion extending along the longitudinal length of the main body portion of the annuloplasty structure, and (2) a second portion extending away from the main portion of the annuloplasty structure. The system and / or device may include a lock that can slide along the contraction member and that can be fixedly coupled to the contraction member to prevent movement of the contraction member. The lock may be formed to define a slit extending from a proximal surface of the lock toward a distal surface of the lock.

[0139] For some applications, the lock defines a lock cavity of the lock extending from a proximal opening in the lock toward a distal opening in the lock. The lock cavity can be configured to surround the retraction member. When the lock is compressed, the slit can enable the lock to close around the retraction member and thereby lock the lock to the retraction member.

[0140] For some applications, the annuloplasty structure comprises a complete annuloplasty ring structure, and in other cases the annuloplasty structure comprises a partial annuloplasty ring structure.

[0141] For some applications, the annuloplasty structure is shaped to define a recess that is sized to compress the lock when the lock is at least partially disposed within the recess.

[0142] For some applications, the lock may be disposed at least partially within the recess.

[0143] For some applications, the lock is configured to fit completely within the recess.

[0144] For some applications, the slit is shaped to define a distal portion that is wider than a proximal portion of the slit.

[0145] For some applications, the locking cavity is shaped to define a distal portion that is wider than a proximal portion of the locking cavity.

[0146] For some applications, the recess is shaped to define a proximal portion that is narrower than any other portion of the recess distal to the proximal portion.

[0147] For some applications, the lock is shaped to define a lock threaded portion, and the annuloplasty structure is shaped to define an annuloplasty structure threaded portion that is configured to engage the lock threaded portion.

[0148] For some applications, the annuloplasty structure includes a housing, and the housing is shaped to define a recess having a recess axis.

[0149] For some applications, the lock is shaped to define a lock threaded portion, and the housing is shaped to define an annuloplasty structure threaded portion configured to engage the lock threaded portion.

[0150] For some applications, the housing is shaped to define a constriction member lumen that is disposed at a non-zero angle relative to the axis of the recess.

[0151] For some applications, the housing is shaped to provide a contraction member lumen wall disposed along the contraction member lumen, and when the lock is disposed within the recess, the distal end of the lock is configured to squeeze a first portion of the contraction member against the contraction member lumen wall to lock the contraction member at least at the first compression point.

[0152] For some applications, the recess is shaped to define a recess distal tapered portion, and the lock is shaped to define a lock cavity of the lock and a lock distal tapered portion, 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 the retraction member. When the lock is disposed in the recess, the recess distal tapered portion can be configured to compress the lock distal tapered portion, which in turn is configured to squeeze a second portion of the retraction member within the lock cavity at the recess distal tapered portion so as to lock the retraction member at least at the second compression point.

[0153] For some applications, the system and / or apparatus further includes a delivery tool, the delivery tool and the retraction member being slidable relative to each other, the delivery tool being configured to deliver the annuloplasty structure to a valve annulus of the patient's heart.

[0154] For some applications, the delivery tool includes a knob coupled to a proximal portion of the retraction member, the knob configured to increase tension in the retraction member by pulling the retraction member proximally.

[0155] For some applications, the knob is fixedly coupled to the proximal portion of the retraction member.

[0156] For some applications, when the delivery tool is coupled to the annuloplasty structure, a portion of the retraction member is disposed within a lumen of the delivery tool and the lock surrounds a portion of the retraction member.

[0157] For some applications, the annuloplasty structure is shaped to define a recess sized to compress the lock when the lock is at least partially disposed within the recess, and the lock is at least partially disposed within the recess when the delivery tool is coupled to the annuloplasty structure.

[0158] For some applications, the annuloplasty structure is shaped to define a recess sized to compress the lock when the lock is at least partially disposed within the recess, and the lock is disposed completely proximal to the recess when the delivery tool is coupled to the annuloplasty structure.

[0159] For some applications, the delivery tool includes a lock-ejector movable within a distal end portion of the delivery tool, and movement of the lock-ejector contacts and transitions the lock from an open state to a closed state to clamp onto a retraction member passing therethrough.

[0160] For some applications, the distal end portion of the delivery tool is shaped to define a sharp edge, and the retraction member is disposed adjacent the sharp edge such that movement of the lock-ejector against the sharp edge severs the retraction member extending through the lock.

[0161] According to some applications, a method is also provided that includes advancing an implantable annuloplasty structure toward a patient's heart. The implantable annuloplasty structure can be the same or similar to other annuloplasty structures described herein or otherwise known, for example, having a body portion having a sidewall and a contraction member having (1) a first portion extending along a longitudinal length of the body portion of the annuloplasty structure, and (2) a second portion extending away from the body portion of the annuloplasty structure, the contraction member being configured to adjust a circumference of the annuloplasty structure.

[0162] The body portion of the annuloplasty structure may be shaped to define a recess having a recess axis, the recess extending from an opening in a first surface of a sidewall of the body portion toward an opposing second surface of the sidewall of the body portion, the sidewall of the body portion extending away from the recess along a longitudinal axis that is at a non-zero angle relative to the recess axis, the constriction member extending through the recess and extending away from the body portion of the annuloplasty structure via the recess; and

[0163] The method may further include locking the retraction member by sliding a lock along the retraction member to engage within a recess, the lock being fixedly coupled to the retraction member to prevent movement of the retraction member, the recess being shaped to facilitate fixed coupling of the lock to the retraction member.

[0164] For some applications, advancing includes advancing the annuloplasty structure while the lock is at least partially disposed within the recess.

[0165] For some applications, advancing includes advancing the annuloplasty structure when the lock is fully disposed proximal to the recess.

[0166] For some applications, locking the retraction member includes sliding the lock completely into the recess.

[0167] For some applications, the annuloplasty structure includes a complete annuloplasty ring structure or a partial annuloplasty ring structure.

[0168] For some applications, the lock is shaped to define a slit extending from a proximal surface of the lock toward a distal surface of the lock, the lock defining a lock cavity of the lock extending from a proximal opening in the lock toward a distal opening in the lock, the lock cavity being configured to surround the retraction member, and when the lock is disposed within the recess, the slit enables the lock to close around the retraction member and thereby lock the lock to the retraction member.

[0169] For some applications, the recess is sized to compress the lock when the lock is at least partially disposed within the recess, and locking includes positioning the lock at least partially within the recess to compress the lock.

[0170] For some applications, the locking cavity is shaped to define a distal portion that is wider than a proximal portion of the locking cavity.

[0171] For some applications, the recess is shaped to define a proximal portion that is narrower than any other portion of the recess distal to the proximal portion.

[0172] For some applications, advancing includes advancing the annuloplasty structure using a delivery tool, and the method further includes sliding the delivery tool and the contraction member relative to each other.

[0173] For some applications, advancing includes advancing the lock within a delivery tool, and locking includes sliding the lock using the delivery tool.

[0174] For some applications, the delivery tool includes a knob coupled to a proximal portion of the retraction member, and the method further includes increasing tension in the retraction member by pulling the retraction member proximally, using the knob.

[0175] For some applications, the knob is fixedly coupled to the proximal portion of the retraction member.

[0176] 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 on a retraction member passing therethrough by moving the lock-ejector to contact the lock and transition the lock from an open state to a closed state.

[0177] For some applications, the distal end portion of the delivery tool is shaped to define a sharp edge, the retraction member is disposed adjacent the sharp edge, moving the lock-ejector includes moving the lock-ejector against the sharp edge, and severing the retraction member extending through the lock by movement of the lock-ejector against the sharp edge.

[0178] The method can be performed in a procedure performed on a live animal or in a simulation / simulation procedure (e.g., on a cadaver, a cadaver heart, a simulator with a simulated heart, tissue, etc., an anthropomorphic phantom, etc.).

[0179] According to some applications, a method is also provided that includes advancing an implantable annuloplasty structure toward a patient's heart. The annuloplasty structure can be the same or similar to other annuloplasty structures described herein or otherwise known, and can, for example, include a body portion having a sidewall and a contraction member. The contraction member can have (1) a first portion extending along a longitudinal length of the body portion of the annuloplasty structure, and (2) a second portion extending away from the body portion of the annuloplasty structure, the contraction member being configured to adjust a circumference of the annuloplasty structure.

[0180] The method also includes locking the contraction member by sliding a lock along the contraction member, the lock being fixedly 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 of the lock 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. For some applications, when the lock is compressed, the slit enables the lock to close around the contraction member and thereby lock the lock to the contraction member.

[0181] For some applications, the annuloplasty structure includes a complete annuloplasty ring structure or a partial annuloplasty ring structure.

[0182] For some applications, the annuloplasty structure is shaped to define a recess sized to compress the lock when the lock is at least partially disposed within the recess, and locking the retraction member includes sliding the lock at least partially within the recess.

[0183] For some applications, advancing includes advancing the annuloplasty structure while the lock is at least partially disposed within the recess.

[0184] For some applications, advancing includes advancing the annuloplasty structure when the lock is fully disposed proximal to the recess.

[0185] For some applications, locking the retraction member includes sliding the lock completely into the recess.

[0186] For some applications, the recess is sized to compress the lock when the lock is at least partially disposed within the recess.

[0187] For some applications, the locking cavity is shaped to define a distal portion that is wider than a proximal portion of the locking cavity.

[0188] For some applications, the recess is shaped to define a proximal portion that is narrower than any other portion of the recess distal to the proximal portion.

[0189] For some applications, advancing includes advancing the annuloplasty structure using a delivery tool, and the method further includes sliding the delivery tool and the contraction member relative to each other.

[0190] For some applications, advancing includes advancing the lock within a delivery tool, and locking includes sliding the lock using the delivery tool.

[0191] For some applications, the delivery tool includes a knob coupled to a proximal portion of the retraction member, and the method further includes increasing tension in the retraction member by pulling the retraction member proximally, using the knob.

[0192] For some applications, the knob is fixedly coupled to the proximal portion of the retraction member.

[0193] 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 on a retraction member passing therethrough by moving the lock-ejector to contact the lock and transition the lock from an open state to a closed state.

[0194] For some applications, the distal end portion of the delivery tool is shaped to define a sharp edge, the retraction member is disposed adjacent the sharp edge, moving the lock-ejector includes moving the lock-ejector against the sharp edge, and severing the retraction member extending through the lock by movement of the lock-ejector against the sharp edge.

[0195] The method can be performed in a procedure performed on a live animal or in a simulation / simulation procedure (e.g., on a cadaver, a cadaver heart, a simulator with a simulated heart, tissue, etc., an anthropomorphic phantom, etc.).

[0196] According to some applications, a system and / or device is also provided that includes an implantable annuloplasty structure that includes a main body portion and a contraction member. The contraction member can be the same or similar to other contraction members described herein or otherwise known, and can, for example, have (1) a first portion extending along the longitudinal length of the main body portion of the annuloplasty structure, and (2) a second portion extending away from the main body portion of the annuloplasty structure.

[0197] The system and / or apparatus also includes at least one retraction member fastener configured to surround a retraction member, the retraction 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 retraction member passing therethrough, and (b) can be deflected to an open state through which the retraction member can move.

[0198] The system and / or device also includes a stopper and a contraction member cutting tool, the stopper being removably connected to the contraction member fastener and being configured to hold the contraction member fastener in an open state. The contraction 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 graspers, the one or more graspers being configured to pull the stopper proximally and remove the stopper from the contraction member fastener. For some applications, a portion of the contraction member passes through the static cutting element and through the dynamic cutting element, and once pulled proximally, the stopper 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 facilitate cutting the contraction member.

[0199] For some applications, the first cutting surface and the second cutting surface are each concave.For some applications, the first cutting surface and the second cutting surface are each diagonal.

[0200] For some applications, the tool is arranged such that the tool provides a safety mechanism whereby movement of the dynamic cutting element relative to the static cutting element is only possible if a stop is pushed against the dynamic cutting element.

[0201] For some applications, the system and / or apparatus further includes a housing that houses the fastener and the stopper, and the tool is coupled to the housing when the grasper grasps the stopper.

[0202] For some applications, the tool is configured to deliver the housing, fasteners, and stops to an implantable annuloplasty structure.

[0203] For some applications, an implantable annuloplasty structure includes a housing.

[0204] For some applications, the stopper is shaped to define an overhang, and the grasper is configured to grasp the overhang to initially couple the tool to the fastener.

[0205] For some applications, the system and / or device also includes an outer sleeve portion configured to surround the grasper to lock the grasper relative to the overhang.

[0206] According to some applications, a system and / or apparatus is also provided that includes a contraction member fastener configured to be fastened to a contraction member. For some applications, at least one contraction member fastener is configured to surround the contraction member. The contraction member fastener may include a clamping structure that (a) is biased toward assuming a closed state in which the clamping structure is configured to clamp onto the contraction member passing therethrough, and (b) can be deflected to an open state through which the contraction member can move.

[0207] The system and / or apparatus may include a stopper removably coupled to the retraction member fastener and configured to retain the retraction member fastener in an open state.

[0208] The system and / or device may include a contraction member cutting tool. The contraction member cutting tool may include a cutting element configured to cut the contraction member and one or more graspers configured to pull the stopper proximally and remove the stopper from the contraction member fastener. For some applications, once pulled proximally, the stopper contacts the cutting element and is configured to push against and move the cutting element to facilitate cutting of the contraction member by the cutting element.

[0209] For some applications, the tool is arranged such that the tool provides a safety mechanism whereby movement of the cutting element is only possible if a stop is pushed against the cutting element.

[0210] For some applications, the system and / or apparatus further includes a housing that houses the fastener and the stopper, and the tool is coupled to the housing when the grasper grasps the stopper.

[0211] For some applications, the system and / or apparatus also includes an implantable annuloplasty structure, and the tool is configured to deliver the housing, the fastener, and the stopper to the implantable annuloplasty structure.

[0212] For some applications, the systems and / or devices also include an implantable annuloplasty structure comprising the housing.

[0213] For some applications, the stopper is shaped to define an overhang, and the grasper is configured to grasp the overhang to initially couple the tool to the fastener.

[0214] For some applications, the system and / or device also includes an outer sleeve portion configured to surround the grasper to lock the grasper relative to the overhang.

[0215] According to some applications, a method is also provided, which includes threading a contraction member cutting tool along a contraction member, the contraction member cutting tool including a cutting element adjacent to the contraction member during the threading. The method may also include engaging the tool with a stopper, the stopper being removably coupled to a contraction member fastener surrounding a portion of the contraction member, the stopper being configured to hold the contraction member fastener in an open state.

[0216] For some applications, the method further includes using the tool to disengage the stopper from the contraction member fastener by pulling the stopper with the tool, and by pulling, bringing the stopper into contact with the cutting element and facilitating pushing the stopper against the cutting element, and by such pushing, facilitating moving the cutting element and thereby facilitating severing the contraction member by the cutting element.

[0217] For some applications, the tool is arranged such that the tool provides a safety mechanism whereby movement of the cutting element is only possible by pushing a stop against the cutting element.

[0218] For some applications, the method further includes a housing housing the fastener and the stopper, and the method includes coupling a tool to the housing by grasping the stopper with the tool.

[0219] For some applications, the method further includes using the tool to deliver the housing, the fastener, and the stopper to the implantable annuloplasty structure.

[0220] For some applications, coupling the tool to the housing includes coupling the tool to a housing coupled to an implantable annuloplasty structure.

[0221] For some applications, the stop is shaped to define an overhang, and engaging the tool with the stop includes initially coupling the tool to the fastener by grasping the overhang with the tool having a grasper.

[0222] For some applications, the method further includes locking the grasper relative to the overhang by fitting the outer sleeve portion over the grasper.

[0223] The method can be performed in a procedure performed on a live animal or in a simulation / simulation procedure (e.g., on a cadaver, a cadaver heart, a simulator with a simulated heart, tissue, etc., an anthropomorphic phantom, etc.).

[0224] According to some applications, a system and / or device is also provided, comprising: an implant comprising an implantable structure and a flexible, elongated contraction member extending away from the implantable structure; and a contraction member receiving tool comprising a handle portion comprising an outer shell, a tubular shaft at least partially disposed within the outer shell, and an inner shaft.

[0225] For some applications, the inner shaft (a) is partially disposed within a proximal longitudinal portion of the tubular shaft such that the inner shaft can slide axially relative to the tubular shaft, (b) is formed to define an inner shaft contraction member receiving channel, and (c) includes a lock configured to (i) allow the contraction member to slide relative to the inner shaft contraction member receiving channel when in an unlocked state, and (ii) lock the contraction member axially relative to the inner shaft when in a locked state.

[0226] For some applications, the system and / or device (e.g., in a handle) also includes a distal force applicator that (a) is at least partially disposed within a distal longitudinal portion of the tubular shaft and (b) is formed to define a distal force applicator retraction member receiving channel that allows the retraction member to slide therethrough.

[0227] For some applications, the system and / or device (e.g., in a handle) further includes: a spring disposed within the tubular shaft connecting the distal force applicator and the distal portion of the inner shaft; and a contraction-facilitating knob accessible from outside the outer housing.

[0228] For some applications, the handle portion is shaped to define a handle retraction member receiving channel from a distal end to a proximal end of the handle portion, the handle retraction member receiving channel including an inner shaft retraction member receiving channel and a distal force applicator retraction member receiving channel.

[0229] For some applications, the handle portion is configured such that when the retraction member is positioned to pass completely through the handle retraction member receiving channel and the lock is in a locked state, actuation of the retraction facilitation knob receives a continuous portion of the retraction member 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 directed force to the spring, which pushes the inner shaft proximally relative to the outer housing, and which pulls the retraction member proximally.

[0230] For some applications, the handle portion is configured such that when the contraction facilitation knob is actuated when the contraction member is set to completely pass through the handle contraction member receiving channel, the lock is in a locked state and the contraction member is tensioned: the spring pushes the inner shaft proximally relative to the outer shell to a lesser extent than the tubular shaft is proximally advanced relative to the outer shell, and the contraction member is pulled proximally by the inner shaft to increase the tension in the contraction member.

[0231] For some applications, the contraction facilitating knob is configured to be actuated by rotation thereof.

[0232] For some applications, the tubular shaft and the contraction facilitating knob are threadably coupled to one another, and the handle portion is configured such that actuation of the contraction facilitating knob rotates the tubular shaft to advance the tubular shaft proximally relative to the outer housing.

[0233] For some applications, the inner shaft partially protrudes out of the proximal end of the outer housing, and the tubular shaft and inner shaft together provide a non-electrical mechanical force gauge, wherein the relative axial position of the tubular shaft with respect to the inner shaft provides a visual indication of the measure of tension in the retraction member.

[0234] For some applications, the inner shaft is marked with a plurality of fiduciary markers disposed along the inner shaft to indicate a relative axial position of the tubular shaft with respect to the inner shaft.

[0235] 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 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.

[0236] 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 disposed at a predetermined relative axial position relative to the inner shaft, thereby limiting a maximum tension that the inner shaft can apply to the retraction member.

[0237] 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 disposed at a predetermined relative axial position relative to the inner shaft, thereby limiting a maximum tension that the inner shaft can apply to the retraction member.

[0238] For some applications, the pawl is coupled to the inner shaft in an axially fixed manner and is configured to move radially outward to engage the outer housing to axially lock the inner shaft relative to the outer housing.

[0239] For some applications, the tension limiting locking assembly also includes a plurality of indentations, the outer housing being shaped to define the plurality of indentations, the pawl being engageable with the indentations to axially lock the inner shaft relative to the outer housing, and the handle portion being arranged such that when the tubular shaft is disposed in a predetermined relative axial position relative to the inner shaft, a particular one of the indentations that engages the pawl depends on the relative axial position of the inner shaft relative to the outer housing.

[0240] 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 pawl axially locks the inner shaft relative to the outer housing.

[0241] For some applications, the tubular shaft includes one or more tracks extending alongside the longitudinal portion of the elongated opening and arranged to:

[0242] (a) preventing the pawl from axially locking the inner shaft relative to the outer housing when the tubular shaft is disposed distally in a predetermined relative axial position relative to the inner shaft, and

[0243] (b) allowing the pawl to axially lock the inner shaft when the tubular shaft is disposed in a predetermined relative axial position relative to the inner shaft.

[0244] 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 disposed 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, causes the pawl to disengage from the outer housing.

[0245] For some applications, the inner shaft partially protrudes out of the proximal end of the outer housing, and the tubular shaft and inner shaft together provide a non-electrical mechanical force gauge, wherein the relative axial position of the tubular shaft with respect to the inner shaft provides a visual indication of the measure of tension in the retraction member.

[0246] For some applications, the implantable structure includes an implantable annuloplasty structure.

[0247] For some applications, the implantable annuloplasty structure includes a flexible sleeve, and the contraction member extends along and away from the sleeve.

[0248] According to some applications, a system and / or apparatus is also provided, comprising: an implant including an implantable structure and a flexible, elongated contraction member extending away from the implantable structure; and a contraction member receiving tool. The contraction member receiving tool may include a handle portion, the handle portion (a) being shaped to define a handle contraction member receiving channel from a distal end to a proximal end of the handle portion, and (b) including: an outer housing; a non-electrical mechanical dynamometer; a lock; and a contraction facilitating knob accessible from outside the outer housing. The lock may be configured to (i) allow the contraction member to slide relative to the dynamometer when in an unlocked state, and (ii) axially lock the contraction member relative to an axially movable portion of the dynamometer, the axially movable portion of the dynamometer being axially movable relative to the outer housing, when in a locked state.

[0249] For some applications, the handle portion is configured such that when the retraction member is positioned completely through the handle retraction member receiving channel and the lock is in a locked state, actuation of the retraction facilitation knob causes the handle portion to receive a continuous portion of the retraction member by advancing the force gauge proximally relative to the outer housing so as to pull the retraction member proximally.

[0250] For some applications, the handle portion is configured such that when the contraction facilitation knob is actuated when the contraction member is positioned to completely pass through the handle contraction member receiving channel, the lock is in a locked state and the contraction member is tensioned, the contraction member is pulled proximally by the axially movable portion of the force gauge to increase the tension in the contraction member, and the force gauge is configured to provide a visual indication of the measure of the tension in the contraction member.

[0251] For some applications, the dynamometer includes a spring.

[0252] For some applications, the force gauge is configured such that the spring applies a proximally directed force to the axially movable portion of the force gauge.

[0253] For some applications, the handle portion also includes a tension limiting locking assembly that is configured to axially lock the axially movable portion of the dynamometer 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 dynamometer can apply to the contraction member.

[0254] According to some applications, a method is also provided, comprising: advancing an implantable structure of an implant and a flexible, elongated contraction member extending away from the implantable structure toward a heart of a patient; and threading a portion of the contraction member through a handle contraction member receiving channel of a handle portion of a contraction member receiving tool. The contraction member receiving tool can be the same or similar to other contraction member receiving tools described elsewhere herein, and can, for example, include 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 facilitating knob that is accessible from outside the outer housing.

[0255] The inner shaft can (a) be partially disposed within the proximal longitudinal portion of the tubular shaft so that the inner shaft can slide axially relative to the tubular shaft, (b) be formed to define an inner shaft contraction member receiving channel, and (c) include a lock configured to (i) allow the contraction member to slide relative to the inner shaft contraction member receiving channel when in an unlocked state, and (ii) lock the contraction member axially relative to the inner shaft when in a locked state.

[0256] The distal force applicator can be (a) at least partially disposed within a distal longitudinal portion of the tubular shaft, and (b) formed to define a distal force applicator contraction member receiving channel that allows the contraction member to slide therethrough, the handle contraction member receiving channel (a) extending from the distal end of the handle portion to the proximal end, and (b) including an inner shaft contraction member receiving channel and a distal force applicator contraction member receiving channel.

[0257] A spring may be disposed within the tubular shaft, connecting the distal force applicator and the distal portion of the inner shaft.

[0258] The method also includes transitioning the lock from an unlocked state to a locked state.

[0259] For some applications, the method includes then, actuating a contraction facilitation 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 directed 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 facilitation knob to increase the tension in the contraction member by the inner shaft pulling the contraction member proximally caused by the spring pushing the inner shaft proximally relative to the outer housing (the degree of advancement is less than the proximal advancement of the tubular shaft relative to the outer housing).

[0260] For some applications, actuating the contraction facilitating knob includes rotating the contraction facilitating knob.

[0261] For some applications, the tubular shaft and the contraction facilitating knob are threadably coupled to one another, and the handle portion is configured such that actuation of the contraction facilitating knob rotates the tubular shaft to advance the tubular shaft proximally relative to the outer housing.

[0262] For some applications, the inner shaft partially protrudes beyond the proximal end of the outer housing, the tubular shaft and the inner shaft together provide a non-electrical mechanical 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, and the method also includes viewing the visual indication.

[0263] For some applications, the inner shaft is marked with a plurality of fiducial markers disposed along the inner shaft to indicate a relative axial position of the tubular shaft with respect to the inner shaft.

[0264] 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 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.

[0265] 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 disposed at a predetermined relative axial position relative to the inner shaft, thereby limiting a maximum tension that the inner shaft can apply to the retraction member.

[0266] 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 disposed at a predetermined relative axial position relative to the inner shaft, thereby limiting a maximum tension that the inner shaft can apply to the retraction member.

[0267] For some applications, the pawl is coupled to the inner shaft in an axially fixed manner and is configured to move radially outward to engage the outer housing to axially lock the inner shaft relative to the outer housing.

[0268] For some applications, the tension limiting locking assembly also includes a plurality of indentations, the outer housing being shaped to define the plurality of indentations, the pawl being engageable with the indentations to axially lock the inner shaft relative to the outer housing, and the handle portion being arranged such that when the tubular shaft is disposed in a predetermined relative axial position relative to the inner shaft, a particular one of the indentations that engages the pawl depends on the relative axial position of the inner shaft relative to the outer housing.

[0269] 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 pawl axially locks the inner shaft relative to the outer housing.

[0270] For some applications, the tubular shaft includes one or more tracks extending alongside the longitudinal portion of the elongated opening and arranged to:

[0271] (a) preventing the pawl from axially locking the inner shaft relative to the outer housing when the tubular shaft is disposed distally in a predetermined relative axial position relative to the inner shaft, and

[0272] (b) allowing the pawl to axially lock the inner shaft when the tubular shaft is disposed in a predetermined relative axial position relative to the inner shaft.

[0273] 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 disposed 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, causes the pawl to disengage from the outer housing.

[0274] For some applications, the inner shaft partially protrudes beyond the proximal end of the outer housing, the tubular shaft and the inner shaft together provide a non-electrical mechanical 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, and the method also includes viewing the visual indication.

[0275] For some applications, the implantable structure includes an implantable annuloplasty structure, and advancing the implantable structure includes advancing the implantable annuloplasty structure toward the heart.

[0276] For some applications, the implantable annuloplasty structure includes a flexible sleeve, and the implantable annuloplasty structure and the contraction member are advanced toward the heart such that the contraction member extends along and away from the sleeve.

[0277] According to some applications, a method is also provided, comprising: advancing an implantable structure of an implant and a flexible, elongated contraction member extending away from the implantable structure toward a patient's heart; and passing a portion of the contraction member through a handle contraction member receiving channel of a handle portion of a contraction member receiving tool.

[0278] The contraction member receiving tool can be the same or similar to other contraction member absorbing tools described elsewhere herein or otherwise known. For example, in some applications, the contraction member receiving tool includes an external housing, a non-electrical mechanical dynamometer, a lock, and a contraction facilitating knob. The lock can be configured to (i) allow the contraction member to slide relative to the dynamometer when in an unlocked state, and (ii) axially lock the contraction member relative to an axially movable portion of the dynamometer when in a locked state, the axially movable portion of the dynamometer being axially movable relative to the external housing. The contraction facilitating knob is accessible from the outside of the external housing.

[0279] The method further includes transitioning the lock from an unlocked state to a locked state; and then actuating the retraction facilitation knob to cause the handle portion to receive a continuation of the retraction member by advancing the dynamometer proximally relative to the outer housing to pull the retraction member proximally.

[0280] The method may thereafter include, once the contraction member is tensioned, actuating a contraction facilitation knob to increase tension in the contraction member by pulling the contraction member proximally by an axially movable portion of the dynamometer, and observing a visual indication of the measure of tension in the contraction member provided by the dynamometer.

[0281] For some applications, the dynamometer includes a spring.

[0282] For some applications, the force gauge is configured such that the spring applies a proximally directed force to the axially movable portion of the force gauge.

[0283] For some applications, the handle portion also includes a tension limiting locking assembly that is configured to axially lock the axially movable portion of the dynamometer 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 dynamometer can apply to the contraction member.

[0284] The method can be performed in a procedure performed on a live animal or in a simulation / simulation procedure (e.g., on a cadaver, a cadaver heart, a simulator with a simulated heart, tissue, etc., an anthropomorphic phantom, etc.).

[0285] According to some applications, a system and / or apparatus is also provided that can include an implantable annuloplasty structure (e.g., an annuloplasty ring structure, a closed annuloplasty structure, a closed annuloplasty ring structure, an open annuloplasty structure, a partial annuloplasty ring structure, or other annuloplasty device). The implantable annuloplasty structure can include a body portion and a contraction member that extends at least partially along a longitudinal length of the body portion of the annuloplasty structure. The implantable annuloplasty structure can be the same or similar to other annuloplasty structures described elsewhere herein.

[0286] The system and / or device may also include a contraction member receiving tool. The contraction member receiving tool may be the same or similar to other contraction member absorption tools described elsewhere herein. The contraction member receiving tool may include one or more tubes (e.g., one tube, a main tube and a secondary tube, etc.). At least one tube has a lumen configured to allow the contraction member to pass therethrough. The tube may be flexible, semi-rigid or rigid. The contraction member receiving tool may also include a contraction member snare. The contraction member snare may include a distal snare portion and an elongated flexible body portion coupled to the distal snare portion. The distal snare portion may be configured to trap a portion of the contraction member and pull it into the lumen. The distal snare portion may be configured to pull a portion of the contraction member through some of the lumen or through the entire length of the lumen (e.g., from one end to the other). The contraction member snare may include a wire containing stainless steel. The lumen of the tube may be sized to maintain the connection between the distal snare portion and the contraction member.

[0287] The contraction member receiving tool may include a handle portion, and the tube may be connected to the handle portion. The handle portion may include a contraction member receiving device, which is configured to receive a continuous portion of the contraction member. The handle portion may also include a tensiometer, which is configured to measure the degree of tension of the contraction member. The contraction member receiving device can be actuated to increase the tension of the contraction member. The contraction member receiving device may optionally include a wheel with a groove, which is configured to couple the contraction member to the wheel. The groove may be shaped to receive a middle portion of the contraction member.

[0288] The distal snare portion may include a flexible ring. The lumen may be configured to collapse the flexible ring 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.

[0289] The distal end portion of the retraction member receiving tool may be shaped to define a sharp edge, and the retraction member receiving tool may be configured to position the retraction member adjacent the sharp edge such that the sharp edge can sever the retraction member.

[0290] The contraction member receiving tool may include a contraction member fastener disposed within a distal end portion of the contraction member receiving tool. The contraction member fastener may include a clamping structure. The clamping structure may be biased toward assuming a closed state or closed position, and in the closed state / position, the clamping structure may be configured to clamp on the contraction member passing therethrough. The clamping structure may also be configured so that it can be deflected to an open state or open position, wherein in the open state / position, the contraction member can move therethrough. The contraction member receiving tool may also include a stopper that is removably coupled to the contraction member fastener and is configured to hold the contraction member fastener in the open state / position.

[0291] The distal snare portion, the portion of the contraction member, and the clamping structure can be configured and sized to pass distally through the contraction member fastener and the clamping structure in the open state / position. The distal snare portion can be adapted to capture and pull the portion of the contraction member proximally through the contraction member fastener and the clamping structure, and through the alignment port in the distal end portion of the contraction member receiving tool.

[0292] The retraction member receiving tool may include a fastener-ejector that is movable within a distal end portion of the retraction member receiving tool, and the fastener-ejector may be configured such that movement of the fastener-ejector contacts the retraction member fastener and the clamping structure and may convert it from an open state / position to a closed state / position to clamp on the retraction member as the retraction member passes therethrough. The fastener-ejector may be coupled to a stopper and may be configured to move a stopper that is removably coupled to the fastener. The distal end portion of the retraction member receiving tool may be shaped to define a sharp edge, and the retraction member receiving tool may be configured to position the retraction member adjacent to the sharp edge such that movement of the fastener-ejector against the sharp edge severs the retraction member after or near the retraction member extends through the fastener.

[0293] The various apparatus, systems, methods, etc. described above may be combined with and / or replace various features and components of other embodiments described elsewhere herein.

[0294] The present invention will be more fully understood from the following detailed description of embodiments of the present invention when read in conjunction with the accompanying drawings, in which: BRIEF DESCRIPTION OF THE DRAWINGS

[0295] Figure 1 to Figure 2 is a schematic diagram of an example of a multi-component tubular system for delivering and anchoring an implant and for controlling the relative spatial orientation of components of a catheter system;

[0296] FIG. 3A to FIG. 3I is a schematic diagram of an exemplary procedure for implanting an annuloplasty structure to repair a mitral valve;

[0297] FIG. 4A to FIG. 4B is a schematic diagram of an exemplary retraction member receiving tool, the retraction member receiving tool being configured to retract FIG. 3A to FIG. 3I the constriction member of the annuloplasty structure and cutting off any excess portion of the constriction member;

[0298] FIG. 5A to FIG. 5D yes FIG. 4A to FIG. 4B A schematic diagram of an exemplary contraction member receiving tool for receiving a contraction member;

[0299] FIG. 6A to FIG. 6B yes FIG. 4A to FIG. 4B A schematic diagram of an exemplary contraction member receiving tool for receiving a contraction member to contract an annuloplasty structure coupled to the contraction member;

[0300] 7A to 7E yes FIG. 4A to FIG. 4B Schematic diagram of an exemplary contraction member receiving tool for locking and securing an annuloplasty structure in its contracted state and subsequently cutting off excess portions of the contraction member;

[0301] FIG. 8A to FIG. 8D is a schematic diagram of an example of a system for constricting a patient's annulus using an annuloplasty structure including a housing housing a constriction member fastener;

[0302] 9A to 9D is a schematic diagram of an exemplary retracting member receiving tool for locking and securing a FIG. 8A to FIG. 8D annuloplasty structure, and subsequently cutting off the excess portion of the constriction member;

[0303] FIG. 10A to FIG. 10B is a schematic diagram of an example of a contraction member receiving tool that can be used to engage a contraction member and cut off any excess portion of the contraction member;

[0304] FIG. 11A to FIG. 11C is a schematic diagram of an example of a contraction member receiving tool for locking and securing an annuloplasty structure in its contracted state and subsequently cutting off excess portions of the contraction member;

[0305] FIG. 12A to FIG. 12C is a schematic diagram of an example of a system including an exemplary annuloplasty structure including a sleeve, a constriction member, and a lock;

[0306] FIG. 13A to FIG. 13C is a schematic diagram of an example of a system including an exemplary annuloplasty structure including a sleeve, a constriction member, and a lock;

[0307] Fig.14is a schematic diagram of an exemplary lock that may be used to lock the perimeter of an annuloplasty structure;

[0308] FIG. 15A to FIG. 15C is a schematic diagram of an example of a system including an exemplary annuloplasty structure including a sleeve, a constriction member, and a lock;

[0309] Fig.16 is a schematic diagram of an example of a system including an exemplary annuloplasty structure including a sleeve, a constriction member, and a lock;

[0310] Fig.17 is a schematic diagram of an example of a system including an exemplary annuloplasty structure including a sleeve, a constriction member, and a lock;

[0311] Fig.18 is a schematic diagram of an example of a system for constricting a patient's annulus using an annuloplasty structure including a housing housing a constriction member fastener;

[0312] FIG. 19A to FIG. 19B is a schematic diagram of an example of a system for constricting a patient's annulus using an annuloplasty structure including a housing housing a constriction member fastener;

[0313] FIG. 20A to FIG. 20F is a schematic diagram of an example of a constriction member containment and constriction member cutting tool for use with an annuloplasty structure including a housing that houses a constriction member fastener;

[0314] FIG. 21A to FIG. 21B According to some applications FIG. 20A to FIG. 20F Schematic diagram of an example of a contraction member receiving tool of a multi-component tubular system prior to insertion of a flexible elongated contraction member;

[0315] FIG. 22A to FIG. 22B According to some applications FIG. 21A to FIG. 21B A schematic diagram of a contraction member receiving tool after insertion of a flexible elongated contraction member;

[0316] FIG. 23A to FIG. 23B , 24A to Fig. 24B and 25A to Fig.25B According to some applications FIG. 21A to FIG. 21B A schematic diagram of a retraction member receiving a tool after successive levels of actuation of a retraction facilitating knob of the tool; and

[0317] FIG. 26A to FIG. 26B According to some applications FIG. 21A to FIG. 21B A schematic diagram of a portion of the outer housing and tubular shaft of the retraction member housing the tool. DETAILED DESCRIPTION

[0318] Reference now Figure 1 to Figure 2 , which is a schematic diagram of an example of a multi-component tubular system 10, which provides one or more rotationally controlled steering catheters configured to deliver an implant to a patient's heart. System 10 provides an implant delivery tool. System 10 may include a first outer catheter 12, which includes a sheath configured to be advanced through the patient's vascular system. For some applications, outer catheter 12 includes a sheath configured to be advanced toward the atrial septum of the patient's heart through the femoral artery. The distal steerable end portion of outer 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 to be advanced through the lumen of outer catheter 12. Outer catheter 12 provides a first coupling 152 (e.g., slit 52) ​​at its distal end portion (e.g., a portion of catheter 12 near the steerable distal end portion). The guide catheter 14 may include a second coupling 154 (e.g., a push-on coupling 54) coupled to a displaceable protrusion 56 coupled to the base. As described herein, the push-on coupling 54 (or second coupling 154) is configured to protrude within the slit 52 (or first coupling 152). Thus, the slit 52 defines a second coupling receiving element.

[0319] In some embodiments, the first coupling member 152 of the catheter 12 defines a longer coupling member and the second coupling member 154 of the catheter 14 defines a shorter coupling member. The first coupling member 152 and the second coupling member 154 of the outer catheter 12 and the guide catheter 14 respectively enable the guide catheter 14 to be axially advanced and rotationally moved through the lumen of the outer catheter 12 until the engagement member 54 of the catheter 14 is aligned and engaged with the slit 52 of the catheter 12, as will be described below. Figure 1 As shown in cross-section AA of FIG. 1 , the guide catheter 14 is configured to be concentrically disposed within the lumen of the outer catheter 12. In some embodiments, the catheter 12 provides a shorter coupling member, while the catheter 14 provides a longer coupling member. For example, the catheter 14 can be shaped to provide a slit 52, and the catheter 12 can include a coupling member 54 configured to engage the slit 52 of the catheter 14.

[0320] As shown in the exploded view of view B, the first coupling member 152 can be shaped to limit the slit 52. For some applications, as shown in the figure, the slit 52 is provided by a metal frame 50. The metal frame 50 can have a length L22 of, for example, 7mm to 15mm (for example, 13mm). For this application, a slit is formed in the material of the conduit 12 (for example, by forming a slit in the polymer material of the conduit 12 during the manufacture of the conduit 12), and the framework 50 is connected to the conduit 12. The second coupling member 154 may include a coupling member 54, which may include a projection at the distal portion of a displaceable protrusion 56 disposed at the base of the coupling member 54. The base of the coupling member 54 may be shaped to limit the slit 57 forming the protrusion 56. When a force is applied to it, the coupling member 54 is pressable, and the protrusion 56 facilitates the coupling member 54 to move in response to the force applied to the coupling member 54 and in the case of not being applied to the force of the coupling member. For some applications, during manufacture of catheter 14 , catheter 14 is manipulated to couple engagement member 54 and protrusion 56 thereto, such as engagement member 54 and protrusion 56 being embedded within a polymer of catheter 14 .

[0321] Although the slit 52 and the push-fit joint 54 are shown as being located on the outer catheter 12 and the guide catheter 14 at the distal portions of the catheters 12 and 14, respectively, the slit 52 and the joint 54 may be provided along any suitable portion of the catheters 12 and 14, respectively (e.g., the respective proximal portions of the catheters 12 and 14).

[0322] The first coupling member 152 and the second coupling member 154 can be respectively disposed on any standard conduit. That is, the coupling member 152 includes a frame 50 that can be coupled to the outer surface of any standard conduit (in which case a corresponding slit will be formed in the standard conduit). In addition, the coupling member 154 can be coupled to any standard conduit by coupling the base portion of the coupling member 154 to the standard conduit. The standard conduit will be appropriately adjusted to accommodate the displacement of the protrusion 56 and the engaging member 54 in response to the thrust applied to the engaging member 54.

[0323] Figure 2 An exemplary concentric relationship between the components of the tubular system 10 is shown (in Figure 2). As described above, the distal end portion of the outer catheter 12 is manipulable. The distal end portion of the outer catheter 12 may include a pull ring 11, which is connected to two or more steering wires or pull wires 29a and 29b, which are disposed in corresponding secondary lumens within the wall of the catheter 12 (as shown in section AA). As shown in the exploded view, the guide catheter 14 may be configured to be concentrically disposed within the lumen of the catheter 12. As described above, the distal end portion of the guide catheter 14 is manipulable. The distal end portion of the catheter 14 may include a pull ring 13, which is connected to two or more pull wires 31a and 31b, which are disposed in corresponding secondary lumens within the wall of the catheter 14 (as shown in sections AA and BB).

[0324] The guide catheter 14 can be manipulated to a desired spatial orientation to facilitate advancement and implantation of the implant into the patient's body cavity. As shown, the implant includes an annuloplasty structure 222 (e.g., an annuloplasty ring structure, a closed annuloplasty ring structure, a closed annuloplasty ring structure, an open annuloplasty structure, a partial annuloplasty ring structure, etc.), which includes a flexible sleeve 26 (e.g., Figure 2 ). The sleeve 26 may include a braided fabric mesh, such as DACRON (TM). The sleeve 26 may be configured to be placed only partially around the heart valve annulus (i.e., in a C-shape), and once anchored in place, the sleeve is contracted to circumferentially tighten the valve annulus. However, the ring structure may also be configured to be placed completely around the valve annulus. In order to tighten the valve annulus, the annuloplasty structure or annuloplasty ring structure 222 includes a flexible, elongated contraction member 226 extending along the sleeve 26. The elongated contraction member 226 may include a wire, a band, a rope, or a strap, which may include one or more of a variety of materials, such as a flexible and / or superelastic material, such as nitinol, polyester, stainless steel, or cobalt-chromium alloy. For some applications, the wire includes a radiopaque material. For some applications, the contraction member 226 includes a braided polyester suture (e.g., Ticron). For some applications, the contraction member 226 is coated with polytetrafluoroethylene (PTFE). For some applications, retraction member 226 includes a plurality of wires that are intertwined to form a rope structure.

[0325] For applications in which the system 10 is used to deliver an implant to a patient's mitral valve, the outer catheter 12 may be configured for initial advancement through the patient's vasculature until the distal end 102 (which may be the most distal end or tip) of the catheter 12 is positioned in the left atrium. The distal steerable end portion of the catheter 12 is then manipulated so that the distal end 102 of the catheter 12 is positioned within the left atrium in a desired spatial orientation. The manipulation procedure may be performed with the aid of imaging, such as fluoroscopy, transesophageal echo, and / or echocardiography. After manipulating the distal end portion of the catheter 12, the guide catheter 14 (which houses the annuloplasty structure 222) is advanced through the catheter 12 to facilitate delivery and implantation of the structure 222 along the annulus of the mitral valve. During delivery, at least a portion of the steerable distal end portion of the catheter 14 may be exposed from the distal end 102 of the catheter 12 and thus freely manipulated toward the annulus of the mitral valve, as described below.

[0326] In addition, the system 10 includes an attachment mechanism (e.g., anchors, adhesives, clamps, clamps, fasteners, etc.), such as a plurality of anchors 32, which can be, for example, between about 5 and about 20 anchors, such as about 10 or about 16 anchors. Each anchor 32 can include a tissue engaging element 60 (e.g., a threaded tissue engaging element) and a tool coupling head 62 fixed to one end of the tissue engaging element. An anchor 32 is preferably a plurality of anchors 32, which can be, for example, between about 5 and about 20 anchors, such as about 10 or about 16 anchors. Figure 2 2 is shown as a deployment element 38 of a rotary anchor driver 36 reversibly coupled to an anchor deployment manipulator 61. When the cannula 26 is positioned along the annulus of the 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. Insertion of the anchors into the cannula and deployment of the anchors into the heart tissue will be described in detail below.

[0327] Anchor 32 can include a biocompatible material, such as stainless steel 316LVM. For some applications, anchor 32 includes Nitinol. For some applications, anchor 32 is fully or partially coated with a non-conductive material.

[0328] like Figure 2 As shown, the deployment manipulator 61 includes an anchor driver 36 and a deployment element 38 .

[0329] like Figure 2 As shown in the exploded view of FIG. 1 , sleeve 26 is disposed within the lumen of guide catheter 14. A force is applied to the proximal end of sleeve 26 by the distal end of reference force tube 19. As shown, implant separation channel 18 can be advanced within the lumen of reference force tube 19 and through the lumen of sleeve 26 so that the portion of channel 18 disposed within the sleeve is coaxial with the sleeve. Figure 1 As shown in the enlarged image of , the distal end 17 of the implant separation channel 18 is arranged to contact the inner wall of the sleeve 26 at its distal end. In addition, the distal end portion of the channel 18 includes a radiopaque marker 1018. As shown, the tube 19 and the sleeve 26 are longitudinally and coaxially arranged relative to each other.

[0330] An anchor driver 36 can be advanced within the channel 18. For some applications, the system 10 includes a plurality of anchor drivers 36, each driver coupled to a respective anchor 32. Each driver 36 can be advanced within the channel 18 to advance and implant the anchor 32 in the tissue. After implanting the anchor 32, as described herein, the anchor 32 is detached from the driver 36, and the driver 36 is removed from the channel 18. Subsequently, a new driver 36 coupled to another anchor 32 is then advanced within the channel 18.

[0331] As will be described below, the first anchor 32 is configured to be deployed into the heart tissue through the wall of the sleeve when the sleeve 26 is positioned along the annulus of the valve. After the deployment of the first anchor, the distal portion of the sleeve 26 slides distally away from a portion of the implant separation channel 18. In order to cause the sleeve 26 to separate 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 a manner such that the distal end of the tube 19 provides a reference force to the sleeve 26 to facilitate the release of the continuous portion of the sleeve 26 from around the channel 18. The channel 18 is then positioned at a continuous position within the lumen of the sleeve 26, while the tube 19 and / or catheter 14 is manipulated toward the continuous position along the annulus of the valve (as will be described below). Therefore, the continuous portion of the sleeve 26 provides a free lumen for the advancement of the continuous anchor 32 and the deployment of the anchor through the wall of the sleeve at its continuous portion. This release of successive portions of the cannula 26 creates distances between successive anchors deployed from within the lumen of the cannula 26 .

[0332] For some applications, the cannula 26 includes a plurality of radiopaque markers 25 positioned at corresponding longitudinal locations along the cannula. The markers can provide an indication in a radiographic image, such as a fluoroscopic image, of how many cannulas are deployed at any given point during the implantation procedure so that the desired distance between anchors 32 can be set along the cannula. For some applications, the markers include radiopaque ink.

[0333] 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 apart 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 to be equal to the desired distance between adjacent anchors. For example, the markers may include a first marker, a second marker, and a third marker, the first marker and the second marker are adjacent, and the second marker and the third marker are adjacent, and the distance between the proximal edge and / or distal edge of the first marker and the second marker is equal to the corresponding distance between the proximal edge and / or distal edge of the second marker and the third marker. For example, the 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 (for example, if the distance is 6 mm and the length is 2 mm, the length of the longitudinal gap between adjacent markers is 4 mm).

[0334] Each anchor 32 can be coupled to a deployment element 38 of an anchor driver 36. The anchor driver 36 includes an elongated tube having at least one flexible distal end portion. The elongated tube of the driver 36 extends within the lumen of the channel 18 through the system 10 toward the proximal end of the proximal handle portion 101 of the system 10. The tube of the anchor driver 36 provides a lumen for slidably advancing an elongated rod 130 therethrough. The rod 130 facilitates locking and unlocking of the anchor 32 with the deployment element 38, as described below. Figure 2 As shown in section EE of FIG. 1 , the proximal end of the rod 130 is coupled to a component of the anchor release mechanism 28 at the proximal end of the system 10. The mechanism 28 includes a housing 135 and a finger joint 131 coupled to the proximal end of the rod 130. The finger joint 131 is coupled to the housing 135 ( Figure 2 EE). The proximal end of the tube of the anchor driver 36 is coupled to the housing 135. As described below, when the finger engagement member 131 is pulled proximally, the user (e.g., a physician, a healthcare professional, etc.) releases the anchor 32 from the deployment element 38, thereby pulling the rod 130 proximally.

[0335] For some applications, the anchor driver 36 (e.g., its rotation and / or proximal-distal movement, and / or release of the anchor 32) is electronically controllable, such as by using an in vitro controller and / or electric motor coupled to the anchor driver and / or the proximal end of the housing 135.

[0336] The proximal handle portion 101 can be supported by a bracket having support legs 91 and a handle sliding track 90. ​​The handle portion 101 includes an outer catheter handle 22, a guide catheter handle 24, an implant manipulation handle 126, and an anchor release mechanism 28. The handle 22 is coupled to the proximal end of the outer catheter 12. The handle 24 is coupled to the proximal portion of the guide catheter 14. The handle 126 is coupled to the proximal portion of the reference force tube 19, and linear movement of the handle 126 relative to the handle 24 causes the reference force tube 19 (and thereby generally the 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 driver 36. The relative positioning of each of the concentrically disposed components of the system 10 is described in detail below. Figure 2 The exploded view and sections AA, BB, CC and DD are shown.

[0337] The support supporting the proximal handle portion 101 can be moved distally and proximally to control the position of the entire multi-component system 10, in particular to adjust the distance between the distal end 102 of the catheter 12 and the atrial septum. The handle 22 includes a manipulation knob 210, which is connected to the pull wires 29a and 29b disposed in the corresponding secondary lumens in the wall of the outer catheter 12. The rotation of the knob 210 adjusts the tension of the wires 29a and 29b, which in turn applies force to the pull ring 11 at the distal end portion of the outer catheter 12. This force manipulates the distal end portion of the catheter 12 in 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 ring of the valve (e.g., in a direction from the atrial septum toward the surrounding wall of the atrium). For some applications, the distal end portion of the catheter 12 can be preformed to point downward to the valve. For other applications, the distal end portion of the catheter 12 can be pulled to present an orientation in which the distal end portion points downward to the valve. For some applications, the distal end portion of catheter 12 is not configured to point downwardly toward the valve.

[0338] 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 guide 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 guide catheter 14 relative to the distal end 102 of the outer catheter 12. The handle 24 can include a steering knob 214 that is coupled to the pull wires 31a and 31b disposed within respective secondary lumens in the wall of the guide catheter 14. Rotation of the knob 214 adjusts the degree of tension of the wires 31a and 31b, which in turn applies a force to the pull ring 13 at the distal end portion of the guide catheter 14. This force steers the distal end portion of the catheter 14 downwardly and toward the annulus of the heart valve in a second plane within the atrium of the patient's heart. As described below, the distal end portion of the guide catheter 14 can be steered within a second plane that is substantially perpendicular relative to the first plane in which the distal end portion of the outer catheter 12 is steered.

[0339] Combined manipulation of the respective distal end portions of catheters 12 and 14 guides the sheath 26 downward toward the annulus via manipulation of the distal end portion of catheter 12 (e.g., via manipulation of the distal end portion of catheter 14) and along the periphery of the annulus (e.g., from the posterior portion of the valve to the anterior portion of the valve, or vice versa).

[0340] For some applications, handle 22 may be tilted by a user (eg, an operating physician, etc.) to further adjust the position of the distal end of catheter 12 .

[0341] For some applications, handle 22 includes an indicator that indicates the degree of deflection (e.g., bend) of the distal end portion of catheter 12 that has been produced using knob 210. For some applications, handle 24 includes an indicator that indicates the degree of deflection (e.g., bend) of the distal end portion of catheter 12 that has been produced using knob 214.

[0342] As described herein, the first coupling 152 and the second coupling 154 (e.g., the slit 52 and the engagement member 54, respectively) of the outer catheter 12 and the guide catheter 14, respectively, provide a controlled maneuverable system, wherein during manipulation and bending of the distal end portion of the guide catheter 14, the distal end portion of the outer catheter 12 is maintained in its maneuvering configuration or its spatial orientation without substantially affecting the manipulation or bending of the distal end portion of the guide catheter 14. Thus, the first coupling 152 and the second coupling 154, respectively, minimize the effect of the distal end portion of the outer catheter 12 on the manipulation and bending of the catheter 14. That is, the first coupling 152 and the second coupling 154 of the outer catheter 12 and the guide catheter 14, respectively, jointly define a relative spatial orientation control device that rotationally locks the relative spatial orientation of the maneuverable distal end portion and the bending portion of the outer catheter 12 relative to the maneuverable distal end portion and the bending portion of the guide catheter 14.

[0343] Retraction member 226 exits the lumen in the wall of guide catheter 14 at the portion of handle portion 101 located between handles 22 and 24 .

[0344] The handle 126 can be connected to the track 90 via a second mounting member 93. The mounting member 93 can slide proximally and distally along the track to control the axial position of the reference force tube 19 and at least the proximal portion of the sleeve 26 relative to the guide catheter 14. The mounting member 93 can slide via a control knob. For example, the control knob of the mounting member 93 can control the proximal and distal axial movement of the tube 19 and at least the proximal portion of the sleeve 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, during the deployment of the anchor 32 from the lumen of the sleeve 26, this movement of the tube 19 and at least the proximal portion of the sleeve 26 causes the proximal portion of the sleeve 26 to move toward the desired portion of the tissue of the annulus of the valve, as described below.

[0345] As described above, to separate the cannula 26 from a portion of the outer surface of the channel 18, (1) the channel 18 can be pulled proximally while (2) holding the reference force tube 19 in place. The proximal end of the channel 18 can be coupled to a knob 94 that adjusts the axial position of the channel 18 proximally and distally relative to the reference force tube 19 and the cannula 26.

[0346] The handle portion 101 may include a release decision facilitating member 127, such as a latch or a button, which automatically engages when a given length of the cannula 26 has been advanced out of the channel 18 (e.g., when the channel 18 is in a given position relative to the tube 19); typically just before the cannula 26 is completely separated from the channel 18. The engagement of the member 127 inhibits the proximal movement of the channel 18 relative to the tube 19, thereby reducing (e.g., preventing) the possibility of accidental release of the cannula 26. In order to release the cannula 26 (e.g., separate the channel 18 from the cannula), the user (e.g., the operating physician) must disengage the member 127, such as by pushing a button, before continuing to withdraw the channel 18 proximally. When engaged, the member 127 can also inhibit the distal movement of the channel 18 relative to the tube 19.

[0347] The handle portion 101 (including the handles 22, 24 and 126 and the anchor release mechanism 28) can have a length L1 between 65 cm and 85 cm (e.g., 76 cm). As shown, a majority of the main body portion of the outer catheter handle 22 can be disposed at a non-zero angle relative to the longitudinal axis 7 of the plurality of components of the system 10. A manipulation mechanism provided by the handle 22 for manipulating the distal end portion of the catheter 12 is disposed within a portion of the handle 22 disposed at a non-zero angle relative to the axis 7. The handle 22 includes a straight tubular portion 21 that is coaxially disposed longitudinally along the axis 7 and coaxially relative 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 outer catheter 12. The tubular portion 21 has a length L24 between 7 cm and 11 cm (e.g., 7 cm). This spatial orientation of the majority of the handle 22 at an angle relative to the axis 7 reduces the overall functional length of the handle portion 101 .

[0348] Reference now FIG. 3A to FIG. 3I , which is a schematic diagram of an example of a procedure for implanting an annuloplasty ring structure 222 (e.g., an annuloplasty ring structure, a closed annuloplasty ring structure, an open annuloplasty ring structure, a partial annuloplasty ring structure, etc.) to repair a mitral valve 230. The procedure is one example of a procedure that may be performed using the system 10.

[0349] An annuloplasty structure or annuloplasty ring structure 222 can be used to repair a dilated annulus of an atrioventricular valve, such as a mitral valve 230. For some applications, the annuloplasty structure is configured to be placed only partially around the annulus (e.g., in a C-shape) and, once anchored or otherwise secured in place, is contracted to circumferentially tighten the annulus. For some applications, the annuloplasty structure is configured to be placed completely around the annulus (e.g., in a closed shape, such as a circle, an ellipse, a D-shape, etc.) and, once secured in place, is contracted to circumferentially tighten the annulus. The annuloplasty structure may include a flexible sleeve 26. The annuloplasty structure may also include and / or be used with attachment devices (e.g., anchors, fasteners, clamps, sutures, clips, etc.) such as a plurality of anchors 32. Anchor deployment manipulator 61 is advanced into the lumen of cannula 26 and from within the lumen, anchors are deployed through the wall of the cannula and into the heart tissue, thereby anchoring the cannula around a portion of the valve annulus. For some applications, the annuloplasty structure or annuloplasty ring structure 222 is implemented using the techniques described in U.S. Application No. 12 / 437,103 filed May 7, 2009 (issued as US 8,715,342) and / or U.S. Application No. 12 / 689,635 filed January 19, 2010 (issued as US 8,545,553), both of which are assigned to the assignee of the present application and are incorporated herein by reference.

[0350] like Figure 3A As shown, the procedure may begin by advancing a semi-rigid guidewire 202 into the patient's right atrium 220. The procedure may be performed with the aid of imaging, such as fluoroscopy, transesophageal echo, and / or echocardiography.

[0351] like Figure 3B As shown, the guidewire 202 provides guidance for the outer catheter 12 to be subsequently advanced along it and into the right atrium. Once the distal portion of the catheter 12 enters the right atrium, the guidewire 202 is retracted from the patient. The catheter 12 may include a 14-24F sheath, although any size may be selected to suit a given patient. The catheter 12 is advanced through the vascular system into the right atrium using an appropriate source point determined for a given patient. For example:

[0352] The catheter 12 may be introduced into the femoral vein of the patient, passed through the inferior vena cava 223, entered the right atrium 220, and then passed through the septum (e.g., through the fossa ovalis) into the left atrium 224;

[0353] The catheter 12 may be introduced into the basilic vein, passed through the subclavian vein to the superior vena cava, into the right atrium 220, and then transseptally (eg, through the fossa ovalis) into the left atrium 224; or

[0354] • The catheter 12 may be introduced into the external jugular vein, passed through the subclavian vein to the superior vena cava, into the right atrium 220, and then transseptally (eg, through the fossa ovalis) into the left atrium 224.

[0355] For some applications, catheter 12 is advanced through the patient's inferior vena cava 223 (as shown) and into right atrium 220 using an appropriate origin point for a given patient.

[0356] The catheter 12 can be advanced distally until the sheath reaches the atrial septum and the guidewire 202 is withdrawn, as shown in FIG. Figure 3C shown.

[0357] like Figure 3D As shown, a resilient needle 206 and a dilator (not shown) are advanced through the catheter 12 and into the heart. In order to advance the catheter 12 into the left atrium 224 through the septum, the dilator is advanced to the septum, and the needle 206 is pushed from within the dilator, and allowed to pierce the septum to create an opening that facilitates the passage of the dilator, and subsequently facilitates the passage of the catheter 12 and entry into the left atrium 224. The dilator passes through the hole in the septum created by the needle. The dilator can be shaped to define a hollow shaft for passing along the needle 206, and the hollow shaft is shaped to define a tapered distal end. The tapered distal end is first advanced through the hole formed by the needle 206. When the gradually increasing diameter of the distal end of the dilator is pushed through the hole in the septum, the hole is enlarged. For some applications, the distal end 102 of the catheter 12 is tapered to facilitate the passage of the distal portion of the catheter 12 through the opening in the septum.

[0358] After the catheter 12 is advanced through the septum into the left atrium, the dilator and needle 206 may be withdrawn from the catheter 12, as shown in FIG. Figure 3E As shown. Once the distal portion of the catheter 12 is positioned within the atrium 224, the maneuverable distal end portion of the catheter 12 (e.g., the curved portion 1203 of the catheter 12) can be manipulated in a first plane parallel to the plane of the annulus of the mitral valve 230. This manipulation moves the distal end portion of the catheter 12 in a direction from the atrial septum toward the surrounding atrial wall, as indicated by the arrow in the atrium 224. As described above, manipulation of the distal portion of the catheter 12 can be performed via the manipulation knob 210 of the handle 22 in the handle portion 101 ( Figure 1 and Figure 2 ).

[0359] like Figure 3F As shown, an annuloplasty structure or annuloplasty ring structure 222 (not shown for clarity with anchor deployment manipulator 61 therein) is advanced through guide catheter 14, which in turn is advanced through catheter 12 into left atrium 224. Figure 3FAs shown, the exposed distal end portion 114 of the catheter 14 (e.g., the curved portion 1403) extends beyond the distal end 102 of the catheter 12. The exposed distal end portion 114 is then (1) manipulated toward the annulus of the valve 230 along a plane perpendicular to the manipulation plane of the catheter 12 and perpendicular to the valve 230, and (2) bent toward the valve 230 via the curved portion 1403. As described above, manipulation of the distal portion of the catheter 14 is performed via the manipulation knob 214 of the handle 24 in the handle portion 101 ( Figure 1 and Figure 2 ).

[0360] like Figure 3G As shown, the distal end 251 of the sleeve 26 is positioned near the left fibrous trigone 242 of the annulus 240 of the mitral valve 230 (note that for clarity of illustration, the distal end 251 of the sleeve 26 is schematically shown in a cross-sectional view of the heart, although the left trigone 242 is not actually located in the cross-sectional plane shown, but is outside the page closer to the viewer). Alternatively, the distal end of the sleeve 26 is positioned near the right fibrous trigone 244 of the mitral valve (configuration not shown). Further alternatively, the distal end of the sleeve is not positioned near any of the trigone, but is positioned elsewhere near the mitral valve, such as near the anterior commissure or the posterior commissure. Once positioned at the desired site near the selected trigone, the deployment manipulator 61 deploys the first anchor 32 through the wall of the cannula 26 (by penetrating the wall of the cannula in a direction parallel to the central longitudinal axis of the deployment manipulator 61 or anchor driver 36, through the distal end of the channel 18, and / or penetrating the wall of the cannula in a direction parallel to the central longitudinal axis of the tissue engaging element 60 of the anchor 32) into the heart tissue near the trigone. After the anchor 32 is deployed in the heart tissue, the deployment element 38 is separated from the anchor 32 by moving the rod 130 proximally.

[0361] The anchor 32 can be deployed from the distal end of the manipulator 61, while the distal end is positioned so that the central longitudinal axis passing through the distal end of the manipulator 61 forms an angle of about 20 to 90 degrees, for example, 45 to 90 degrees, such as about 75 to 90 degrees, such as about 90 degrees, with the surface of the heart tissue. The anchor 32 can be deployed from the distal end of the manipulator 61 into the heart tissue in a direction parallel to the central longitudinal axis passing through the distal end of the manipulator 61. This angle can be provided and / or maintained by the channel 18 being more rigid than the sleeve 26. The distal end 17 ( Figure 2) can be close to the surface of the heart tissue (and the wall of the cannula 26 disposed against the surface of the heart tissue) such that each anchor 32 barely protrudes from the channel 18 prior to penetrating the cannula and tissue. For example, the distal end 17 of the channel 18 can be placed (e.g., pushed) against the wall of the cannula, thereby clamping the cannula to the heart tissue.

[0362] For some applications, such placement of the distal end 17 of the channel 18 against the heart tissue (via the wall of the cannula) stabilizes the distal end during deployment and anchoring of each anchor 32, and thereby facilitates anchoring. For some applications, pushing the distal end 17 against the heart tissue (via the wall of the cannula) temporarily deforms the heart tissue at the contact site. Such deformation can facilitate the use of imaging techniques to identify the contact site (e.g., by identifying deformations in the boundary between heart tissue and blood), and thereby can facilitate proper positioning of the anchor.

[0363] For some applications, anchor 32 may be deployed from a side portion of manipulator 61 .

[0364] Reference now Figure 3G and Figure 2 . After deployment of the first anchor, the distal portion of the sleeve 26 can be separated from a portion of the implant separation channel 18. To separate the portion of the sleeve 26 from the outer surface of the channel 18, (1) the channel 18 can be pulled proximally while (2) the reference force tube 19 is held in place in a manner such that the distal end of the tube 19 provides a reference force to the sleeve 26 to facilitate the release of the continuous portion of the sleeve 26 from the retraction around the channel 18. To separate the sleeve 26 from the outer surface of the channel 18, (1) the channel 18 can be pulled proximally while (2) the reference force tube 19 is held in place. An indicator on the handle 126 (such as the indicator 2120 described in PCT Patent Application PCT / IL2012 / 050451 to Sheps et al., published as WO / 2013 / 069019, which is incorporated herein by reference) provides an indication of how much of the channel 18 has been withdrawn from the cannula 26 (i.e., how much the delivery tool has been separated from the cannula 26 and how much the cannula has been advanced out of the channel 18 and against the tissue). The proximal end of the channel 18 is coupled to the knob 94 ( Figure 2 ), which adjusts the axial position of the channel 18 proximally and distally relative to the reference force tube 19 and the sleeve 26. Figure 3H As shown, the deployment manipulator 61 is repositioned along the annulus 240 to another site selected for deployment of the second anchor 32. Referring now to Figure 1 and Figure 3H This repositioning of the manipulator 61 is achieved by the following steps:

[0365] (1) manipulating the distal end portion of the catheter 12 (e.g., by the manipulation knob 210 of the handle 22) to a desired spatial orientation in a first plane parallel to the annulus 240 of the valve 230 and in a manner that bends the curved portion 1203 of the catheter 12,

[0366] (2) manipulating a distal end portion of a portion of the catheter 14 (e.g., by means of a manipulation knob 214 of the handle 24) to a desired spatial orientation in a second plane perpendicular to the annulus 240 of the valve 230 and in a manner that bends the curved portion 1405 (specifically the curved portion 1403) of the catheter 14,

[0367] (3) by axially moving the catheter 14 relative to the catheter 12 via the knob 216,

[0368] (4) moving both catheters 12 and 14 by axially moving the support supporting the handles 22 and 24,

[0369] (5) axially moving the tube 19 and sleeve 26 by sliding the bracket 93 along the track 90 via the knob 95, and / or

[0370] (6) The channel 18 is moved relative to the tube 19 by actuating the knob 94 .

[0371] Typically, the first anchor is deployed most distally in the cannula (typically at or within a few millimeters of the distal tip of the cannula), and each subsequent anchor is deployed more proximally, such that the cannula is gradually separated from the channel 18 of the deployment manipulator 61 in the distal direction during the anchoring procedure (i.e., the channel 18 is withdrawn from the cannula 26 and the handle 126 is moved distally to retract the tool, thereby preparing the successive proximal portions of the cannula 26 for implantation of subsequent anchors). The first anchor 32 that has been deployed holds the anchoring 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 heart tissue, such as Figure 3H The deployment manipulator 61 deploys the second anchor through the wall of the cannula 26 into the cardiac tissue at the second location. Depending on the tension applied between the first and second anchoring locations, the portion of the cannula 26 therebetween may maintain a tubular shape, or may become flattened, which may help reduce any interference of the ring with blood flow.

[0372] like Fig. 3IAs shown, the deployment manipulator 61 can be repositioned along the valve annulus to another site at which a corresponding anchor point is deployed until the final anchor point is deployed near the right trigone 244 (or the left trigone 242 if anchoring begins in the right trigone). Optionally, the final anchor point is not deployed near the trigone, but is deployed elsewhere near the mitral valve, such as near the anterior commissure or the posterior commissure. The system 10 is then removed, leaving behind the implant structure 222 and the contraction member 226. As described below, the contraction member receiving tool is then passed through the contraction member 226 and advanced along it toward the structure 222, and is used to contract the structure 222 ( Fig. 3I 226, but (i) the advancement of the contraction member receiving tool on the contraction member 226 is reference 4A to 5D mutatis mutandis, and (ii) applying tension to member 226 is described with reference to FIG. 6A to FIG. 6B described below).

[0373] Once the desired level of adjustment of structure 222 is achieved (e.g., by monitoring the degree of regurgitation of the valve under echocardiography and / or fluoroscopic guidance), the contraction member containment tool (1) locks contraction member 226 so as to maintain a degree of tension in member 226, thereby maintaining structure 222 in a contracted state, and (2) cuts off any excess portion of contraction member 226, which is then removed from the heart. For some applications, the distal portion of guide member 86 can remain within the patient's heart, and the proximal end can be accessible outside the body, for example using a port. For such applications, adjustment mechanism 40 can be accessed at a later stage after initial implantation and adjustment of ring structure 222.

[0374] For some applications, a reapproximation wire 288 may be provided that is coupled to a proximal portion of the implant (eg, a portion of the last implant to be deployed), such as to the last anchor 32 (eg, Fig. 3IThe wire 288 is positioned approximately 100 mm / s and approximately 100 mm / s in diameter and approximately 200 mm / s in diameter. The wire 288 is positioned approximately 100 mm / s and approximately 200 mm / s in diameter and approximately 200 mm / s in diameter. The wire 288 is positioned approximately 100 mm / s and approximately 200 mm / s in diameter and approximately 200 mm / s in diameter. The wire 288 is positioned approximately 100 mm / s and approximately 200 mm / s in diameter and approximately 200 mm / s in diameter. The wire 288 is positioned approximately 100 mm / s and approximately 200 mm / s in diameter and approximately 200 mm / s in diameter. The wire 288 is positioned approximately 100 mm / s and approximately 200 mm / s in diameter and approximately 200 mm / s in diameter.

[0375] As shown, the sleeve 26 of the ring structure 222 includes a plurality of radiopaque markers 25 positioned at respective longitudinal locations along the sleeve to indicate the target area designated for the anchors. The markers can provide an indication in a radiographic image (such as a fluoroscopic image) of how many sleeves 26 are deployed at any given point during the implantation procedure so that the desired distance between the anchors 32 can be set along the sleeve 26.

[0376] For some applications, and such Fig. 3I As shown, the anchor 32 is deployed at a longitudinal location of the cannula 26 where the radiopaque marker 25 is provided (e.g., the anchor is driven through the radiopaque ink of the radiopaque marker). Alternatively, the anchor 32 can be deployed at a longitudinal location of the cannula 26 between the markers 25. For example, when the cannula 26 is dispensed from the channel 18 (i.e., when the cannula 26 is advanced relative to the channel 18 and / or the channel 18 is withdrawn from the cannula 26), the appearance of the marker 25 at the distal end of the channel 18 (e.g., the marker 25 becomes aligned with the marker 1018 of the channel 18) can indicate that the correct length of the cannula 26 has been dispensed. Subsequently, limited movement of the channel relative to the cannula can occur. For example, when channel 18 is placed against the annulus, the channel can tension the portion of the sleeve 26 between the previously deployed anchor and the distal end of the channel so that when the anchor is deployed, it passes through the sleeve slightly proximal to the marking 25 (e.g., 1 mm to 2 mm proximal to the marking).

[0377] Alternatively, the annuloplasty structure 222 is implanted mutatis mutandis through a right thoracotomy or a left thoracotomy.

[0378] For some applications, after implantation of the cannula 26 along the annulus, an excess portion of the cannula 26 may exist at the proximal portion of the cannula. In such applications, after removing the manipulator 61, a cutting tool (not shown) may be advanced within the channel 18 and into the lumen of the excess portion of the cannula 26 (e.g., from within the cannula 26) to cut the cannula proximal to the most proximal deployed anchor 32.

[0379] Reference now FIG. 4A to FIG. 4B , which is a schematic diagram of an exemplary system 10 including an exemplary contraction member receiving tool 300, which is configured to contract the contraction member 226 and cut off any excess portion of the contraction 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 the respective proximal ends of the tubes 330 and 340. The secondary tube 340 has a secondary tube lumen configured to allow the contraction member 226 to pass therethrough. The tool 300 defines a longitudinal axis 301.

[0380] For some applications, sheath 310 is shaped to define a lumen in the wall of sheath 310. For such applications, tool 300 does not include secondary tube 340, but rather the lumen in the wall of sheath 310 serves as secondary tube 340 and the primary lumen defined by the wall of sheath 310 serves as primary tube 330.

[0381] The sheath 310, the main tube 330 and the secondary tube 340 can be flexible so that the sheath 310, the main tube 330 and the secondary tube 340 are configured to pass through the vascular system of the patient during a transvascular, transcatheter procedure. However, similar features can be used for surgical procedures. For some applications, the sheath 310, the main tube 330 and the secondary tube 340 include silicone. For some applications, the sheath 310, the main tube 330 and the secondary tube 340 include polyurethane.

[0382] The tool 300 may include a contraction member snare 350 including a distal snare portion 352 and an elongated flexible body portion 354 coupled 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 is sized to pass through the secondary tube lumen of the secondary tube 340 so as to pull the contraction member 226 through the length of the secondary tube 340.

[0383] The distal snare portion 352 can define a loop portion, as shown. For some applications, the distal snare portion 352 is shaped to define a hook.

[0384] The tool 300 may include a distal end portion 333 having a distal tip 331 defining a distal end of the tool 300. The main tube 330 terminates at the distal end portion 333. The distal end portion 333 includes a housing 332 that is shaped to hold and removably couple a contraction member fastener 360. The contraction member fastener 360 includes a clamping structure that may be biased toward assuming a closed state or position, and in the closed state / position, the clamping structure may be configured to clamp on a contraction member 226 (not shown) passing therethrough. The clamping structure may also be configured so that it can be deflected to an open state in which the contraction member 226 (not shown) can move therethrough.

[0385] The tool 300 may include a fastener-ejector 335 movable within a distal end portion 333 of the retraction member receiving tool 300. Movement of the fastener-ejector 335 transitions the retraction member fastener 360 (or its clamping structure) from its open state to its closed state to clamp onto the retraction member 226 passing therethrough, as will be described below. The tool 300 includes a stopper 362 that is removably coupled to the retraction member fastener 360 and is configured to hold the retraction member fastener 360 in the open state, as described below. Figure 4A The stopper 362 includes one or more (e.g., two) prongs 337 that hold the fastener 360 in an open state. The ejector 335 is coupled to the stopper 362 and moves the stopper 362 removably coupled to the fastener 360 so as to convert the fastener 360 from the open state to the closed state, as described below.

[0386] Figure 4B The handle portion 320 of the tool 300 is shown with the housing removed to view the interior of the handle portion 320. The handle portion 320 includes a contraction member receiving device 322 that is configured to receive a continuous portion (not shown) of the contraction member 226, as described below. The contraction member receiving device 322 can be actuated to increase the tension of the contraction member, as described below. The tension of the contraction member 226 is measured by a tension gauge 324 of the handle portion 320.

[0387] The contraction member receiving device 322 can optionally include a wheel that can have two opposing wedge-shaped portions 325 that together define a groove 326 configured to couple the contraction member 226 to the wheel of the device 322. The wedge-shaped portions 325 can be shaped to receive any portion of the contraction member 226, for example, the proximal end of the member 226 and / or the middle portion of the member 226. For some applications, the opposing wedge-shaped portions 325 are configured to grip the contraction member 226. As shown, the wheel of the device 322 can have a digital indicator to indicate the number of revolutions of the wheel.

[0388] As shown, the handle portion 320 is coupled to respective proximal portions of the primary tube 330 and the secondary tube 340 .

[0389] The handle portion 320 may be shaped to define a lumen 328 for the snare 350 to pass through the lumen of the secondary 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, but rather the snare 350 passes through the groove 326. As described below, pulling the snare 350 pulls the contraction member 226 coupled thereto, so that the contraction member 226 is pulled through the secondary 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 a portion of the member 226 near the proximal end) is pulled through the tube 340 and through the lumen 328, the contraction member 226 is coupled to the contraction member receiving device 322 by being fed into the groove 326. The contraction member receiving device 322 is then actuated to apply tension to the contraction member 226, thereby applying tension to the annuloplasty 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 rolled within the groove 326 of the device 322.

[0390] FIG. 5A to FIG. 5D 2 is a schematic diagram of an exemplary contraction member receiving tool 300 that can be used to receive the contraction member 226. At this stage, the annuloplasty structure or annuloplasty ring structure 222 has been implanted along the annulus 240, as described above with reference to FIG. 3A to FIG. 3I Once the structure 222 has been implanted along the annulus, the retraction member 226 is extended away from the structure 222 and through the patient's vasculature such that the proximal end portion of the member 226 is disposed outside the patient's body.

[0391] The contraction member 226 can exit the sheath 26 of the structure 222 at any suitable location along the structure 222. For example, the contraction member 226 can exit the sheath 26 of the structure 222 at a portion of the structure 222 adjacent to the left trigone of the valve, as shown. For some applications, the contraction member 226 exits the sheath 26 of the structure 222 at a portion of the structure 222 adjacent to the right trigone of the valve. For some applications, the contraction member 226 exits the sheath 26 of the structure 222 at a middle portion of the structure 222.

[0392] As shown, the structure 222 includes a sleeve 26 defining a main body portion of the structure 222. The contraction member 226 has a first portion 420 extending along the longitudinal length of the main body portion of the annuloplasty structure 222. The first portion 420 can extend along the longitudinal length of the structure 222 when the structure 222 is in a linear state and in a bent state, such as Figure 5A The retraction member 226 also defines a second portion 422 that extends away from the main body portion of the annuloplasty structure 222 .

[0393] exist Figure 5A In the embodiment of the present invention, a user (e.g., an operating physician, etc.) can hold the distal end of the tool 300 with one hand and hold 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.

[0394] Figure 5B The tool 300 is shown in a state in which the distal snare portion 352 is encircled by the contraction member 226. For some applications, the distal snare portion 352 is shaped to increase the coupling between the snare 350 and the contraction member 226. For example, for some applications, the distal snare portion 352 is corrugated to increase the friction between the snare portion 352 and the contraction member 226. For some applications, the distal snare portion 352 may include a coiled portion to increase the friction between the snare portion 352 and the contraction member 226. For some applications, the snare 350 includes a metal wire. For some applications, the snare 350 includes a metal wire including stainless steel. The snare 350 (including the distal snare portion 352) can have a variety of sizes, for example, a diameter of 0.15 mm to 0.5 mm or 0.15 mm to 0.35 mm.

[0395] Reference now Figure 4A and Figure 5B .like Figure 4A As shown in section AA of FIG. 3 , the retraction member snare 350 passes through the alignment ports 339 and 341 in the distal end portion 333 of the tool 300 .

[0396] The snare 350 can be pulled proximally, for example, by a user or physician gripping the proximal exposed end 351 of the snare 350 proximally away from the tool 300. Figure 5C As shown, the snare 350 is pulled proximally, pulling the distal snare portion 352 and the contraction member 226 looped therethrough through the distal tip 331 of the tool 300, through the fasteners disposed within 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 then through the lumen of the secondary tube 340.

[0397] The snare 350 is pulled until the distal snare portion 352 enters the lumen of the secondary tube 340. As a result, the looped portion of the distal snare portion 352 is compressed and collapsed around the contraction member 226 passing therethrough so that the elongated flexible body portion 354 ( Figure 5B 340) is pulled through the lumen of the secondary tube 340 to maintain the connection between the snare portion 352 and the contraction member 226. 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 that is caught 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 caused by the relatively small diameter of the secondary tube 340 of 0.5 mm to 1.0 mm.

[0398] exist Figure 5D 326 . In some embodiments, the snare 350 is pulled completely through the secondary tube 340, through the lumen 328 of the handle portion 320, and over the groove 326 of the constriction member containment device 322 so as to pull the constriction member 226 along the path. All the while, the sheath 310 of the tool 300 is advanced through the vasculature and toward the annuloplasty structure 222 implanted along the annulus 240 of the valve. Once the distal snare portion 352 and the portion of the constriction member 226 coupled thereto exit the lumen 328 of the handle portion 320, the portion of the constriction member 226 is coupled to the constriction member containment device 322 by being positioned within the groove 326. For some applications, a proximal end portion of the constriction member 226 is fed into the groove 326. For some applications, an intermediate portion of the constriction member 226 (e.g., a portion near the proximal end of the constriction member 226) is fed into the groove 326. Then, the retracting member 226 is tightened by actuating (eg, rotating) the retracting member receiving device 322 so that a continuous portion of the retracting member 226 is wound within the retracting member receiving device 322 and the retracting member receiving device 322 receives the continuous portion.

[0399] Once the snare 350 has been pulled through the tool 300, the snare 350 may be discarded.

[0400] Reference now FIG. 6A to FIG. 6B, which is a schematic diagram of an exemplary tool 300 for pulling a contraction member 226 so as to contract the contraction member 226 and thereby contract the annuloplasty structure or annuloplasty ring structure 222 coupled thereto. The contraction member receiving device 322 is rotated so as to receive a continuous portion of the contraction member 226.

[0401] like Fig. 6A As shown, before rotating the contraction member receiving device 322, the tension gauge 324 of the handle portion 320 indicates that the tension of the contraction member 226 is zero or close to zero. Similarly, the sleeve 26 of the annuloplasty structure 222 coupled to the annulus 240 is in a relaxed, non-tensioned state. At this point, the tool 300 has been sufficiently advanced through the patient's vasculature so that the distal tip 331 is close to the structure 222 disposed along the annulus, while the proximal portion of the contraction member 226 is disposed outside the patient's body.

[0402] exist Figure 6B , the contraction member receiving device 322 is rotated to contract and apply tension to the contraction member 226. The tension gauge 324 of the handle portion 320 indicates that the tension of the contraction member 226 is between 4 and 5. Similarly, the sleeve 26 of the annuloplasty structure 222 coupled to the annulus 240 is in a tensioned, contracted state. Figure 6B As shown, the retraction member 226 is in tension relative to the tool 300 .

[0403] Reference now 7A to 7E , which is a schematic illustration of an exemplary tool 300 for locking and securing the annuloplasty structure 222 in its contracted state and subsequently severing excess portions of the contraction member 226.

[0404] Fig. 7A An annuloplasty structure or annuloplasty ring structure 222 is shown in a non-contracted state. The distal tip 331 of the tool 300 can be proximate to the structure 222. The contraction member 226 can be threaded along the cannula 26 and out of a portion of the cannula 26 of the structure 222. As described above, the contraction member 226 can be threaded through the tool 300 in a manner where 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 prong 337 of the stopper 362, through the alignment ports 339 and 341 in the distal end portion 333 of the tool 300, and through the secondary tube 340.

[0405] like Figure 7B As shown, once distal tip 331 of tool 300 contacts cannula 26 of structure 222, tool 300 may be used to contract structure 222 by pulling contraction member 226 through tool 300. During contraction of structure 222, fastener 360 is not deployed.

[0406] exist Figure 7C In the embodiment of the present invention, the contraction member 226 is tensioned and the annuloplasty structure 222 is contracted and placed in a tensioned, contracted state. The distal end portion 333 of the tool 300 is then used to eject and deploy the fastener 360 from within the tool 300 to lock the structure 222 in the contracted state.

[0407] Reference now Figure 6B and Figure 7C Once the distal tip 331 contacts the cannula 26, the trigger 321 at the handle portion 320 of the tool 300 is partially pulled ( Figure 6B 333 of the contraction member receiving tool 300. As described above, the fastener-ejector 335 is movable within the distal end portion 333 of the contraction member receiving tool 300. The movement of the fastener-ejector 335 converts the contraction member fastener 360 from its open state to its closed state to clamp onto the contraction member 226 passing therethrough. The fastener-ejector 335 is coupled to the prong 337 of the stopper 362 in such a manner that the stopper 362 separates from the contraction member fastener 360 as the prong 337 moves proximally away from the contraction member fastener 360 as the ejector 335 moves proximally within the portion 333. Once the contraction member fastener 360 is no longer held in the open state by the stopper 362, the fastener 360 closes as it would otherwise and clamps around the contraction member 226 passing therethrough.

[0408] 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 the 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. Figure 7B As shown, the fastener 360 has been ejected and deployed from within the housing 332 of the ejector 335 .

[0409] exist Fig.7D In the embodiment of the present invention, the fastener-ejector 335 can be further moved proximally in response to further pulling of the trigger 321 to cut off the excess portion of the retraction member 226. The tool 300 can be formed to define a cutting facilitating edge 370 in the distal end portion 333 of the tool 300. For some applications, the cutting facilitating edge 370 defines a sharp edge. When the retraction member 226 passes through the alignment ports 339 and 341 in the distal end portion 333 of the tool 300, as shown in FIG. FIG. 7A to FIG. 7CAs shown, retraction member 226 is proximate to cutting facilitating edge 370. Proximal movement of fastener-ejector 335 causes cutting facilitating edge 372 of ejector 335 to abut cutting facilitating edge 370 of tool 300, thereby clamping a portion of retraction member 226 between edges 370 and 372 to sever and cut retraction member 226 extending through ports 339 and 341. For some applications, cutting facilitating edge 372 defines a sharp edge. Fig.7D It is shown that once the cutting facilitating edge 372 of the ejector 335 has abutted the cutting facilitating edge 370 of the tool 300, the retraction member 226 is severed.

[0410] like Fig. 7E As shown, once the retraction member 226 is severed, the tool 300 is withdrawn proximally, thereby driving the excess portion of the retraction member 226 together therewith.

[0411] Reference now FIG. 8A to FIG. 8D , which is a schematic diagram of an example of a system 510 for constricting a patient's annulus 240 using an annuloplasty structure 522 (e.g., an annuloplasty ring structure, a closed annuloplasty structure, a closed annuloplasty ring structure, an open annuloplasty structure, a partial annuloplasty ring structure, etc.), which can include a housing 530. The housing 530 can house a constriction member fastener 360. The annuloplasty structure 522 can be similar to the above-referenced system 510 except for the differences described below. Figures 1 to 7E The depicted annuloplasty structures 222 are identical or substantially similar, and like reference numerals refer to like components.

[0412] The annuloplasty structure or annuloplasty ring structure 522 may include a sleeve 26 that may define a main body portion of the structure 522. The structure 522 includes a contraction member 226 having a first portion 526 extending along a longitudinal length of the main body portion of the annuloplasty 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 FIG. Fig. 8A The retraction member 226 also defines a second portion 524 that extends away from the main body portion of the annuloplasty structure 522 .

[0413] The contraction member 226 can extend through the housing 530 and through a stopper 570 (e.g., a retainer) disposed within the opening of the contraction member fastener 360. By way of illustration and not limitation, the stopper 570 is shown as being cylindrical. The outer surface of the stopper 570 retains the fastener 360 in an open state. The stopper 570 is shaped to define a threaded portion 572 that enables a contraction member receiving tool to be coupled thereto, as described below.

[0414] Use the above reference Figures 1 to 3I The system, as mentioned above FIG. 3A to FIG. 3I The annuloplasty structure or annuloplasty ring structure 522 is implanted.

[0415] The housing 530 can be coupled to the sleeve 26 of the structure 522 at any suitable position along the structure 522. For example, as shown, the housing 530 can be coupled to the sleeve 26 of the structure 522 at a portion of the left fiber trigone of the structure 522 adjacent to the valve. For some applications, the housing 530 can be coupled to the sleeve 26 of the structure 522 at a portion of the right fiber trigone of the structure 522 adjacent to the valve. For some applications, the housing 530 can be coupled to the sleeve 26 of the structure 522 at a middle portion of the structure 522. As shown, the housing 530 can be coupled to the side surface of the sleeve 26. In such applications, the housing 530 does not block the lumen of the sleeve 26 of the structure 522.

[0416] Figure 8B The retraction member receiving tool 600 is shown with the retraction member 226 threaded through the tool. The retraction member 226 may be used as described above with reference to 4A to 5D The snare described with respect to snare 350 is captured by tool 600. Tool 600 may be advanced along contraction member 226 toward housing 530 of structure 522 in a manner similar to that of tool 300 as advanced along contraction member 226, as described above with reference to 4A to 5D described.

[0417] Tool 600 may include a distal tip 631 and a substantially similar FIG. 4A to FIG. 7E The distal end portion 633 of the distal end portion 533 of the tool 300 is similar to that of the distal end portion 533 of the tool 300, and like reference numerals denote like components. The distal end portion 633 of the tool 600 is different from that of the distal end portion 533 of the tool 300, as the annuloplasty structure 522 includes the contraction member fastener 360 and the stopper 570 removably coupled to the fastener 360. FIG. 4A to FIG. 7E The distal end portion 533 of the tool 300 , and the rest of the tool 600 corresponds to the rest of the tool 300 .

[0418] Once tool 600 is threaded along retraction member 226 , retraction member 226 extends from cannula 26 , through stopper 570 , through stopper-coupler 672 of tool 600 , through distal tip 631 , and then through alignment ports 339 and 341 of distal end portion 633 of tool 600 .

[0419] The stopper-coupler 672 of the tool 600 threads into and engages the threaded portion 572 of the stopper 570 , which is coupled to the retraction member fastener 360 disposed within the housing 530 of the structure 522 .

[0420] As mentioned above FIG. 6A to FIG. 6B As described above, the contraction member receiving device of tool 600 (not shown, but similar to the contraction member receiving device 322 of tool 300) can be used to contract the contraction member 226. Once the contraction member 226 is contracted and the structure 522 is contracted, as shown in FIG. Figure 8C As shown, the tool 600 removes the stopper 570 by pulling the stopper 570 proximally away from the fastener 360. Since the fastener 360 tends to close, in the absence of the stopper 570, the fastener 360 closes and clamps around the contraction member 226 passing through the fastener 360. In this way, the structure 522 is locked by the fastener 360, and the contracted state of the structure 522 is maintained.

[0421] Fig.8D The contraction member 226 is shown cut near the fastener 360, and the excess portion of the contraction member 226 is removed from the patient's body using the tool 600. The contraction member 226 is cut as described above with reference to 7A to 7E The above-described method is implemented mutatis mutandis.

[0422] Reference now 9A to 9D , which is used to FIG. 8A to FIG. 8D Schematic diagram of an exemplary contraction member receiving tool 600 for locking and securing the annuloplasty structure 522 in its contracted state and subsequently cutting off the excess portion of the contraction member 226.

[0423] Fig. 9A The annuloplasty structure 522 is shown in a partially contracted state. The contraction member 226 can be threaded along the cannula 26 and out of a portion of the cannula 26 of the structure 222. As described above, the contraction member 226 can be threaded through the tool 600 in a manner where the member 226 passes through the stopper-coupler 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 secondary tube 340.

[0424] exist Fig. 9B , the contraction member 226 is tensioned and the annuloplasty structure 522 is contracted and in a tensioned, contracted state. The distal end portion 633 of the tool 300 is brought into proximity with the annuloplasty structure 522 (e.g., the tip 631 contacts the housing 530 or is brought into proximity, as shown) to eject and deploy the fasteners 360 within the housing 530 to lock the structure 522 in the contracted state.

[0425] Once the distal end portion 633 is proximal to the cannula 26, a trigger (similar to Figure 6BThe trigger 321 of the illustrated tool 300 can be partially pulled to facilitate distal ejection and deployment of the contraction member fastener 360 within the housing 530 of the annuloplasty structure 522. The fastener-ejector 335 is movable within the distal end portion 633 of the contraction member receiving tool 600. Movement of the fastener-ejector 335 transitions the contraction member fastener 360 (e.g., its clamping structure) from its open state to its closed state to clamp onto the contraction member 226 passing therethrough. The fastener-ejector 335 is coupled to a stopper-coupler 672 of the tool 600 that is threaded into and engages a threaded portion 572 of the stopper 570 in such a manner that when the ejector 335 is moved proximally within the portion 633 of the tool 600, the stopper 570 is pulled away from and separated from the fastener 630. Once the retraction member fastener 360 is no longer held in the open state by the stop 570, the fastener 360 closes as it would otherwise and clamps around the retraction member 226 passing therethrough.

[0426] exist Fig. 9C 6, the fastener-ejector 335 can be further moved proximally (in response to further pulling of the trigger of the handle portion of the tool 600) to cut off the excess portion of the retraction member 226. The tool 600 can be formed to define a cutting facilitating edge 370 in the distal end portion 633 of the tool 600. For some applications, the cutting facilitating edge 370 defines a sharp edge. When the retraction member 226 passes through the alignment ports 339 and 341 in the distal end portion 633 of the tool 600, as shown in FIG. Fig. 9B As shown, retraction member 226 is proximate to cutting facilitating edge 370. Proximal movement of fastener-ejector 335 causes cutting facilitating edge 372 of ejector 335 to abut cutting facilitating edge 370 of tool 300, thereby clamping a portion of retraction member 226 between edges 370 and 372 to sever and cut retraction member 226 extending through ports 339 and 341. For some applications, cutting facilitating edge 372 defines a sharp edge. Fig. 9C It is shown that once the cutting facilitating edge 372 of the ejector 335 has abutted the cutting facilitating edge 370 of the tool 600, the retraction member 226 is severed.

[0427] like Fig.9D As shown, once the retraction member 226 is severed, the tool 600 is withdrawn proximally, thereby driving the excess portion of the retraction member 226 together therewith.

[0428] Reference now 8A to 9DThe system 510 provides an annuloplasty structure 522 (e.g., an annuloplasty ring structure, a closed annuloplasty structure, a closed annuloplasty ring structure, an open annuloplasty structure, a partial annuloplasty ring structure, etc.) wherein the housing 530 houses the retraction member fastener 360, rather than the fastener 360 being disposed external to the cannula 26. In this manner, the system 510 reduces the likelihood of embolism and / or clotting.

[0429] Reference now 4A to 9D The contraction member containment tools 300 and 600 may be used to (1) apply tension to the contraction member, (2) deploy a lock to secure the contraction member tension, and (3) subsequently cut and sever the contraction member of any annuloplasty structure (e.g., a full annuloplasty ring structure, a partial annuloplasty ring structure, etc.).

[0430] Reference again FIG. 8A to FIG. 8D and 9A to 9D It should be noted that although the tool 600 is described as being advanceable toward the housing 530 already coupled to the annuloplasty structure 522, the scope herein includes the tool 600 being coupled to the housing 530 from a site outside the patient's body and the cannula 26 being configured to deliver the housing 530 along the retraction member 226 to the structure 522 already implanted at the annulus. For such applications, the housing 530 is configured to be positionable against the main body portion of the structure 522.

[0431] Reference now FIG. 10A to FIG. 10B , which is a schematic diagram of an exemplary system 700 including an exemplary retraction member receiving tool 702 configured to retract the retraction member 226 and cut off any excess portion of the retraction member 226.

[0432] The retraction member receiving tool 702 may be similar to the one described above with reference to 4A to 9D The described contraction member containment tools 300 and 600 are the same or substantially similar and are used to (1) apply tension to a contraction member, (2) deploy a lock to ensure tension on the contraction member, and (3) subsequently cut and sever the contraction member of any annuloplasty structure, such as a complete (or closed) annuloplasty ring structure or a partial (or open) annuloplasty ring structure.

[0433] The exemplary contraction member receiving tool 702 can be used to receive the contraction member 226 of the annuloplasty structure 730. The annuloplasty structure 730 can be used in conjunction with the annuloplasty structure 730 described above. Figures 1 to 9DThe annuloplasty structures 222 and 522 described above are the same or substantially similar, and like reference numerals represent like components. At this stage, an annuloplasty structure 730 (e.g., annuloplasty ring structure, closed annuloplasty structure, closed annuloplasty ring structure, open annuloplasty structure, partial annuloplasty ring structure, etc.) has been implanted along the annulus, as described above with reference to FIG. 3A to FIG. 3I Once the structure 730 has been implanted along the annulus, the retraction member 226 is extended away from the structure 730 and through the patient's vasculature such that the proximal end portion of the member 226 is disposed outside the patient's body.

[0434] The annuloplasty structure 730 may be similar to that described above with reference to Figures 1 to 9D The depicted annuloplasty structures 222 and 522 are identical or substantially similar, and like reference numerals refer to like components.The annuloplasty structure 730 may be a full (or closed) or partial (or open) annuloplasty structure.

[0435] As shown, the structure 730 includes a sleeve 26 defining a body portion of the structure 730. The contraction member 226 has a first portion 732 extending along the longitudinal length of the body portion of the annuloplasty structure 730. The contraction member 226 also defines a second portion 734 extending away from the body portion of the annuloplasty structure 730.

[0436] Although tool 702 is used to implant a complete (or closed) annuloplasty structure 730, as shown, the annuloplasty structure may be an annuloplasty ring structure and may include a partial (or open) annuloplasty structure.

[0437] For some applications, the annuloplasty structure 730 is implemented using techniques described in U.S. application Ser. No. 12 / 341,960, filed Dec. 22, 2008 (issued as U.S. Pat. No. 8,241,351), U.S. application Ser. No. 12 / 437,103, filed May 7, 2009 (issued as U.S. Pat. No. 8,715,342), and / or U.S. application Ser. No. 12 / 689,635, filed Jan. 19, 2010 (issued as U.S. Pat. No. 8,545,553), all of which are assigned to the assignee of the present application and are incorporated herein by reference.

[0438] The tool 702 can be constructed in a variety of ways. In some applications, the tool 702 includes an elongated sheath 310. In some applications, the sheath 310 encloses the main tube 330 and the secondary tube 340 disposed side by side with the main tube 330. For such applications, the sheath 310 is shaped to define the secondary tube 340. The secondary tube 340 is shaped to define a longitudinal slit 740. The slit 740 facilitates easy connection and engagement of the contraction member 226 within the lumen of the tube 340. The slit 740 also makes it easy to release the contraction member 226 from the lumen of the tube 340. For some applications, the slit 740 facilitates the release of the contraction member 226 from the lumen of the tube 340 as described above. FIG. 4A to FIG. 4B For some applications, the distal-most portion of slit 740 is at a longitudinal position along tube 340 proximal to the distal-most end of tube 340, e.g., a portion of tube 340 configured to be placed proximal to a ventricle of a patient's heart, such that blood is prevented from leaking from within the heart through slit 740.

[0439] Tool 702 is used to deploy one or more (eg, two as shown) contraction member fasteners 360a and 360b. Fasteners 360a and 360b are similar to those described above with reference to 4A to 9D The fasteners 360 described are similar or identical. Using two fasteners 360a and 360b can provide redundancy and a more secure fastening of the perimeter of the structure 730 after it is collapsed. The fasteners 360a and 360b can be coaxially disposed around a portion of the collapse member 226.

[0440] For some applications, the contraction member fasteners 360a and 360b are deployed using a push tube (not shown). The push tube includes a semi-rigid material for deployment by pushing the fasteners 360a and 360b. The fasteners 360a and 360b can be coaxially disposed around a portion of the contraction member 226 and distal to the distal end of the push tube. For some applications, the fasteners 360a and 360b are removably disposed around a portion of the push tube.

[0441] After deployment of fasteners 360a and 360b, tool 702 is used to cut off any excess portion of retraction member 226, as described below with reference to 4A to 9D The tools 300 and 600 are described above.

[0442] For some applications, outer sheath 710 is not used, and tool 702 is coupled to an annuloplasty structure using male and female couplings, as described below with reference to FIGS. 12 , 13 , and 15 .

[0443] Reference now FIG. 11A to FIG. 11C, which is a schematic diagram of an exemplary system 800 according to some applications, the system including an exemplary contraction member receiving tool 810, which is used to lock and secure the annuloplasty structure 222 in its contracted state and then cut off the excess portion of the contraction member 226.

[0444] The retraction member receiving tool 810 may be similar to the one described above with reference to 4A to 9D The described contraction member containment tools 300 and 600 are the same or substantially similar and are used to (1) apply tension to a contraction member, (2) deploy a lock to ensure tension in the contraction member, and (3) subsequently cut and sever the contraction member of any annuloplasty structure, such as a complete (or closed) annuloplasty ring structure, a partial (or open) annuloplasty structure, etc.

[0445] Fig.11A An annuloplasty structure or annuloplasty ring structure 222 is shown in a non-contracted state. The distal tip 331 of the tool 810 can be proximal to the structure 222. The contraction member 226 can be threaded along the cannula 26 and out of a portion of the cannula 26 of the structure 222. As described above, the contraction member 226 can be threaded through the tool 810 in a manner where 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 prong 337 of the stopper 362, through the alignment ports 339 and 341 in the distal end portion 333 of the tool 810, and through the secondary tube 340. For some applications, the distal end portion of the tool 810 is similar to that described above with reference to FIG. FIG. 10A to FIG. 10B 12 , 13 , and 15 . For such applications, tool 920 includes a male coupling 925, and annuloplasty structure 222 includes a housing 930 shaped to define a female coupling 927.

[0446] The tool 810 includes a proximal handle portion 820. The handle portion 820 includes a proximal contraction facilitating knob 830. The knob 830 is fixedly coupled to a proximal end 832 of the contraction member 226. Fig.11A Rotation of the contraction facilitating knob 830 is shown to move the knob 830 proximally. When the knob 830 is pulled proximally, the contraction member 226 is pulled proximally. In response, the annuloplasty structure 222 contracts. The tool 810 includes a gauge 834 that indicates the level of contraction of the ring in response to the number of rotations of the knob 830.

[0447] like Fig. 11BAs shown, once the distal tip 331 of the tool 810 contacts the sleeve 26 of the structure 222 (or, for some applications, the housing of the annuloplasty structure, as described above with reference to FIGS. 12 , 13 , and 15 ), the tool 810 can be used to pull the contraction member 226 in response to rotation of the knob 830 by the tool 810, thereby contracting the structure 222, as described above with reference to Fig.11A During contraction of structure 222, fasteners 360 are not deployed.

[0448] exist Fig. 11C In the embodiment of the present invention, the contraction member 226 is tensioned and the annuloplasty structure 222 is contracted and placed in a tensioned, contracted state. The distal end portion 333 of the tool 810 is then used to eject and deploy the fastener 360 from within the tool 810 to lock the structure 222 in the contracted state.

[0449] In some applications, once the distal tip 331 contacts the cannula 26, the trigger knob 840 at the handle portion 820 of the tool 810 is partially pulled to facilitate ejection and deployment of the contraction member fastener 360 from the housing 332 of the distal end portion 333. The fastener-ejector 335 is movable within the distal end portion 333 of the contraction 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. The proximal movement of the trigger knob 840 pulls the actuation wire 842 proximally, which in turn maximally tensions the fastener-ejector 335. The movement of the fastener-ejector 335 proximally converts the contraction member fastener 360 from its open state to its closed state to clamp onto the contraction member 226 passing therethrough. The fastener-ejector 335 is coupled to the prongs 337 of the stopper 362 in such a manner that, as the ejector 335 moves proximally within the portion 333, the stopper 362 separates from the retraction member fastener 360 as the prongs 337 move proximally away from the retraction member fastener 360. Once the retraction member fastener 360 is no longer held in the open state by the stopper 362, the fastener 360 closes as it would otherwise and clamps around the retraction member 226 passing therethrough.

[0450] The actuation wire 842 is disposed within an inner sheath 841 that extends along the length of the elongated sheath 310. For such applications, FIG. 11A to FIG. 11C As shown, the elongate sheath 310 comprises a multi-lumen sheath defining (1) a first lumen for accommodating an inner sheath 841 through which an actuation wire 842 passes, and (2) a second lumen for the constriction member 226 to pass therethrough.

[0451] like Fig. 11CAs shown, fastener 360 has been ejected and deployed from housing 332 of ejector 335. Subsequently, in response to further proximal pulling of trigger knob 840, fastener-ejector 335 moves further proximally to cut off the excess portion of retraction member 226. Similar to tools 300 and 600 described above, tool 810 is formed to define a cutting facilitating edge 370 in distal end portion 333 of tool 810. For some applications, cutting facilitating edge 370 defines a sharp edge. When retraction member 226 passes through alignment ports 339 and 341 in distal end portion 333 of tool 810, as shown in FIG. FIG. 11A to FIG. 11C As shown, the retraction member 226 is proximate to the cutting facilitating edge 370. The proximal movement of the fastener-ejector 335 causes the cutting facilitating edge 372 of the ejector 335 to abut against the cutting facilitating edge 370 of the tool 810, thereby clamping a portion of the retraction member 226 between the edges 370 and 372 to sever and cut the retraction member 226 extending through the ports 339 and 341. For some applications, the cutting facilitating edge 372 defines a sharp edge. Fig. 11C It is shown that once the cutting facilitating edge 372 of the ejector 335 has abutted the cutting facilitating edge 370 of the tool 300, the retraction member 226 is severed.

[0452] After severing the retraction member 226, the tool is removed from the patient's body by withdrawing the tool 810 proximally, leaving the excess portion of the retraction member 226 bonded thereto.

[0453] Reference now FIG. 11A to FIG. 11C For some applications, trigger knob 840 is coupled to a safety mechanism to prevent inadvertent deployment of fastener 360 .

[0454] Reference now FIG. 12A to FIG. 12C , which is a schematic diagram of an example of a system 900 including an exemplary annuloplasty structure 910 (e.g., an annuloplasty ring structure, a closed annuloplasty structure, a closed annuloplasty ring structure, an open annuloplasty structure, a partial annuloplasty ring structure, etc.) that includes a sleeve 26, a contraction member 226, and a lock 950. The implantable annuloplasty structure 910 includes a body portion 912. The contraction member 226 has a first portion 914 extending along a longitudinal length of the body portion 912 of the annuloplasty structure 910, and a second portion 916 extending away from the body portion 912 of the annuloplasty structure 910. The contraction member 226 is configured to adjust the circumference of the annuloplasty structure 910.

[0455] Except for the differences described below, the annuloplasty structure 910 may be similar to the annuloplasty structure 910 described above with reference to Figures 1 to 11CThe depicted annuloplasty structures 222, 522, and 730 are the same or substantially similar, and like reference numerals refer to like components.The annuloplasty structure 910 may be a full (or closed) or partial (or open) annuloplasty structure.

[0456] The body portion 912 of the structure 910 has a sidewall and is shaped to define a recess 960 having a recess axis 940. The recess 960 extends from an opening 932 in a first surface 934 of the sidewall of the body portion 912 toward an opposing second surface 936 of the sidewall of the body portion 912 ( Fig. 12C ). The sidewall of the main body portion 912 extends away from the recess 960 along a longitudinal axis 942 that is at a non-zero angle relative to the recess axis 940. The retraction member 226 extends through the recess 960 and away from the main body portion 912 of the annuloplasty structure 910 via the recess 960.

[0457] The recess 960 is shaped to define a recess lumen 962. The recess lumen 962 is disposed along the recess axis 940.

[0458] For some applications, body portion 912 includes a housing 930 coupled to sleeve 26. For such applications, housing 930 defines at least a portion of the sidewall, and housing 930 defines recess 960. Sleeve 26 defines the remainder of the sidewall.

[0459] For some applications, structure 910 does not include housing 930 , and sleeve 26 defines sidewalls.

[0460] The recess 960 is shaped to receive the lock 950. The recess 960 is sized to compress the lock 950 when the lock 950 is at least partially disposed within the recess 960. The lock 950 is shaped to define a series of tapered sections 951. Each section 951 has a longest length L1 of 0.2 mm to 1.5 mm. The most proximal 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, so that the walls defining the recess 960 compress the lock when the lock 950 is slid into the recess 960. That is, the portion of the recess 960 that receives the longest length L1 of the section 951 has a longest length L3 of 0.2 mm to 1.5 mm. The most proximal portion of the recess 960 has a length L4 of 0.2 mm to 2 mm.

[0461] The lock 950 is shaped to define a lock cavity configured to surround the retraction member 226. The lock 950 is shaped to define a longitudinal slit 952 extending from the proximal surface of the lock 950 toward the distal surface of the lock 950. For some applications, the slit 952 defines a lock cavity of the lock 950. The slit 952 enables the lock 950 to squeeze into the smaller recess 960 and thereby be compressed. When the lock 950 is compressed, the slit 952 enables the lock 950 to close around the retraction member 226 and thereby enables the lock 950 to lock to the retraction member 226.

[0462] For some applications (not shown), the locking lumen has a consistent size (eg, diameter) along the length of the locking lumen from the proximal surface of lock 950 to the distal surface of lock 950 .

[0463] As shown, 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 such applications, the most proximal portion of the recess 960 is narrower than any other portion of the recess 960 away from the most proximal portion.

[0464] Delivery tool 920 is used to deliver lock 950 to recess 960. Delivery tool 920 may be the same as described above with reference to FIG. FIG. 4A to FIG. 11C The described tools 300, 600, 702 and 810 are the same or substantially similar and like reference numerals represent like parts. Tool 920 includes a contraction member cut-off portion 921 which may include elements of tools 300, 600, 702 and 810 described above with respect to the cutting element.

[0465] like Fig. 12A As shown, the delivery tool 920 delivers the annuloplasty structure or the annuloplasty structure 910 and the lock 950 together toward the annulus. The delivery tool 920 and the contraction member 226 can slide relative to each other. When the delivery tool 920 is coupled to the annuloplasty structure 910, a portion of the contraction member 226 (e.g., the second portion 916) is disposed within the lumen of the delivery tool 920, and the lock 950 surrounds a portion of the contraction member. When the delivery tool 920 is coupled to the annuloplasty structure 910, the lock 950 is completely disposed proximal to the recess 960.

[0466] Fig. 12BThe lock 950 is shown in a partial position within the proximal portion of the recess 960. During the partial positioning of the lock 950, the distal portion of the lock 950 is compressed (e.g., the distal-most tapered section 951). Because the distal portion of the lock cavity of the lock 950 is wider than the proximal portion of the lock cavity, 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 retraction member 226, so that at this stage, the lock 950 is not locked relative to the retraction member 226, which will pull the retraction member distally when 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 proximal portion of the recess 960 is narrower than any other portion of the recess 960 distal to the proximal portion, and because the lock cavity of the lock 950 is narrowed 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 so as to lock the lock 950 to the contraction member and thereby maintain the periphery of the annuloplasty 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 moves the lock from an open state (such as Fig. 12A as shown) into a closed state (as shown Fig. 12C ), so as to clamp the lock 950 onto the retraction member 226 passing therethrough.

[0467] like Fig. 12C As shown, the lock 950 is shaped to fit completely within the recess 960. FIG. 4A to FIG. 11C As described above with respect to tools 300, 600, 702, and 810, tool 920 is configured to cut off excess portions of retraction member 226 after lock 950 is locked to retraction member 226 by being positioned within 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. Additionally, as described above, retraction member 226 is disposed proximate to the sharp edge such that movement of lock-ejector 923 against the sharp edge cuts off retraction member 226 extending through lock 950.

[0468] Reference now FIG. 13A to FIG. 13C , which is a schematic diagram of an example of a system 1000 including an exemplary annuloplasty structure or annuloplasty structure 910 (e.g., annuloplasty ring structure, a closed annuloplasty structure, a closed annuloplasty ring structure, an open annuloplasty structure, a partial annuloplasty ring structure, etc.) that includes a sleeve 26, a retraction member 226, and a lock 1950. The system 1000 is similar to the system 1000 described above with reference to FIG. 1 , except for the differences described below. FIG. 12A to FIG. 12CThe system 900 described is the same or substantially similar, except that the lock 1950 is at least partially disposed and retained within the recess 1960 when the delivery tool 920 is coupled to the annuloplasty structure 910. As shown, the distal-most tapered section 951 is disposed within a proximal portion of the recess 1960. In this manner, the system 1000 reduces the likelihood of embolism and / or coagulation.

[0469] Reference now FIG. 10A to FIG. 13C .exist Fig. 10A , tool 702 includes an outer sheath 710 located at least at a distal portion of tool 702. Outer sheath 710 includes a holder 720 configured to surround at least a portion of an annuloplasty structure coupled to tool 702. For some applications, any of tools 300, 600, and 810 described herein include an outer sheath 710 that includes holder 720. Holder 720 and outer sheath 710 are configured to provide a reaction force to the annuloplasty structure during deployment of fasteners 360 and / or locks 950 described herein as the fasteners 360 and / or locks 950 are pushed by the tool in order to deploy the fasteners 360 and / or locks 950. For some applications, the tools described herein do not include holder 720.

[0470] Reference now Fig.14 , which is a schematic diagram of an exemplary system 1100 according to some applications, the system including a lock 1110 configured to lock the perimeter of an annuloplasty structure (e.g., annuloplasty ring structure, closed annuloplasty structure, closed annuloplasty ring structure, open annuloplasty structure, partial annuloplasty ring structure, etc.). Except for the differences described below, the lock 1110 can be similar to the above-referenced FIG. 12A to FIG. 13C The lock 950 described is generally similar and like reference numerals refer to like parts. The slit 952 of the lock 1110 is uniform along the longitudinal axis of the lock 1110 from the proximal end of the lock 1110 to the distal end of the lock 1110. For some applications, such as FIG. 12A to FIG. 13C As shown, the lock cavity is uniform. For some applications, such as FIG. 15A to FIG. 15C As shown, the lock cavity is narrower at the proximal end portion of the lock and wider at the distal end portion.

[0471] The lock 1110 can be used to lock any of the annuloplasty structures described herein. For example, the lock 1110 can be used to lock the annuloplasty structure described above with reference to Figures 1 to 13C Any of the annuloplasty structures 222, 522, 730 and 910 described above.

[0472] The delivery tool can be used to deliver the lock 1110 toward the annuloplasty structure or annuloplasty ring structure. FIG. 4A to FIG. 13CThe tools 300, 600, 702, 810 and 920 described are the same or substantially similar and like reference numerals represent like parts. The delivery tool includes a contraction member cut-off portion that may include elements of the tools 300, 600, 702, 810 and 920 described above with respect to the cutting element.

[0473] Reference now FIG. 15A to FIG. 15C , which is a schematic diagram of an exemplary system 1480 including an exemplary annuloplasty structure 910 (e.g., annuloplasty ring structure, a closed annuloplasty ring structure, a closed annuloplasty ring structure, an open annuloplasty structure, a partial annuloplasty ring structure, etc.) according to some applications, the annuloplasty structure including a sleeve 26, a retraction member 226, and a lock 1490. System 1480 is similar to the above-referenced system except for the differences described below. FIG. 13A to FIG. 13C The described system 1000 is the same or substantially similar, except that the lock 1490 has a lumen that is narrower at a proximal end portion of the lock 1490 and wider at a distal end portion of the lock 1490 . Fig.15A Section AA of FIG. 1490 shows that the lock lumen surrounding the retraction member 226 at the proximal end portion of the lock 1490 is wider than the width of the lock lumen surrounding the retraction member 226 at the distal end portion of the lock 1490 shown in section BB. Fig. 15C As shown, once the lock 1490 is fully disposed within the recess 960, the proximal end portion is tightly closed around the retraction member 226, as shown in section CC, while the distal end portion is closed around the retraction member 226, as shown in section DD, which may not be as tightly closed around the retraction member 226 as the proximal end portion.

[0474] As shown, the lock 1490 is shaped to define a slot 952 that is narrower at a proximal end portion of the lock 1490 and wider at a distal end portion of the lock 1490 .

[0475] For some applications, such as Fig.14 As shown, the lock 1490 is shaped to define a slot 952 that is uniform along the length of the lock 1490 .

[0476] For some applications, when delivery tool 920 is coupled to annuloplasty structure 910, lock 1490 is disposed completely proximal to recess 1960, such as FIG. 12A to FIG. 12C shown.

[0477] Reference now Fig.16, which is a schematic diagram of an example of an exemplary system 1200 including an exemplary annuloplasty structure 1210 (e.g., an annuloplasty ring structure, a closed annuloplasty structure, a closed annuloplasty ring structure, an open annuloplasty structure, a partial annuloplasty ring structure, etc.) that includes a sleeve 26, a contraction member 226, and a lock 1220. The implantable annuloplasty structure 1210 includes a body portion. The contraction member 226 has a first portion extending along a longitudinal length of the body portion of the annuloplasty structure 1210 and a second portion extending away from the main portion of the annuloplasty structure 1210. The contraction member 226 is configured to adjust the circumference of the annuloplasty structure 1210.

[0478] The annuloplasty structure 1210 may be similar to the annuloplasty structure 1210 described above, except for the differences described below. Figures 1 to 15C The depicted annuloplasty structures 222, 522, 730, and 910 are the same or substantially similar, and like reference numerals refer to like components.The annuloplasty structure 1210 may be a full (or closed) or partial (or open) annuloplasty structure.

[0479] The structure 1210 includes a housing 1202 shaped to define a sidewall 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 constriction member lumen wall 1205 disposed along a constriction member lumen 1204. The constriction member lumen 1204 is disposed at a non-zero angle relative to a recess axis 1207 of the recess 1230. The recess 1230 is shaped to define a recess lumen disposed along the recess axis 1207.

[0480] The lock 1220 is shaped to define a lock threaded portion 1222. The housing 1202 of the annuloplasty structure 1210 is shaped to define annuloplasty structure threaded portion 1232 configured to engage with the lock threaded portion 1222. To advance the lock 1220 within the recess 1230 of the housing 1202, the physician uses a delivery tool to screw the lock 1220 into the housing 1202. The delivery tool may be the same as described above with reference to FIG. 4A to FIG. 13C The tools 300, 600, 702, 810 and 920 described are the same or substantially similar and like reference numerals represent like parts. The delivery tool includes a contraction member cut-off portion that may include elements of the tools 300, 600, 702, 810 and 920 described above with respect to the cutting element.

[0481] When the lock 1220 is disposed within the recess, the distal surface of the distal end of the lock 1220 is configured to press a first portion of the retraction member 226 against the retraction member lumen wall 1205 to lock the retraction member 226 at least at the first compression point 1212 .

[0482] For some applications, housing 1202 defines at least a portion of a sidewall of annuloplasty structure 1210 , and housing 1202 defines recess 1230 .

[0483] The lock 1220 is shaped to define a lock cavity 1221 configured to surround the retraction member 226. The lock 1220 is shaped to define a longitudinal slit extending from the proximal surface of the lock 1220 toward the distal surface of the lock 1220. For some applications, the slit defines the lock cavity 1221 of the lock 1220. The slit enables the lock 1220 to be squeezed into the smaller recess 1230 and thereby compressed. When the lock 1220 is compressed, the slit enables the lock 1220 to close around the retraction member 226 and thereby enables the lock 1220 to lock to the retraction member 226.

[0484] For some applications, lock cavity 1221 has a consistent dimension (eg, diameter) along the length of lock cavity 1221 from a proximal surface of lock 1220 to a distal surface of lock 1220 .

[0485] Reference now FIG. 15A to FIG. 15C and Fig.16 For some applications, lock cavity 1221 of lock 1220 is shaped to define a wider distal portion than a proximal portion of lock cavity 1221. For such applications, the proximal-most portion of recess 1230 can be narrower than any other portion of recess 1230 distal from the proximal-most portion.

[0486] Reference now FIG. 12A to FIG. 12C , FIG. 13A to FIG. 13C , FIG. 15A to FIG. 15C and Fig.16 For some applications, the slit of lock 1220 is wider at a distal end portion of lock 1220 and narrower at a proximal end portion of lock 1220 .

[0487] Reference now Fig.14 and Fig.16 For some applications, the slit of lock 1220 is uniform along the length of the slit. For some applications, lock cavity 1221 is uniform along the length of lock 1220.

[0488] Reference now Fig.17, which is a schematic diagram of an example of an exemplary system 1300 including an exemplary annuloplasty structure 1310 (e.g., an annuloplasty ring structure, a closed annuloplasty structure, a closed annuloplasty ring structure, an open annuloplasty structure, a partial annuloplasty ring structure, etc.) that includes a sleeve 26, a contraction member 226, and a lock 1320. The implantable annuloplasty structure 1310 includes a body portion. The contraction member 226 has a first portion extending along a longitudinal length of the body portion of the annuloplasty structure 1310 and a second portion extending away from the main portion of the annuloplasty structure 1310. The contraction member 226 is configured to adjust the circumference of the annuloplasty structure 1310.

[0489] The annuloplasty structure 1310 may be similar to the annuloplasty structure 1310 described above, except for the differences described below. Figures 1 to 15C The depicted annuloplasty structures 222, 522, 730, and 910 are the same or substantially similar, and like reference numerals refer to like components.The annuloplasty structure 1310 may be a full (or closed) or partial (or open) annuloplasty structure.

[0490] The structure 1310 includes a housing 1302 that is shaped to define a sidewall and is shaped to define a recess 1330 having a recess axis. The recess 1330 extends from an opening in a first surface of the housing toward an opposing second surface of the housing 1302. The housing 1302 is shaped to provide a constriction member lumen wall 1305 disposed along a constriction member lumen 1304. The constriction member lumen 1304 is disposed at a non-zero angle relative to a recess axis 1307 of the recess 1330. The recess 1330 is shaped to define a recess lumen disposed along the recess axis 1307.

[0491] The lock 1320 is shaped to define a lock threaded portion 1222. The housing 1302 of the annuloplasty structure 1310 is shaped to define annuloplasty structure threaded portion 1332 configured to engage with the lock threaded portion 1322. To advance the lock 1320 within the recess 1330 of the housing 1302, the physician uses a delivery tool to screw the lock 1320 into the housing 1302. The delivery tool may be the same as described above with reference to FIG. 4A to FIG. 13C The tools 300, 600, 702, 810 and 920 described are the same or substantially similar and like reference numerals represent like parts. The delivery tool includes a contraction member cut-off portion that may include elements of the tools 300, 600, 702, 810 and 920 described above with respect to the cutting element.

[0492] When the lock 1320 is disposed within the recess, the distal surface of the distal end of the lock 1320 is configured to squeeze a first portion of the contraction member 226 against the contraction member lumen wall 1305 to lock the contraction member 226 at least at the first compression point 1312. The lock 1320 is shaped to define a lock cavity 1321 and a lock distal tapered portion 1334 along a longitudinal length. The housing 1302 and the recess 1330 are shaped to define a recess distal tapered portion 1324. When the lock 1320 is disposed in the recess 1330 and the lock distal tapered portion 1334 is located in the recess distal tapered portion 1324, the recess distal tapered portion 1324 is configured to compress the lock distal tapered portion 1334, which in turn is configured to squeeze the second portion of the contraction member 226 in the lock cavity 1321 at the recess distal tapered portion 1324 so as to lock the contraction member 226 at least at the second squeezing point 1314.

[0493] For some applications, housing 1302 defines at least a portion of a sidewall of annuloplasty structure 1310 , and housing 1302 defines recess 1330 .

[0494] The lock cavity 1321 is configured to surround the retraction 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 lock cavity 1321 of the lock 1320. The slit enables the lock 1320 to squeeze into the smaller recess 1330 and be compressed thereby. When the lock 1320 is compressed, the slit enables the lock 1320 to close around the retraction member 226 and thereby enables the lock 1320 to lock to the retraction member 226.

[0495] For some applications, lock cavity 1321 has a consistent dimension (eg, diameter) along the length of lock cavity 1321 from a proximal surface of lock 1320 to a distal surface of lock 1320 .

[0496] Reference now FIG. 15A to FIG. 15C and Fig.17 For some applications, lock cavity 1321 of lock 1320 is shaped to define a wider distal portion than a proximal portion of lock cavity 1321. For such applications, the proximal-most portion of recess 1330 can be narrower than any other portion of recess 1330 distal from the proximal-most portion.

[0497] Reference now FIG. 12A to FIG. 12C , FIG. 13A to FIG. 13C , FIG. 15A to FIG. 15C and Fig.17 For some applications, the slit of lock 1320 is wider at a distal end portion of lock 1320 and narrower at a proximal end portion of lock 1320 .

[0498] Reference now Fig.14 and Fig.17 For some applications, the slit of lock 1320 is uniform along the length of the slit. For some applications, lock cavity 1321 is uniform along the length of lock 1320.

[0499] Reference now Figure 16 to Figure 17 The systems 1200 and 1300 provide a locking assembly that allows the operating physician to readjust the circumference of the annuloplasty structure after locking. For example, if the physician wishes to readjust once the locks 1220 and 1320 are in place, the physician can loosen the locks 1220 and 1230, respectively, to readjust the circumference of the annuloplasty structure by loosening or tightening the contraction member 226 without disengaging the locks 1220 and 1300 from the respective recesses 1230 and 1330. After readjustment of the contraction member 226, the locks 1220 and 1320 are repositioned within the respective recesses 1230 and 1330.

[0500] Reference now Fig.18 , which is a schematic diagram of an example of a system 1350 for constricting a patient's annulus 240 using an annuloplasty structure 522 (e.g., an annuloplasty ring structure, a closed annuloplasty structure, a closed annuloplasty ring structure, an open annuloplasty structure, a partial annuloplasty ring structure, etc.), which can include a housing 530. The housing 530 can house a constriction member fastener 1360. The annuloplasty structure 522 can be similar to the above-referenced system 1350 except for the differences described below. Figures 1 to 7E The depicted annuloplasty structures 222 are identical or substantially similar, and like reference numerals refer to like components.

[0501] The annuloplasty structure or annuloplasty ring structure 522 may include a sleeve 26 that may define a main body portion of the structure 522. The structure 522 includes a contraction member 226 having a first portion extending along a longitudinal length of the main body portion of the annuloplasty structure 522. The contraction member 226 also defines a second portion extending away from the main body portion of the annuloplasty structure 522.

[0502] The contraction member 226 can extend through the housing 530 and through a stopper 570 (e.g., a retainer) disposed within the opening of the contraction member fastener 1360. By way of illustration and not limitation, the stopper 570 is shown as being cylindrical. The outer surface of the stopper 570 retains the fastener 1360 in an open state. The stopper 570 is shaped to define a threaded portion that enables the contraction member receiving tool 600 to be coupled thereto, as described above.

[0503] Use the above reference Figures 1 to 3I The system, as mentioned above FIG. 3A to FIG. 3IThe annuloplasty structure or annuloplasty ring structure 522 is implanted.

[0504] The housing 530 can be coupled to the sleeve 26 of the structure 522 at any suitable position along the structure 522. For example, as shown, the housing 530 can be coupled to the sleeve 26 of the structure 522 at a portion of the left fiber trigone of the structure 522 adjacent to the valve. For some applications, the housing 530 can be coupled to the sleeve 26 of the structure 522 at a portion of the right fiber trigone of the structure 522 adjacent to the valve. For some applications, the housing 530 can be coupled to the sleeve 26 of the structure 522 at a middle portion of the structure 522. As shown, the housing 530 can be coupled to the side surface of the sleeve 26. In such applications, the housing 530 does not block the lumen of the sleeve 26 of the structure 522.

[0505] Fastener 1360 is substantially similar to FIG. 8A to FIG. 8D The fastener 360, except that the fastener 1360 is formed to define intersecting slits 1362, which form an opening of the fastener 1360 through which the retraction member 226 passes into a generally "X" or generally "+" (plus sign) shape.

[0506] Fig.18 The contraction member 226 is shown cut near the fastener 1360, and the excess portion of the contraction member 226 is removed from the patient's body using the tool 600. The cutting of the contraction member 226 can be performed as described above with reference to 7A to 7E The above-described method is implemented mutatis mutandis.

[0507] Reference now FIG. 19A to FIG. 19B , which is a schematic diagram of an example of a system 1400 for constricting a patient's annulus using an annuloplasty structure (e.g., an annuloplasty ring structure, a closed annuloplasty structure, a closed annuloplasty ring structure, an open annuloplasty structure, a partial annuloplasty ring structure, etc.), which can be coupled to a housing 1430. Housing 1430 can house constriction member fasteners 1460. For some applications, the annuloplasty structure can be used with the above reference Figures 1 to 7E The annuloplasty structure 222 described is the same or substantially similar, and like reference numerals represent like parts. For some applications, the annuloplasty structure includes a housing 1430. For some applications, the housing 1430 is separate from the annuloplasty structure and can be delivered and coupled to the annuloplasty structure only when the annuloplasty structure has been anchored to the annulus.

[0508] The housing 1430 may be coupled to the sleeve 26 of the annuloplasty structure at any suitable location along the annuloplasty structure. For example, as shown, the housing 1430 may be coupled to the sleeve 26 of the annuloplasty structure at a portion of the left fibrous trigone of the annuloplasty structure adjacent to the valve. For some applications, the housing 1430 may be coupled to the sleeve of the annuloplasty structure at a portion of the right fibrous trigone of the annuloplasty structure adjacent to the valve. For some applications, the housing 1430 may be coupled to the sleeve of the annuloplasty structure at a middle portion of the annuloplasty structure. As shown, the housing 1430 may be coupled to a side surface of the sleeve. In such applications, the housing 1430 does not block the lumen of the sleeve of the annuloplasty structure.

[0509] The annuloplasty structure or annuloplasty ring structure may include a sleeve that may define a main body portion of the structure. The structure includes a contraction member 226 having a first portion extending along the longitudinal length of the main body portion of the annuloplasty structure. The contraction member also defines a second portion extending away from the main body portion of the annuloplasty structure.

[0510] The fastener 1460 is shaped to define a generally rectangular flat clamp comprising a superelastic material (e.g., Nitinol). The fastener 1460 includes a deformable element shaped to define a plurality of slits surrounded by a plurality of flexible legs 1462 that enable the clamp to be in an inclined state ( Fig.19A ) and the straight state ( Fig.19B ) between the contraction member 226 and the fastener 1460. The contraction wire engaging 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 teeth 1464 and is flat. The teeth 1464 are configured to increase friction between the contraction member 226 and the fastener 1460.

[0511] The fastener 1460 includes a clamping structure that is (a) oriented to assume a closed state ( Fig.19B ) biased. In a closed state, the clamping structure is configured to clamp on the contraction member 226 passing therethrough, and (b) be flexible to an open state (b) in which the contraction member 226 can move therethrough. Fig.19A ).

[0512] The contraction member 226 can extend through the channel 1434 of the housing 1430 and through a stop 1470 (e.g., a retainer) disposed within an opening of the contraction member fastener 1460. The channel 1434 extends along the longitudinal axis 1410 of the housing 1430. The stop 1470 can be formed to define a lumen therethrough to surround the contraction member 226, and is shown to be formed to define a larger cylindrical portion that can be engaged by a tool, and a narrower cylindrical engagement member 1472. The engagement member 1472 can be formed to fit tightly within the channel 1434 so that it pushes against the contraction wire engagement surface of the clamp and holds the fastener 1460 in an inclined state, i.e., an unlocked state of the fastener 1460. In an embodiment as shown in FIG. Fig.19A In the tilted state shown, the clip is deformed and does not push against the retraction member 226. In the tilted state, the retraction member 226 is free to move relative to the fastener 1460, the housing 1430, and the stop 1470. The retraction member 226 is pulled until it fully retracts the annuloplasty structure.

[0513] exist Fig.19B , the stopper 1470 has been disengaged and removed from the housing 1430. In the absence of force applied to the retraction wire engagement surface of the clamp by the engagement member 1472, the clamp returns to its resting, straight state and confines the retraction member 226 between the retraction wire engagement surface of the clamp and the surface 1432 (e.g., inner wall) of the housing 1430. In this way, the fastener 1460 is now in a locked state in which the clamp locks and restrains the retraction member 226.

[0514] Reference now FIG. 20A to FIG. 20F , which is a schematic diagram of an example of a portion of a multi-component tubular system 1500 including a contraction member cutting tool 1502 and a contraction member receiving tool 1600, which will be referred to hereinafter FIG. 21A to FIG. 26B The contraction member 226 is threaded through and through the contraction member cutting tool 1502 and through the contraction member receiving tool 1600. The contraction member 226 can be used as described above with reference to 4A to 5D The snare described with respect to snare 350 is captured by tool 1502. Tool 1502 can be advanced along contraction member 226 toward annuloplasty structure 1522 (e.g., annuloplasty ring structure, a closed annuloplasty structure, a closed annuloplasty ring structure, an open annuloplasty structure, a partial annuloplasty ring structure, etc.). For some applications, tool 1502 is advanced toward housing 1530 that has been coupled to structure 1522 in a manner similar to that of tool 300 along contraction member 226, as described above with reference to 4A to 5DThe annuloplasty structure 1522 may include a flexible main body portion. The contraction member 226 has a first portion extending along the longitudinal length of the main body portion. The second portion of the contraction member 226 may extend away from the main body portion of the annuloplasty structure 1522 and extend outside the patient's body.

[0515] System 1500 for constricting a patient's annulus using an annuloplasty structure 1522 (e.g., an annuloplasty ring structure, a closed annuloplasty structure, a closed annuloplasty ring structure, an open annuloplasty structure, a partial annuloplasty ring structure, etc.) may include housing 1530. Housing 1530 may house constriction member fastener 1560. Annuloplasty structure 1522 may be similar to the annuloplasty structure described above with reference to the present invention, except for the differences described below. Figures 1 to 7E The depicted annuloplasty structures 222 are identical or substantially similar, and like reference numerals refer to like components.

[0516] It should be noted that fastener 1560 may include the FIG. 4A to FIG. 4B , 7A to 7E , FIG. 8A to FIG. 8D , 9A to 9D , FIG. 10A to FIG. 10B and FIG. 11A to FIG. 11C The fastener 360 described above with reference to FIG. 12A to FIG. 12C The lock 950 described above with reference to FIG. 12A to FIG. 12C Lock 1950 described above, reference Fig.14 The lock 1110 described above FIG. 15A to FIG. 15C Lock 1490 described above with reference to Fig.16 The lock 1220 described above Fig.17 The lock 1320 described herein, or any other fastener, lock, and / or restraint known in the art.

[0517] The annuloplasty structure or annuloplasty ring structure 1522 may include a sleeve 26 that may define a main body portion of the structure 1522. The structure 1522 includes a contraction member 226 having a first portion extending along a longitudinal length of the main body portion of the annuloplasty structure 1522. The contraction member 226 also defines a second portion extending away from the main body portion of the annuloplasty structure 1522.

[0518] The contraction member 226 can extend through the housing 1530 and through a stopper 1570 (e.g., a retainer) disposed within the opening of the contraction member fastener 1560. The stopper 1570 is shaped to define a lumen therethrough to surround the contraction member 226, and is shown as being shaped to define a larger cylindrical portion that can be engaged by a tool, and a narrower cylindrical engagement piece 1574. FIG. 20A to FIG. 20DAs shown, the outer surface of the engagement member 1574 holds the fastener 1560 in an open state. The stop member 1570 is shaped to define an overhang 1572 that enables the contraction member cutting tool 1502 to be coupled thereto, as described below.

[0519] Use the above reference Figures 1 to 3I The system, as mentioned above FIG. 3A to FIG. 3I The annuloplasty structure or annuloplasty ring structure 1522 is implanted.

[0520] The housing 1530 can be coupled to the sleeve 26 of the structure 1522 at any suitable position along the structure 1522. For example, as shown, the housing 1530 can be coupled to the sleeve 26 of the structure 1522 at a portion of the structure 1522 adjacent to the left fiber trigone of the valve. For some applications, the housing 1530 can be coupled to the sleeve 26 of the structure 1522 at a portion of the structure 1522 adjacent to the right fiber trigone of the valve. For some applications, the housing 1530 can be coupled to the sleeve 26 of the structure 1522 at a middle portion of the structure 1522. As shown, the housing 1530 can be coupled to the side surface of the sleeve 26. In such applications, the housing 1530 does not block the lumen of the sleeve 26 of the structure 1522.

[0521] Fig. 20A The retraction member cutting tool 1502 is shown through which the retraction member 226 has been threaded. The retraction member 226 can be cut using the tool described above with reference to 4A to 5D The snare described with respect to snare 350 is captured by tool 1502. Tool 1502 may be advanced along contraction member 226 toward housing 1530 of structure 1522 in a manner similar to the advancement of tool 300 along contraction member 226, as described above with reference to FIG. 4A to 5D described.

[0522] Once the tool 1502 is threaded along the retraction member 226, the retraction member 226 extends from the cannula 26, through the engagement member 1574, through the proximal portion of the stopper 1570, through the cutting elements 1510 and 1520 of the tool 1502, and through the remaining proximal portion of the tool 1502. In this way, the retraction member 226 is disposed in the vicinity of the cutting elements. The retraction member 226 is disposed along the entire length of the tool 1502 along the longitudinal axis 1511 of the tool 1502. The relative spatial orientation of the components of the tool 1502 enables 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 of the member 226 through the tool 1502 reduces friction as the member 226 moves within the tool 1502. This direct path of the retraction member 226 is achieved due to the orientation of the components of the tool 1502, as opposed to the coiled path member 226 through the tools 300, 600, 810, and 920 described above. FIG. 21A to FIG. 26B As described above, the reduction in friction on the retraction member 226 reduces noise during tension measurement of the retraction member 226 .

[0523] Tool 1502 includes an inner tube 1504 that is slidable relative to an outer sleeve portion 1508. The distal end of inner tube 1504 is shaped to define a grasper 1505 or fastener-ejector. Because the distal end portion of tube 1504 is slotted, and because grasper 1505 is angled, grasper 1505 has a tendency to be urged radially outward in the presence of a force applied thereto by overhang 1572. Once tube 1504 is sufficiently urged distally, grasper 1505 bypasses overhang 1572 distally and bypasses stop 1570 at a point distal from overhang 1572, as shown in FIG. Fig. 20B By grasping the overhang 1572, the grasper 1505 provides the primary and initial coupling and locking of the tool 1502 to the housing 1530.

[0524] Tool 1502 includes a static cutting element 1510 and a movable dynamic cutting element 1520. Static cutting element 1510 is shaped to define a concave cutting surface 1512 (i.e., a sharp edge), and dynamic cutting element 1520 is shaped to define a concave cutting surface 1521 (i.e., a sharp edge) opposite concave cutting surface 1512 of static cutting element 1510. As described below, dynamic cutting element 1520 slides proximally and diagonally relative to static cutting element 1510 along concave cutting surface 1512 of static cutting element 1510.

[0525] Once the stopper 1570 is engaged by the inner tube 1504, the outer sleeve portion 1508 is moved distally along the inner tube 1504 and toward the housing 1530 until the distal end of the outer sleeve portion 1508 contacts the proximal end of the housing 1530, as shown. Fig. 20C 1570, and thereby locks the tool 1502 in place relative to the housing 1530. Because the graspers 1505 are angled, they are able to slide proximally around the overhang 1572 in response to the proximal pull of the tool 1502. Thus, during release of the fastener 1560, the graspers 1505 are prevented from radially moving in response to the proximal pulling force applied by the tool 1502 to the stopper 1570 by the outer sleeve portion 1508 around the slotted distal end portion of the tube 1504 and around the tube 1504, so as to lock the retraction member 226 in place and maintain the annuloplasty structure 1522 in tension, as will be described below. Thus, outer sleeve portion 1508 locks grasper 1505 relative to overhang 1572 and provides auxiliary coupling and locking of tool 1502 to housing 1530.

[0526] Static cutting element 1510 includes a pin 1513 that slides proximally and distally within a slot 1515 in tube 1404. In this way, static cutting element 1510 is coupled to tube 1404 and to the tube surrounding tube 1404. That is, pin 1513 is coupled to outer sleeve portion 1508. When outer sleeve portion 1508 moves distally, as shown in FIG. Fig. 20C As shown, pin 1513 moves distally in slot 151, and static cutting element 1510 and dynamic cutting element 1520 are pushed distally in tube 1404. In this state, distal surface 1523 of dynamic cutting element 1520 is still disposed at a distance from proximal surface 1571 of stopper 1570.

[0527] Fig.20D The annuloplasty structure 1522 is shown contracting in response to the tool 1502 pulling the contraction member 226 proximally. During the pulling of the contraction member 226, the tool 1502 remains coupled to the housing 1530 due to the grasper 1505 grasping the overhang 1572 while the outer sleeve portion 1508 surrounds the distal portion of the inner tube 1504 and around the grasper 1505.

[0528] Tool 1502 may include the retraction member receiving device 322 of tool 300, as described above with reference to FIG. 4A to FIG. 4B The contraction member receiving device can be used to contract the contraction member 226. Once the contraction member 226 is contracted and the structure 1522 is contracted, as shown in FIG. Fig.20DAs shown, tool 1502 removes stopper 1570 by pulling stopper 1570 proximally away from fastener 1560, as shown in FIG. Fig.20E While maintaining distal force on outer sleeve portion 1508, tube 1404 is pulled proximally relative to portion 1508. Due to the presence of outer sleeve portion 1508, grasper 1505 remains grasped on overhang 1572 of stopper 1570, thereby pulling stopper 1570 proximally. During the proximal pulling of tube 1504, outer sleeve portion 1508 prevents radial outward movement of grasper 1505 when proximal force is applied to tube 1504. Tube 1504 is pulled proximally until stopper 1570 disengages from housing 1530, i.e., until engagement member 1574 of stopper 1570 separates and disengages from fastener 1560, as shown. Fig.20E As the fastener 1560 tends to close, in the absence of the stopper 1570, the fastener 1560 closes and clamps around the contraction member 226 passing through the fastener 1560. In this way, the structure 1522 is locked by the fastener 1560, and the contracted state of the structure 1522 is maintained.

[0529] When the stopper 1570 is pulled proximally, the proximal surface of the stopper 1570 hammers into the distal surface 1523 of the dynamic cutting element 1520. In response to the stopper 1570 pushing against the dynamic cutting element 1520, the dynamic cutting element 1520 is pushed proximally, so that the dynamic cutting element 1520 moves diagonally proximally. The cutting surface 1521 of the dynamic cutting element 1520 and the cutting element 1520 slide diagonally proximally along the cutting surface 1512 of the static cutting element 1510. The portion of the contraction member 226 disposed between the cutting surfaces 1512 and 1521 is cut off. Since the cutting surfaces 1512 and 1521 are concave and face each other, during cutting, the surfaces 1512 and 1521 compress the contraction member 226, thereby cutting the contraction member 226 cleanly and without wear.

[0530] Thus, the tool 1502 is arranged such that the tool 1502 advantageously provides a safety mechanism by which the retraction member 226 can only be severed by a proximal force applied thereto by the stop 1570 after the fastener 1560 has been transitioned to the fastened or locked state and locked in place the retraction member 226. That is, the tool 1502 will not inadvertently sever the retraction member 226 during the entire time that the tool 1502 is not coupled to the stop 1570 and the entire time that the stop 1570 is not pushed against the cutting element 1520. In one rapid motion, the tool 1502 (1) locks the retraction member 226 in place by transitioning the fastener 1560 to the locked state, and (2) severs the retraction member 226.

[0531] Fig.20F The retraction member 226 is shown after being cut near the fastener 1560 and the excess portion of the retraction member 226 is removed from the patient's body using the tool 1502. The entire tool 1502 is pulled proximally to separate the tool 1502 from the housing 1530 and from the structure 1522 carrying the stopper 1570 within the lumen of the tool 1502. Since the stopper 1570 is no longer coupled to the housing 1530, a simple proximal pull on the tool 1502 is sufficient to separate the tool 1502 from the annuloplasty structure 1522.

[0532] Reference again FIG. 20A to FIG. 20F It should be noted that although tool 1502 is described as being advanceable toward housing 1530 already coupled to annuloplasty structure 1522, the scope herein includes tool 1502 being coupled to housing 1530 from a site outside the patient's body and cannula 26 being configured to deliver housing 1530 along retraction member 226 to structure 1522 already implanted at the annulus. For such applications, housing 1530 is configured to be positionable against the main body portion of structure 1522.

[0533] Reference now FIG. 21A to FIG. 26B , which is a schematic diagram of another portion of a multi-component tubular system 1500 according to some applications, referenced above FIG. 20A to FIG. 20F Described, includes a contraction member receiving tool 1600 configured to contract the flexible, elongated contraction member 226. FIG. 21A to FIG. 21B The retraction member receiving tool 1600 is shown prior to insertion of the flexible elongated retraction member 226, and FIG. 22A to FIG. 26B The retraction member receiving tool 1600 is shown after the flexible elongated retraction member 226 has been inserted.

[0534] The multi-component tubular system 1500 is used with an implant that includes an implantable structure and a flexible, elongated contraction member 226 extending away from the implantable structure. The implant may include any implant described herein, such as an implantable annuloplasty structure 222, which may, for example, include a flexible sleeve 26. Alternatively, the implant may include another implant known in the art (including those described in the patents and patent application publications incorporated by reference below), which may or may not include a sleeve.

[0535] The retraction member receiving tool 1600 includes a handle portion 1620, which is optionally supported by a bracket, such as described above with reference to Figure 1 to Figure 2 The handle portion 1620 may include one, some, or all of the following:

[0536] An outer housing 1632 that may be ergonomically shaped to be held by a user (e.g., a physician, a healthcare professional, etc.);

[0537] a tubular shaft 1634 disposed at least partially within the outer housing 1632;

[0538] an inner shaft 1636 that is (a) partially disposed within a proximal longitudinal portion 1637 of the tubular shaft 1634 such that the inner shaft 1636 is axially slidable relative to the tubular shaft 1634 and (b) shaped to define an inner shaft retraction member receiving passage 1638;

[0539] a distal force applicator 1642 that is (a) at least partially disposed within a distal longitudinal portion of the tubular shaft 1634 and (b) shaped to define a distal force applicator retraction member receiving channel 1644 that allows the retraction member 226 to slide therethrough;

[0540] a spring 1646 disposed within the tubular shaft 1634 connecting the distal force applicator 1642 and a distal portion 1647 of the inner shaft 1636; and

[0541] • A contraction facilitating knob 1630 which is accessible from outside the outer housing 1632 .

[0542] The handle portion 1620 is shaped to define a handle retraction member receiving passage 1650 from a distal end to a proximal end of the handle portion 1620 (as used in this application, including in the claims, "proximal" means toward the user, i.e., away from the implant; refer to FIG. 21A to FIG. 26B , “proximal” means to the right in the drawings). The handle retraction member receiving channel 1650 includes the inner shaft retraction member receiving channel 1638, the distal force applicator retraction member receiving channel 1644, and optional additional retraction member receiving channels of the handle portion 1620. A portion of the retraction member 226 is threaded through the handle retraction member receiving channel 1650 after or before the implantable structure and retraction member 226 are advanced toward the patient's heart.

[0543] The inner shaft 1636 may include a lock 1640 configured to (i) allow the contraction member 226 to slide relative to the inner shaft contraction member receiving channel 1638 when in an unlocked state, and (ii) axially lock the contraction member 226 relative to the inner shaft 1636 when in a locked state. Optionally, the lock 1640 applies friction to axially lock the contraction member 226 relative to the inner shaft 1636, such as using a set of screws or levers, as is known in the art.

[0544] The handle portion 1620 is configured such that when the retraction member 226 is disposed completely through the handle retraction member receiving channel 1650 and the lock 1640 is in the locked state, actuating the retraction facilitating knob 1630 causes the handle portion 1620 to receive a continuing portion of the retraction member 226 . FIG. 22A to FIG. 22B The handle portion 1620 is shown prior to actuation of the retraction facilitating knob 1630 when the retraction member 226 is disposed completely through the handle retraction member receiving channel 1650 and the lock 1640 is in a locked state. FIG. 23A to FIG. 23B , FIG. 24A to FIG. 24B and FIG. 25A to FIG. 25B The handle portion 1620 is shown after successive levels of actuation of the contraction facilitating knob 1630, as described below.

[0545] like FIG. 21A to FIG. 21B and FIG. 22A to FIG. 22B As shown, the portion of the contraction member 226 between the handle portion 1620 and the implant may be slightly relaxed or at most minimally tensioned prior to initial actuation of the contraction facilitation knob 1630. The proximal end 1652 of the tubular shaft 1634 and the proximal end 1654 of the inner shaft 1636 are disposed at an initial offset distance D1 therebetween, which indicates that there is substantially no tension in the contraction member 226, i.e., the contraction member 226 is not tensioned. For applications in which the implant comprises an implantable annuloplasty structure 222, the implantable annuloplasty structure comprises a flexible sleeve 26, which (coupled to the annulus 240) is in a relaxed, non-tensioned state. At this point, the tool has been sufficiently advanced through the patient's vasculature such that the distal tip of the tool is proximal to the structure 222 disposed along the annulus.

[0546] For example, as shown in the figure, FIG. 22A to FIG. 22B and FIG. 23A to FIG. 23B In the transition between, actuation of the contraction facilitating knob 1630 can cause the handle portion 1620 to receive a continuous portion of the contraction member 226 by:

[0547] Advancing tubular shaft 1634 proximally relative to outer housing 1632,

[0548] which advances the distal force applicator 1642 proximally relative to the outer housing 1632 (the distal force applicator 1642 may be axially fixed to the tubular shaft 1634 during conventional use of the handle portion 1620),

[0549] It applies a proximally directed force to spring 1646,

[0550] It pushes the inner shaft 1636 proximally relative to the outer housing 1632 (through the spring 1646 applying a proximally directed force to the inner shaft 1636,

[0551] This pulls the retraction member 226 proximally (which is axially locked to the inner shaft 1636 by the lock 1640, as described above).

[0552] Sometimes, in FIG. 22A to FIG. 22B and FIG. 23A to FIG. 23B During the initial proximal movement of the distal force applicator 1642 relative to the outer housing 1632 shown in the transition between , the contraction member 226 is relatively relaxed, as described above, such that the inner shaft 1636 provides no resistance or relatively little resistance to the proximally directed force applied to the inner shaft 1636 by the spring 1646, and the spring 1646 is not axially compressed or is only minimally axially compressed. Therefore, the inner shaft 1636 is proximally advanced relative to the outer housing 1632 to the same or approximately the same extent as the tubular shaft 1634 is proximally advanced relative to the outer housing 1632, and the offset distance is maintained at its initial value (D1), indicating that there is substantially no tension in the contraction member 226. This initial proximal advancement of the tubular shaft 1634 and the inner shaft 1636 relative to the outer housing 1632 is used to accommodate different initial degrees of relaxation in the contraction member 226.

[0553] As the distal force applicator 1642 is proximally advanced a certain distance relative to the outer housing 1632, the contraction member 226 becomes tensioned (at an initial low tension level) such that the inner shaft 1636 gradually provides increasing resistance to the proximally directed force applied to the inner shaft 1636 by the spring 1646, and the spring 1646 gradually becomes more compressed. As used in this application, including in the claims, the contraction member 226 is considered to be "tensioned," even when tensioned at a low level of tension.

[0554] like FIG. 23A to FIG. 23B and FIG. 24A to FIG. 24B As shown in the transition between , 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 proximally advanced relative to the outer housing 1632, and the proximal pulling of the contraction member 226 by the inner shaft 1636 increases the tension in the contraction member 226. Therefore, 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 tensioning offset distance D2, as shown in FIG. FIG. 24A to FIG. 24B (In actual use of the handle, many tensioning offset distances D2 occur; for illustration purposes, a single offset is shown.) The tensioning offset distance D2 is less than the initial offset distance D1, reflecting the fact that the portion of the inner shaft 1636 protruding from the proximal end 1652 of the tubular shaft 1634 has been reduced.

[0555] The contraction facilitating knob 1630 can have any shape that enables it to be actuated, and is not necessarily circular, tubular, or generally cylindrical. For example, for some applications, the contraction facilitating knob 1630 is configured to be actuated by its rotation (e.g., around the central longitudinal axis of the tubular shaft 1634), as shown in the accompanying drawings. Optionally, for some applications, the contraction facilitating knob 1630 is configured to be actuated by its axial sliding relative to the outer housing 1632 (configuration not shown). The contraction facilitating knob 1630 can be non-electrical, i.e., completely mechanical, or can optionally include electrical components, including, for example, circuitry.

[0556] For some applications, tubular shaft 1634 and contraction facilitating knob 1630 are threadedly coupled to one another, and handle portion 1620 is configured such that actuation of contraction facilitating knob 1630 rotates tubular shaft 1634, thereby advancing tubular shaft 1634 proximally relative to outer housing 1632. For some of these applications, contraction facilitating knob 1630 is configured to be actuated by rotation thereof (e.g., about a central longitudinal axis of tubular shaft 1634), as shown in the figures.

[0557] For some applications, handle portion 1620 also includes an inner stabilizing tube 1680 that (a) extends proximally from distal force applicator 1642 and is axially fixed thereto, and (b) defines a portion of handle retraction member receiving passage 1650 therethrough. A portion of inner stabilizing tube 1680 is disposed within inner shaft retraction member receiving passage 1638; the length of the portion varies with the distance between distal force applicator 1642 and inner shaft 1636. Spring 1646 can be configured to surround a portion of inner stabilizing tube 1680 and to be free to move axially relative to an outer surface of inner stabilizing tube 1680.

[0558] For some applications, the inner shaft 1636 partially protrudes out of the proximal end 1639 of the outer housing 1632 so that a portion of the inner shaft 1636 is visible to a user. For these applications, the tubular shaft 1634 and the inner shaft 1636 together provide a non-electrical mechanical dynamometer 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 the measure of tension in the contraction member 226. The tubular shaft may also protrude out of the proximal end 1639 of the outer housing 1632, at least after the tubular shaft 1634 begins to be advanced proximally. For these applications, the inner shaft 1636 may be marked with a plurality of fiducial markers 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 disposed at an initial offset distance D1 therebetween, the fiducial marker 1626 may provide a reading of zero or near zero, such as FIG. 22A to FIG. 22B As shown (the force applied to the spring 1646 at any given level of compression of the spring is equal to the tension in the retraction member 226).

[0559] It should be noted that the force gauge 1624 does not measure the length of the contraction member 226 that is received by the handle portion 1620 (which is equal to the distance that the inner shaft 1636 is moved proximally). As described above, an initial portion of the received length is sometimes caused by the proximal movement of the inner shaft 1636, while the tubular shaft 1634 is moved proximally in tandem with 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 contraction member 226 is received by the handle portion 1620.

[0560] More generally, the inner shaft 1636 can be considered to be an axially movable portion of the force gauge 1624. The axially movable portion of the force gauge 1624 can move axially relative to the outer housing 1632 (and typically relative to one or more other portions of the force gauge 1624, which may or may not themselves be axially movable relative to the outer housing 1632).

[0561] For some applications, the inner shaft 1636 does not protrude beyond the proximal end 1639 of the outer housing 1632, in which case the handle portion 1620 does not provide the non-electrical mechanical force gauge 1624. However, the handle portion 1620 is still fully useful for adjusting the tension in the retraction member 226, such as in a configuration in which 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 retraction member 226, as described below.

[0562] Reference again FIG. 24A to FIG. 24B and FIG. 25A to FIG. 25B . Also refer to FIG. 26A to FIG. 26B , which is a schematic diagram of a portion of the outer housing 1632 and the tubular shaft 1634 according to some applications. For clarity of illustration, the inner shaft 1636 is not shown. For some applications, the handle portion 1620 also includes a tension-limiting locking assembly 1658 that is 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 can be configured to axially lock the inner shaft 1636 relative to the outer housing 1632 when the tubular shaft 1634 is disposed at a predetermined relative axial position relative to the inner shaft 1636, thereby limiting the maximum tension that the inner shaft 1636 can apply to the contraction member 226. The tension-limiting locking assembly 1658 can also be configured to axially lock the tubular shaft 1634 relative to the outer housing 1632 when the tubular shaft 1634 is disposed at a predetermined relative axial position relative to the inner shaft 1636 .

[0563] For some applications, tension limiting locking assembly 1658 includes a pawl 1660 that is arranged to axially lock inner shaft 1636 relative to outer housing 1632 when tubular shaft 1634 is disposed at a predetermined relative axial position relative to inner shaft 1636, such as FIG. 25A to FIG. 25B As shown, the maximum tension that the inner shaft 1636 can apply to the retraction member 226 is limited.

[0564] like FIG. 24A to FIG. 24B and FIG. 25A to FIG. 25B As shown in the transition between 1646 and 1636, 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. As a result, the offset distance between the proximal end 1652 of the tubular shaft 1634 and the proximal end 1654 of the inner shaft 1636 is reduced to a maximum tensioning offset distance D3 (which, as shown, may optionally be zero or near zero), which is less than the tensioning offset distance D2 and is equal to the above-described 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 in which the handle portion 1620 provides a non-electrical mechanical dynamometer 1624, as described above.

[0565] For applications in which the implant comprises an implantable annuloplasty structure 222 comprising a flexible sleeve 26, the sleeve 26 of the annuloplasty structure 222 coupled to the annulus 240 may be in a tensioned, contracted state.

[0566] The tension limiting locking assembly 1658 optionally eliminates the need for the non-electrical mechanical dynamometer 1624 described above. Additionally, for applications in which the dynamometer 1624 is provided, the tension limiting locking assembly 1658 eliminates the need for the user to repeatedly check the readings of the dynamometer 1624, thereby allowing the user to focus on other aspects of the procedure, such as fluoroscopic images. In general, 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 that can be applied to the contraction member 226 using the contraction member receiving tool 1600.

[0567] It should be noted that the tension-limiting locking assembly 1658 generally does not axially lock the inner shaft 1636 in direct response to the length of the contraction member 226 that is received by the handle portion 1620 (the received length being equal to the distance that the inner shaft 1636 moves proximally). Additionally, the tension-limiting locking assembly 1658 generally does not axially lock the inner shaft 1636 in direct response to the relative axial movement between the inner shaft 1636 and the outer housing 1632 or in direct response to the relative axial movement between the tubular shaft 1634 and the outer housing 1632. As described above, an initial portion of the received length is sometimes caused by the proximal movement of the inner shaft 1636, while the tubular shaft 1634 moves proximally generally in tandem with the inner shaft 1636 before the contraction member 226 is tensioned. Since the tension limiting locking assembly 1658 is generally configured to axially lock the inner shaft 1636 relative to the outer housing 1632 when the tubular shaft 1634 is disposed at a predetermined relative axial position relative to the inner shaft 1636, the tension limiting locking assembly 1658 is not affected or triggered by any movement of the inner shaft 1636 and the tubular shaft 1634 in tandem with each other.

[0568] For some applications, pawl 1660 is axially fixedly coupled to inner shaft 1636 and is configured to move radially outward to engage outer housing 1632 to axially lock inner shaft 1636 relative to outer housing 1632, such as FIG. 24A to FIG. 24B For example, a pawl spring 1684 may be provided that applies a radially outwardly directed force to the pawl 1660. The handle portion 1620 is configured to be in a position to move the pawl 1684 radially outwardly when the tubular shaft 1634 is not disposed in a predetermined relative axial position relative to the inner shaft 1636. FIG. 22A to FIG. 23BAs shown, elements of handle portion 1620 prevent radial outward movement of pawl 1660, such as described below. As used in this application, including in the claims, "radially outward" means in a direction away from the central longitudinal axis of outer housing 1632, and "radially inward" means in the opposite direction toward the central longitudinal axis.

[0569] For some applications, the tension limiting locking assembly 1658 further includes the outer housing 1632 being shaped to define a plurality of indentations 1662. The pawl 1660 can engage with the indentations 1662 to axially lock the inner shaft 1636 relative to the outer housing 1632. The handle portion 1620 is arranged such that when the tubular shaft 1634 is disposed at a predetermined relative axial position relative to the inner shaft 1636, the particular one of the indentations 1662 that the pawl 1660 engages with 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 varied to accommodate different initial degrees of slack in the retraction member 226.

[0570] For some applications, wherein the proximal longitudinal portion 1637 of the tubular shaft 1634 is shaped to define an elongated opening 1664, the pawl 1660 passes through the elongated opening when the pawl 1660 axially locks the inner shaft 1636 relative to the outer housing 1632. For 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 to:

[0571] Preventing the pawl 1660 from axially locking the inner shaft 1636 relative to the outer housing 1632 (by preventing radially outward movement of the pawl 1660) when the tubular shaft 1634 is disposed distally to a predetermined relative axial position relative to the inner shaft 1636, and

[0572] • Allowing the pawls 1660 to axially lock the inner shaft 1636 (by allowing radially outward movement of the pawls 1660) when the tubular shaft 1634 is disposed in a predetermined relative axial position relative to the inner shaft 1636.

[0573] The portion of the one or more tracks 1666 that prevents the pawl 1660 from axially locking the inner shaft 1636 relative to the outer housing 1632 may be radially disposed inwardly of the portion of the one or more tracks 1666 that allows the pawl 1660 to axially lock the inner shaft 1636 .

[0574] For some of these applications, the proximal longitudinal portion 1637 of the tubular shaft 1634 includes one or more pawl supports 1688 that are fixed to the pawl 1660 and are configured to slide axially along one or more tracks 1666. When the tubular shaft 1634 is disposed distally of 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 that stabilize the one or more pawl supports 1688 during radial movement thereof; the one or more pawl supports 1688 can slide radially relative to the one or more pawl support posts 1690.

[0575] For some of these applications, the 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 disposed at a predetermined relative axial position relative to the inner shaft 1636, subsequent distally guided movement of the tubular shaft 1634 and corresponding distally guided movement of the one or more tracks 1666 relative to the inner shaft 1636 disengages the pawl 1660 from the outer housing 1632. For example, such disengagement may be caused by the one or more ramp portions 1668 causing the one or more pawl supports 1688 to slide radially inwardly and onto radially inwardly disposed portions of the one or more tracks 1665. The distally guided movement of the tubular shaft 1634 may be caused by actuating the contraction facilitating knob 1630 in a direction opposite to the actuation direction of the proximal guided movement described above. This allows the user to reduce the tension in retraction member 226 during the procedure if necessary, even if the tension level is high enough to trigger the tension-limiting lock of pawl 1660. Of course, the user can also reduce the tension in retraction member 226 even before the tension-limiting lock of pawl 1660 if necessary.

[0576] For some applications, once the desired level of tension in the contraction member 226 is achieved (by monitoring the force gauge 1624, by limiting the maximum tension with the pawl 1660, and / or, for example, by monitoring the degree of regurgitation of the valve under echocardiographic and / or fluoroscopic guidance), the contraction member containment tool 1600 locks the contraction member 226 so as to maintain the level of tension in the contraction member 226, thereby maintaining the contraction member 226 (and optionally the structure 222, if provided) in a contracted state.

[0577] For some applications, such as Fig.25BAs may be best seen in the enlarged view in FIG. 1 , the pawl 1660 and / or the indent 1662 are slightly angled (e.g., between 1 and 45 degrees, such as between 1 and 30 degrees, such as between 1 and 15 degrees, such as about 5 degrees) relative to a direction perpendicular to the central longitudinal axis of the handle portion 1620, such that the pawl 1660 faces slightly in the proximal direction and / or the opening of the indent 1662 faces slightly in the distal direction. As the pawl 1660 moves proximally before immediately engaging one of the indents 1662, this angling makes it easy for the pawl to lock and engage with the indent 1662, and also to be easily disengaged if desired, as described above. Alternatively, the pawl 1660 and / or the indent 1662 are not angled and are perpendicular to the central longitudinal axis of the handle portion 1620.

[0578] Reference again FIG. 21A to FIG. 21B For some applications, spring 1646 is preloaded when proximal end 1652 of tubular shaft 1634 and proximal end 1654 of inner shaft 1636 are disposed at an initial offset distance D1 therebetween. Typically, handle portion 1620 is configured to maintain the preload prior to use of handle portion 1620 by preventing inner shaft 1636 from being proximally advanced relative to tubular shaft 1634 beyond a predetermined maximum distance. For example, the proximal end of elongated opening 1664 (e.g., Fig. 22B ) can prevent an element of the tension limiting locking assembly 1658 (e.g., one or more of the pawl support posts 1690 or a proximal portion of one or more pawl supports 1688, such as Fig.26A The preload setting will be described immediately below.

[0579] Reference again Fig. 21B For some applications, a radially inward surface of tubular shaft 1634 proximate its distal end is shaped to define threads 1682, and a radially outward surface of distal force applicator 1642 is shaped to define corresponding threads 1686. The threads allow the precise axial position of distal force applicator 1642 relative to tubular shaft 1634 to be adjusted by rotating distal force applicator 1642 relative to tubular shaft 1634 during a calibration procedure during the manufacturing process of handle portion 1620. Such rotation can be easily performed, for example, prior to inserting tubular shaft 1634, inner shaft 1636, distal force applicator 1642, spring 1646, and other elements fixed to inner shaft 1636 into outer housing 1632. During use of handle portion 1620 in a medical procedure, as described above, distal force applicator 1642 is rotationally fixed and therefore axially fixed relative to tubular shaft 1634.

[0580] For some applications, during a calibration procedure, the axial position of the distal force applicator 1642 relative to the tubular shaft 1634 is adjusted to adjust the preload of the spring 1646 (by compressing the spring) to set a desired level of maximum tension that the inner shaft 1636 can apply to the contraction member 226. For example, a distally directed force can be applied to the proximal end 1654 of the inner shaft 1636 until the offset distance between the proximal end 1652 of the tubular shaft 1634 and the proximal end 1654 of the inner shaft 1636 is reduced to a maximum tensioning offset distance D3 (at which the tension-limiting locking assembly 1658 is triggered during subsequent use). This applied distally directed force can be measured with a dynamometer, and the axial position of the distal force applicator 1642 relative to the tubular shaft 1634 can be adjusted until the applied distally directed force is equal to the desired level of maximum tension that the inner shaft 1636 can apply to the contraction member 226 before the tension-limiting locking assembly 1658 is triggered during subsequent use. Upon removal of the calibrated distally directed force, the spring 1646 will extend until further advancement of the inner shaft 1636 is prevented, as described above, and the spring 1646 will have the desired level of preload.

[0581] Reference again Figures 1 to 26B The systems 10, 510, 700, 800, 900, 1000, 1100, 1200, 1300, 1350, 1400, 1480, and 1500 and methods for repairing a dilated annulus in a patient can be used to treat any heart valve in the patient, such as the aortic valve, the pulmonary valve, the mitral valve, and the tricuspid valve. In addition, the systems described herein for treating valves can be used to treat other annular muscles in the patient's body. For example, the systems described herein can be used to treat the sphincter in the patient's stomach.

[0582] Reference again Figures 1 to 26B Systems 10, 510, 700, 800, 900, 1000, 1100, 1200, 1300, 1350, 1400, 1480, and 1500 may be anchored to tissue of the annulus using any of the anchoring devices (including anchor drivers and deployment manipulators) described in U.S. Patent Application Publication No. 2015 / 0272734 to Sheps et al.

[0583] Reference again Figures 1 to 26B The systems 10, 510, 700, 800, 900, 1000, 1100, 1200, 1300, 1350, 1400, 1480, and 1500 and methods described above may be used with any suitable tissue of a patient (eg, gastric tissue, urinary tract, and prostate tissue).

[0584] Reference now Figures 1 to 26BThe tools described herein can be used to deploy, anchor, and adjust the perimeter of any annuloplasty structure, for example, a full (or closed) annuloplasty structure or a partial (or open) annuloplasty structure. FIG. 7A to FIG. 26B Any of the couplings described are coupled to an annuloplasty structure. For example, any of the annuloplasty structures described herein may include a housing 930 having a female coupling 927, and the tools described herein may include a male coupling 925 tool as described above with reference to FIGS. 12, 13, and 15. The annuloplasty structures described herein may include elements and structures as described in PCT Publication WO 10 / 073246 to Cabiri et al., which is incorporated herein by reference.

[0585] Additionally, the applications described in one or more of the following documents may be used with various embodiments in the present disclosure:

[0586] U.S. Patent Application 12 / 435,291 to Maisano et al., filed May 4, 2009, entitled “Adjustable repair chords and spool mechanism therefor,” issued as U.S. Patent 8,147,542;

[0587] U.S. Patent Application No. 12 / 437,103, filed May 7, 2009, to Zipory et al., entitled “Annuloplasty ring intra-ring anchoring,” which issued as U.S. Patent No. 8,715,342;

[0588] U.S. Patent Application 12 / 548,991 to Maisano et al., entitled “Implantation of repair chords in the heart,” filed on August 27, 2009, issued as U.S. Patent 8,808,368;

[0589] PCT Patent Application No. PCT / IL2009 / 001209, entitled “Adjustable annuloplasty devices and mechanisms therefor,” to Cabiri et al., filed on December 22, 2009, which issued as PCT Publication No. WO 10 / 073246;

[0590] PCT Patent Application No. PCT / IL2010 / 000357 to Maisano et al., entitled “Implantation of repair chords in the heart,” filed on May 4, 2010 and issued as WO 10 / 128502;

[0591] PCT Patent Application No. PCT / IL2010 / 000358, entitled “Deployment techniques for annuloplasty ring and over-wire rotation tool,” to Zipory et al., filed May 4, 2010 and issued as WO 10 / 128503;

[0592] U.S. Patent Application Publication No. 2014 / 0309661 to Sheps et al.; and / or

[0593] US Patent Application Publication No. 2015 / 0272734 to Sheps et al.

[0594] All of these applications are incorporated herein by reference. The technology described herein can be practiced in conjunction with the technology described in one or more of these applications. In addition, any and all of the methods, techniques, steps, etc. described herein can be performed on live animals or in simulation / simulation methods (e.g., in corpses, corpse hearts, simulators with simulated hearts, tissues, etc., anthropomorphic mannequins, etc.).

[0595] The present invention is not limited to what has been specifically shown and described above. On the contrary, the scope of the present invention includes both the combination and sub-combination of the various features described above, as well as variations and modifications of the combinations and sub-combinations that are not within the scope of the prior art, which should be expected by those skilled in the art when reading the above description.

Claims

1. A device comprising: An implantable annuloplasty structure, the implantable annuloplasty structure comprising: The main part; and a contraction member having (1) a first portion extending along a longitudinal length of the main portion of the annuloplasty structure, and (2) a second portion extending away from the main portion of the annuloplasty structure; and A shrinking member receiving tool, the shrinking member receiving tool comprising: a main tube terminating at a distal end portion of the retraction member receiving tool, the distal end portion of the retraction member receiving tool having a distal tip; a secondary tube disposed side by side with the primary tube, the secondary tube having a secondary tube lumen configured to allow the contraction member to pass therethrough; and a contraction member snare comprising a distal snare portion and an elongated flexible body portion coupled to the distal snare portion, the distal snare portion being configured to snare a portion of the contraction member and sized to pass through the secondary tube lumen of the secondary tube so as to pull the second portion of the contraction member through a length of the secondary tube, Wherein the snare portion comprises a flexible ring, and the secondary tube lumen of the secondary tube is sized to maintain the coupling between the distal snare portion and the contraction member by collapsing the ring around the contraction member when the elongated flexible body portion is pulled through the secondary tube lumen.

2. The apparatus of claim 1, wherein the distal snare portion is configured to pull the second portion of the constriction member through the distal tip of the constriction member receiving tool and subsequently through the length of the secondary tube.

3. The device of any one of claims 1 to 2, wherein the retraction member snare comprises a wire having a diameter of 0.2 mm to 0.25 mm.

4. The apparatus according to any one of claims 1 to 2, wherein the main pipe is flexible, and wherein the secondary pipe is flexible.

5. The apparatus according to any one of claims 1 to 2, wherein the annuloplasty structure defines a partial annuloplasty ring structure.

6. The apparatus according to any one of claims 1 to 2, wherein the secondary tube is shaped to define a longitudinal slit.

7. The apparatus of any one of claims 1 to 2, wherein the retraction member receiving tool comprises a handle portion, and wherein the first tube and the second tube are connected to the handle portion.

8. The apparatus of claim 7, wherein the handle portion comprises: a contraction member receiving device configured to receive a continuous portion of the contraction member; as well as A tension meter is configured to measure the degree of tension of the contraction member.

9. Apparatus according to claim 8, wherein the retraction member receiving means is actuatable to increase tension in the retraction member.

10. The apparatus of claim 8, wherein the retraction member receiving device comprises a knob coupled to a proximal portion of the retraction member, the knob being configured to increase tension in the retraction member by pulling the retraction member proximally.

11. The apparatus of claim 10, wherein the retraction member receiving device comprises a wheel having a groove configured to couple the retraction member to the wheel.

12. The apparatus of claim 11, wherein the groove is shaped to receive a middle portion of the constriction member.

13. The device of 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 apparatus of 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 constriction member through the entire length of the secondary tube.

15. The apparatus according to any one of claims 1 to 2 and 8 to 12, wherein the retraction member receiving means comprises: at least one retraction member fastener disposed within the distal end portion of the retraction member receiving tool, the retraction member fastener comprising a clamping structure that is (a) biased toward assuming a closed condition in which the clamping structure is configured to clamp onto the retraction member passing therethrough, and (b) capable of being deflected to an open condition through which the retraction member can move; as well as A stopper is removably coupled to the retracting member fastener and is configured to retain the retracting member fastener in the open state.

16. The apparatus of claim 15, wherein the at least one retraction member fastener comprises at least a first retraction member fastener and a second retraction member fastener, the first retraction member fastener and the second retraction member fastener being disposed within the distal end portion of the retraction member receiving tool.

17. The apparatus of claim 16, wherein the distal snare portion and the elongated flexible body portion of the retraction member snare are sized to pass distally through the retraction member fastener in the open state, the snare portion being adapted to capture the retraction member and pull the retraction member proximally through the retraction member fastener and through an alignment port in the distal end portion of the retraction member receiving tool.

18. The apparatus of claim 17, wherein the contraction member receiving tool comprises a fastener-ejector movable within the distal end portion of the contraction member receiving tool, and wherein movement of the fastener-ejector contacts the contraction member fastener and transitions the contraction member fastener from the open state to the closed state to clamp onto the contraction member passing therethrough.

19. The apparatus of claim 18, wherein the fastener-ejector is coupled to the stopper and moves the stopper removably coupled to the fastener.

20. An apparatus according to any one of claims 18 to 19, wherein the distal end portion of the retraction member receiving tool is formed to define a sharp edge, and wherein the retraction member is arranged adjacent to the sharp edge so that movement of the fastener-ejector against the sharp edge severs the retraction member extending through the fastener.

21. The apparatus of any one of claims 1 to 2, 8 to 12, and 16 to 19, further comprising: at least one retraction member fastener configured to surround the retraction member, the retraction member fastener comprising a clamping structure that is (a) biased toward assuming a closed state in which the clamping structure is configured to clamp onto the retraction member passing therethrough, and (b) capable of being deflected to an open state through which the retraction member can move; as well as A stopper is removably coupled to the retracting member fastener and is configured to retain the retracting member fastener in the open state.

22. The apparatus of claim 21 , wherein the tool comprises a movable cutting element having a sharp edge, and movement of the stop hammers the stop against the movable cutting element such that movement of the movable cutting element severs the contraction member extending through the fastener and through the movable cutting element.

23. The apparatus of any one of claims 1 to 2, 8 to 12, 16 to 19 and 22, further comprising: a lock slidable along the retraction member, the lock being fixedly coupled to the retraction member to prevent movement of the retraction member, wherein: The lock is shaped to define a slot extending from a proximal surface of the lock toward a distal surface of the lock, The lock defines a lock cavity of the lock extending from a proximal opening in the lock toward a distal opening in the lock, The lock cavity is configured to surround the retraction member, and When the lock is compressed, the slit enables the lock to close around the retraction member and thereby lock the lock to the retraction member.

24. The apparatus of claim 23, wherein the annuloplasty structure is shaped to define a recess sized to compress the lock when the lock is at least partially disposed within the recess.

25. The apparatus of claim 24, wherein the recess is sized to compress the lock when the lock is at least partially disposed within the recess.

26. The apparatus of claim 23, wherein the locking cavity is shaped to define a distal portion that is wider than a proximal portion of the locking cavity.

27. The apparatus of claim 26, wherein the recess is shaped to define a proximal portion that is narrower than any other portion of the recess distal to the proximal portion.

28. The apparatus of claim 23, wherein the lock is disposed within the distal end portion of the retraction member receiving tool.

29. The apparatus of claim 28, wherein the lock is at least partially disposed within the recess when the retraction member containment tool is coupled to the annuloplasty structure.

30. The apparatus of claim 28, wherein the lock is disposed entirely proximal to the recess when the retraction member receiving tool is coupled to the annuloplasty structure.

31. The apparatus of claim 23, wherein the lock is disposed within the distal end portion of the retraction member receiving tool.

32. The apparatus of claim 31 , wherein the distal snare portion and the elongated flexible body portion of the retraction member snare are sized to pass distally through a lock, the snare portion being adapted to capture the retraction member and pull the retraction member proximally through the lock and through an alignment port in the distal end portion of the retraction member receiving tool.

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