Valvuloplasty techniques

Abstract

The invention is entitled "valvuloplasty technique". The invention provides an apparatus comprising an implant, the implant comprising a valvuloplasty structure (222, 611, 631, 641, 651, 711) having a basic body portion (750), a contraction member (226) extending along a contraction portion of the valvuloplasty structure (222, 611, 631, 641, 651, 711), an actuatable adjustment mechanism (40) coupled to the contraction member and adjusting the length of the valvuloplasty structure (222, 611, 631, 641, 651, 711) by applying tension to the contraction member (226) when actuated, and a contraction member protection element (633) having a first end coupled to the basic body portion (750) of the valvuloplasty structure (222, 611, 631, 641, 651, 711) and a second end coupled to the adjustment mechanism (40). The retraction member (226) extends from the adjustment mechanism (40) via the retraction member protection element (633) to the basic body portion (750) of the annuloplasty structure (222, 611, 631, 641, 651, 711). Other applications are also described.

Description

[0001] This application is a divisional application. The application date of the original application is April 21, 2016, the application number is 201680038260.5 (the application number of the divisional application is 202010127508.3), and the name of the invention is “Valvuloplasty Technology”.

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS

[0003] This application claims priority to US Provisional Patent Application No. 62 / 154,962 to Reich et al., entitled “Annuloplasty technologies,” filed on April 30, 2015, which is incorporated herein by reference. Technical Field

[0004] The present invention relates generally to valve repair, and more particularly to the repair of an atrioventricular valve in a subject. Background of the Invention

[0005] Ischemic heart disease causes mitral regurgitation through a combination of ischemic dysfunction of the papillary muscles and left ventricular dilatation present in ischemic heart disease, with subsequent papillary muscle displacement and mitral annular dilatation.

[0006] Dilation of the mitral annulus prevents the leaflets from fully coapting when the valve closes. Mitral regurgitation of blood from the left ventricle to the left atrium results in an increased total stroke volume and decreased cardiac output, with eventual weakening of the left ventricle secondary to left atrial volume and pressure overload. Summary of the invention

[0007] In some applications of the present invention, a multi-component tubular system for accessing a subject's heart is provided. The system includes one or more steerable guide catheters configured to guide a device through which it enters the heart. The multi-component tubular system is configured to deliver an implant to the subject's heart valve annulus in a desired orientation and facilitate anchoring of the implant to the annulus. For some applications of the present invention, the guide system is advanced transcavitary or transthoracic to access the atrium of the heart. Generally, the system includes two or more steerable catheters. The first catheter has a distal portion that is steerable to a first desired spatial orientation. The second catheter is disposed within the first catheter and has a distal portion that is steerable to a second desired spatial orientation. The system provides 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 twisting the first spatial orientation of the distal portion of the first catheter.

[0008] For some applications, the implant is advanced through a multi-component catheter system and anchored to the tissue of the subject by driving one or more tissue anchors through a passage using an anchor driver. For some applications, the anchor driver is used to provide a reference force to the most recently anchored anchor as the implant is further exposed from the catheter system. For some applications, a first tissue anchor has a tissue coupling element that is wider than the tissue coupling element of a subsequent anchor and wider than the passage. For some applications, a spear is used to control the anchoring of the tissue anchor.

[0009] For some applications, the implant has a retraction member that extends from the adjustment mechanism along the implant and back again.

[0010] For some applications, a system for repeatedly docking and adjusting an adjustment mechanism of an implant is provided.

[0011] For some applications, the multi-component catheter system includes a dynamometer for testing the anchoring strength of individual anchors after they have been anchored.

[0012] Implementation methods thereof are also described.

[0013] Therefore, according to an application of the present invention, there is provided a device for subject tissue, the device comprising:

[0014] An anchor, the anchor comprising:

[0015] Anchor head, and

[0016] a tissue engaging member coupled to the anchor head, extending distally away from the anchor head to a distal tip of the tissue engaging member, and configured to anchor the anchor to tissue;

[0017] An anchor driver, the anchor driver comprising:

[0018] a longitudinal axis having a flexible distal portion and a distal end,

[0019] a deployment element at the distal end of the shaft, reversibly lockable to the anchor head and reversibly movable between: (i) a locked state in which the deployment element and the anchor head are locked, and (ii) an unlocked state in which the deployment element is unlocked from the anchor head, and

[0020] A tissue piercing spear that can be reversibly moved between the following states:

[0021] an extended state, wherein (i) the lance extends distally from the axial direction, (ii) the lance extends distally beyond the distal tip of the anchor when the deployment element is locked to the anchor head, and (iii) the lance retains the deployment element in the locked state, and

[0022] A retracted state, in which the deployment element automatically moves to an unlocked state.

[0023] In use, in the retracted state, the lance does not extend distally beyond the distal tip of the anchor.

[0024] In use, in the retracted state, the lance does not extend distally from the axis.

[0025] According to the application of the present invention, there is further provided a device for object tissue, the device comprising:

[0026] Percutaneous catheters;

[0027] an implant sized to be advanced into a subject via a catheter;

[0028] an anchor delivery channel shaped to define a lumen therethrough, the lumen having a diameter, and the channel being sized to be deployable within the catheter;

[0029] at least one anchor including an anchor head coupled to the tissue coupling element, the anchor head defining a hole therethrough, and

[0030] Anchor Driver:

[0031] The invention comprises a trunk, and a driving head coupled to a distal end of the trunk, the driving head being reversibly coupled to an anchor head, and configured to advance an anchor through a lumen of a channel when the driving head is coupled to the anchor head.

[0032] further comprising a lance that is reversibly extendable relative to the driver head such that when the driver head is coupled to the anchor head, extension of the lance causes the lance to slide through the aperture such that a tip of the lance is disposed distally past a distal tip of the tissue engaging element, and

[0033] The invention is configured to drive the tip of the spear through a portion of the implant and into tissue of the subject, and to drive the tissue coupling element of the anchor through a portion of the implant and into tissue of the subject - independently of the driving of the spear tip.

[0034] According to the application of the present invention, there is further provided a device for object tissue, the device comprising:

[0035] Anchorage, comprising:

[0036] an anchor head having a proximal side and a distal side and defining a hole from the proximal side to the distal side,

[0037] a tissue engaging member coupled to the anchor head, extending distally away from the anchor head to a distal tip of the tissue engaging member, and configured to anchor the anchor to tissue;

[0038] Anchor driver, comprising:

[0039] a longitudinal axis having a flexible distal portion and a distal end,

[0040] A tissue piercing spear, reversibly extendable from the axial distal end,

[0041] a deployment element coupled to the distal end of the shaft and reversibly coupleable to the anchor head at a location where distal extension of the lance from the shaft moves the lance through the aperture and past the distal tip of the anchor; and

[0042] Catheter system, comprising:

[0043] catheter:

[0044] The anchor driver may be advanced in vivo through the catheter (i) with the deployment element coupled to the anchor head, and (ii) with the distal portion of the shaft extending distally out of the catheter, and

[0045] having a distal section that is deflectable within the body relative to another section of the catheter immediately proximal to the distal section, and

[0046] an extracorporeal controller configured to cause the distal segment to deflect relative to the further segment when the distal portion of the shaft extends distally out of the catheter and the spear extends distally from the shaft and is disposed in tissue, such that the distal portion of the shaft deflects relative to the further portion of the shaft immediately proximal to the distal portion,

[0047] The anchor driver is configured to drive the tissue engaging member into tissue when the distal portion of the shaft is deflected relative to another portion of the shaft.

[0048] According to the application of the present invention, a method is further provided, comprising:

[0049] advancing a distal end of an anchor driver through the catheter and toward tissue of a subject, the anchor driver comprising a shaft, a tissue piercing lance, and a deployment element;

[0050] Subsequently, the tissue is pierced with a spear;

[0051] deflecting a distal portion of the shaft relative to another portion of the shaft proximally adjacent to the distal portion by moving a distal section of the catheter while at least some of the lances are disposed within the tissue; and

[0052] The tissue engaging member of the anchor is driven into tissue using the anchor driver while (i) the distal portion of the shaft is deflected relative to the other portion of the shaft and (ii) the deployment element is locked to the anchor head.

[0053] According to the application of the present invention, a method for implantation is further provided, the method comprising:

[0054] advancing the implant through the catheter percutaneously toward an implantation site in the subject using an implant manipulation handle coupled to the implant;

[0055] Sliding the implant relative to the catheter by applying a first force to the implant handle without causing the implant to apply force to tissue at the implantation site;

[0056] measuring a magnitude of a first force;

[0057] Subsequently, anchoring the implant to the tissue at the implantation site;

[0058] Subsequently, applying a second force to the implant handle causes the implant to apply a third force to the tissue at the implant site via the implant anchor;

[0059] measuring a magnitude of a second force; and

[0060] A magnitude of the third force is determined in response at least in part to a difference between the first force magnitude and the second force magnitude.

[0061] In use, sliding the implant by applying the first force to the implant handling handle includes sliding the implant proximally relative to the catheter by applying the first force to the implant handling handle.

[0062] In the application:

[0063] Measuring the magnitude of the first force includes measuring the magnitude of the first force using a dynamometer,

[0064] Measuring the magnitude of the second force includes measuring the magnitude of the second force using a force gauge, and

[0065] The method further includes, after measuring the magnitude of the first force and before causing the implant to apply a third force, zeroing the force gauge to the magnitude of the first force.

[0066] In the application:

[0067] The anchor handle includes a dynamometer,

[0068] Measuring the magnitude of the first force includes measuring the magnitude of the first force using a dynamometer, and

[0069] Measuring the magnitude of the second force includes measuring the magnitude of the second force using a force gauge.

[0070] In use, anchoring the implant includes anchoring the implant by driving a tissue anchor into tissue at the implantation site.

[0071] In use, causing the implant to apply the third force by applying the second force to the implant handle includes causing the implant to apply the third force via the tissue anchor by applying the second force to the implant handle.

[0072] According to the application of the present invention, there is further provided a device, comprising:

[0073] Percutaneously insertable implants;

[0074] The regulating device comprises:

[0075] an adjustment mechanism coupled to the implant and configured to change a size of the implant upon actuation of the adjustment mechanism; and

[0076] Lock:

[0077] having a locked state in which the lock inhibits actuation of the adjusting mechanism,

[0078] has an unlocked state in which the adjustment mechanism is actuatable, and

[0079] can be reversibly moved between a locked state and an unlocked state;

[0080] longitudinal guide members; and

[0081] Connectors:

[0082] coupled to the guide member,

[0083] comprising a fastener coupling the connector to the adjusting device and being decoupleable from the adjusting device in vivo,

[0084] is configured to be delivered percutaneously when coupled to the regulating device, and

[0085] An unlocking mechanism is included and is configured such that, when the joint is coupled to the adjustment device, actuation of the unlocking mechanism moves the lock between the locked state and the unlocked state.

[0086] In use, actuation of the unlocking mechanism, by pressing the unlocking mechanism on a depressible portion of the lock, moves the lock from the locked state to the unlocked state.

[0087] In use, the unlocking mechanism includes a pin disposed in the channel, and actuation of the unlocking mechanism to move the lock from the locked state to the unlocked state includes sliding of the pin within the channel.

[0088] In use, the fastener is shaped to define at least a portion of the passageway.

[0089] In the application:

[0090] The adjustment device is shaped to define a first thread, and

[0091] The fastener is (i) shaped to define a second thread that allows the fastener to be coupled to the adjustment device by engaging the first thread, and (ii) can be disconnected from the adjustment device in vivo by the second thread being unthreaded from the first thread.

[0092] In use, the lock is biased in a locked state in the absence of depression of the depressible portion.

[0093] In use, the device further comprises an adjustment tool, and the adjustment tool:

[0094] After implantation, the implant can be pushed percutaneously along the guide member to the joint.

[0095] including an adjustment mechanism interface sized to interface with the adjustment mechanism,

[0096] The invention comprises a joint interface sized to interface with the joint and comprising a force applying device and configured to:

[0097] moving the lock to the unlocked state by actuating the unlocking mechanism by applying a force to the unlocking mechanism with a force applying device when the joint is coupled to the adjusting device, and

[0098] The adjusting mechanism is actuated via the connection between the adjusting mechanism interface and the adjusting mechanism.

[0099] In use, the tool is configured to decouple the head from the adjustment device.

[0100] In application, the adjustment mechanism interface and the joint interface are independently controllable.

[0101] In use, the tool is configured to decouple the head from the adjustment device independently of actuating the unlocking mechanism.

[0102] In use, the force applying device is axially slidable relative to the joint and is configured to actuate the unlocking mechanism by applying an axial force to the unlocking mechanism.

[0103] In the application:

[0104] The connector includes a body shaped to define a passageway,

[0105] The unlocking mechanism includes a channel, and a pin slidably disposed in the channel, and

[0106] The force applying device is configured to actuate the unlocking mechanism by applying an axial force to the pin to slide the pin within the channel.

[0107] In use, the body is shaped to define a side opening, the pin includes an appendage projecting laterally from the opening, and the joint interface is dimensioned to be slidable over the proximal portion of the body to an extent sufficient to allow the force applying device to reach the appendage.

[0108] In use, the cross-section of the proximal portion of the body has a non-circular outer shape, and the tool is configured to decouple the head from the adjustment device by applying torque to the body through the head interface.

[0109] In use, the distal portion of the joint interface is angled such that in response to axial sliding of the joint interface over the proximal portion of the body, the joint interface automatically assumes a predetermined rotational orientation relative to the body.

[0110] In use, the distal portion of the joint interface is angled so that in a predetermined rotational orientation, the force applying device is aligned with the accessory.

[0111] In use, the force applying device is angled such that in response to axial sliding of the joint interface on the proximal portion of the body, the joint interface automatically assumes a predetermined rotational orientation relative to the body.

[0112] In use, the distal portion of the joint interface is angled so that in a predetermined rotational orientation, the force applying device is aligned with the accessory.

[0113] In use, when the joint interface assumes a predetermined rotational orientation in which the force applying device is aligned with the attachment, the non-circular shape of the proximal portion of the body inhibits further rotation of the joint interface in response to further axial sliding of the joint interface on the body.

[0114] In use, the body is shaped to define one or more shoulders that are angled such that the joint interface automatically assumes a predetermined rotational orientation relative to the body in response to axial sliding of the joint interface over the shoulders.

[0115] In use, the distal portion of the joint interface is angled so that in a predetermined rotational orientation, the force applying device is aligned with the accessory.

[0116] According to the application of the present invention, there is further provided a device for use with a subject's tissue, the device comprising a valvuloplasty structure, the valvuloplasty structure comprising:

[0117] a sleeve having a first end and a second end, a bearing site, and including a sidewall defining a cavity from the first end to the second end,

[0118] regulating mechanism, and

[0119] Contraction components:

[0120] having a first end coupled to an adjustment mechanism,

[0121] A first portion having a self-adjusting mechanism extending along the sleeve toward the second end to the bearing location, and

[0122] having a second portion extending from the bearing location back toward the adjustment mechanism and the first end,

[0123] The adjustment mechanism is configured to pull on the first portion of the retraction member so that the second portion of the retraction member progressively slides past the bearing site to reduce the length of the sleeve between the first end and the second end.

[0124] In use, the first portion is interwoven through the side wall of the sleeve.

[0125] In use, the second portion is interwoven through the side wall of the sleeve.

[0126] In use, the first portion passes along the cavity.

[0127] In use, the second portion is passed along the cavity.

[0128] In use, the retraction member has a second end that is flexibly coupled to the sleeve.

[0129] In use, the sleeve has a cavity therein, which defines a bearing site, and through which the retraction member can slide.

[0130] According to the application of the present invention, a method is further provided, comprising:

[0131] percutaneously advancing an implant including a sleeve defining a tubular sidewall and a lumen toward tissue of the subject with the distal portion of the anchor delivery channel disposed within the lumen such that a distal opening of the channel is disposed at the first portion of the sleeve;

[0132] anchoring the first portion of the sleeve to the first tissue site - by driving the tissue coupling element of the first anchor through the distal opening of the passage, through the sidewall of the first portion of the sleeve, and into the first tissue site using an anchor driver;

[0133] pressing a second portion of the sleeve against a second tissue site; and

[0134] Anchoring the second portion of the sleeve to the second tissue site by driving the tissue coupling element of the second anchor from outside the lumen through the opposite side of the sidewall of the second portion of the sleeve and into the second tissue site.

[0135] In use, pressing the second portion of the sleeve against the second tissue site includes pressing the second portion of the sleeve against the second tissue site such that opposing sides of sidewalls of the second portion of the sleeve contact each other.

[0136] In the application:

[0137] The implant comprises a valvuloplasty structure, the valvuloplasty structure comprising a sleeve,

[0138] Anchoring the first portion of the sleeve to the first tissue site includes anchoring the first portion of the sleeve to an annulus of an atrioventricular valve of the subject's heart, and

[0139] Anchoring the second portion of the sleeve to the second tissue site includes anchoring the second portion of the sleeve to a wall of an atrial cavity of the subject's heart.

[0140] According to the application of the present invention, a method is further provided, the method comprising:

[0141] percutaneously advancing an implant including the sleeve toward tissue of a subject with the distal portion of the anchor delivery channel disposed within the lumen defined by the sleeve such that the distal opening of the channel is disposed at the first portion of the sleeve;

[0142] anchoring the first portion of the sleeve to the tissue by driving, with an anchor driver, a tissue coupling element of the first anchor through the distal opening of the passage, through the sleeve, and into the tissue;

[0143] subsequently, while providing a distally directed reference force to the first anchor by the driver, proximally withdrawing the distal portion of the channel such that the distal opening of the channel is disposed at the second portion of the sleeve;

[0144] Thereafter, withdrawing the driver proximally through the passage; and

[0145] The second portion of the sleeve is then anchored to the tissue by driving the tissue coupling element of the second anchor through the distal opening of the passage, through the sleeve, and into the tissue.

[0146] According to the application of the present invention, there is further provided a device for object tissue, the device comprising:

[0147] Percutaneous catheters;

[0148] an implant sized to be advanced into a subject via a catheter;

[0149] an anchor delivery channel shaped to define a lumen therethrough, the lumen having a diameter, and the channel being sized to be deployable within the catheter;

[0150] at least one small anchor including a small anchor head coupled to the small anchor tissue coupling element and having a central longitudinal axis from the small anchor head to the small anchor tissue coupling element, the maximum transverse width of the small anchor being less than the diameter of the passage lumen;

[0151] at least one macro-anchor comprising a macro-anchor head coupled to the macro-anchor tissue coupling element and having a central longitudinal axis from the macro-anchor head to the macro-anchor tissue coupling element, the macro-anchor having a maximum transverse width greater than a diameter of the passageway lumen; and

[0152] An anchor driver includes a driver head reversibly couplable to the large anchor anchor head, and a trunk sized to extend from the driver head through the channel lumen to outside the proximal end of the channel when the driver head is coupled to the large anchor anchor head.

[0153] In the application:

[0154] The large anchor is arranged at the distal portion of the channel, and at least the large anchor tissue coupling element is outside the channel lumen,

[0155] The drive head is connected to the anchor head of the large anchor.

[0156] The main trunk extends from the driving head to the proximal side through the channel cavity and extends to the outside of the proximal end of the channel.

[0157] The implant is shaped to define a cavity,

[0158] The distal channel and large anchor tissue coupling element are disposed within the lumen of the implant and are slidable with the implant through the catheter while within the lumen of the implant.

[0159] In application, the diameter of the channel cavity is 2-3 mm.

[0160] In use, the maximum lateral width of the large anchor is 3-4 mm.

[0161] In use, the large anchor tissue engaging element is shaped to define a helix having a transverse width of 3-4 mm.

[0162] In use, the large anchor head has a maximum transverse width of 2-3 mm.

[0163] In use, the small anchor tissue engaging element is shaped to define a helix having a transverse width of 2-3 mm.

[0164] In use, the maximum lateral width of the large anchor is the maximum lateral width of the large anchor tissue coupling element.

[0165] In use, the maximum transverse width of the anchor head of the large anchor is smaller than the diameter of the passage cavity.

[0166] In use, the maximum transverse width of the anchor head of the large anchor is greater than the diameter of the passage cavity.

[0167] According to some applications of the present invention, an implant is further provided, the implant having a main body portion, the implant comprising:

[0168] contraction member;

[0169] an actuatable adjustment mechanism coupled to the contraction member and configured to adjust the size of the body portion of the implant by applying tension to the contraction member when actuated; and

[0170] An adjustment indicator is coupled to the contraction member and directly to the body portion of the implant and is configured to change shape based on the degree of tension of the contraction member.

[0171] In some applications of the present invention, the implant includes an annuloplasty ring structure.

[0172] In some applications of the present invention, the body portion includes a sleeve.

[0173] In some applications of the present invention, the adjustment indicator is directly coupled to an outer surface of the main body portion of the implant.

[0174] In some applications of the present invention, the adjustment indicator includes a radiopaque element.

[0175] In some applications of the present invention, the implant includes an annuloplasty structure, and the retraction member is coupled to the annuloplasty structure via a radiopaque element.

[0176] In some applications of the present invention:

[0177] Radiopaque elements include:

[0178] Container; and

[0179] a stopper shaped to fit within the container,

[0180] The constriction member is coupled to the radiopaque element by coupling to the plug such that an increase in the degree of tension of the constriction member causes a change in the shape of the radiopaque element by positioning the plug within the container.

[0181] In some applications of the present invention, a radiopaque element is disposed adjacent to the adjustment mechanism.

[0182] In some applications of the present invention, the adjustment mechanism is coupled to the retraction member at a first end of the retraction member, and the radiopaque element is coupled to the retraction member at a second end of the retraction member.

[0183] In some applications of the present invention, the retraction member is threaded through the radiopaque element.

[0184] In some applications of the present invention, the implant includes an annuloplasty structure, and the radiopaque element is coupled to the contraction member such that an increase in the degree of tension of the contraction member changes the shape of the radiopaque element by pressing the radiopaque element against the annuloplasty structure.

[0185] In some applications of the present invention, the radiopaque element comprises a belt.

[0186] In some applications of the present invention, the tape has a width of 1-3 mm.

[0187] In some applications of the present invention:

[0188] The shape of the belt in an unstressed state when no tension is applied to the contraction member has an unstressed longitudinal length measured along the longitudinal axis of the belt of 4-6 mm, and

[0189] In response to an increase in the degree of tension of the contraction member, at least a portion of the band is compressed toward the implant, assumes a compressed state, and has a compressed longitudinal length of 7-10 mm measured along the longitudinal axis of the band.

[0190] In some applications of the present invention, the radiopaque element includes a tube surrounding a portion of the retraction member.

[0191] In some applications of the present invention, the radiopaque element is coupled to the contraction member such that an increase in the degree of tension of the contraction member causes the shape of the radiopaque element to change by compressing the tube.

[0192] In some applications of the present invention, the radiopaque element includes a spring.

[0193] In some applications of the present invention, the radiopaque element is coupled to the retraction member such that an increase in the degree of tension of the retraction member causes the shape of the radiopaque element to change by expanding the spring.

[0194] In some applications of the present invention, the spring comprises a truncated cone scroll spring.

[0195] In some applications of the present invention, the spring includes a telescoping spring surrounding a portion of the retractable member.

[0196] In some applications of the present invention, the radiopaque element is coupled to the retraction member such that an increase in the degree of tension of the retraction member causes the shape of the radiopaque element to change by compressing the spring.

[0197] In some applications of the present invention:

[0198] The radiopaque element is shaped to define at least first and second arms, and

[0199] The contraction member is coupled to the radiopaque element by coupling to each of the first and second arms such that an increase in the degree of tension of the contraction member changes the shape of the radiopaque element by changing the distance between the first and second arms.

[0200] In some applications of the present invention, the first and second arms are drawn toward each other in response to an increase in the degree of tension in the retraction member.

[0201] In some applications of the present invention, the retraction member passes through corresponding portions of the first and second arms.

[0202] According to some applications of the present invention, an implant is further provided, the implant comprising:

[0203] A valvuloplasty structure having a primary body portion;

[0204] a constriction member extending along at least a constriction portion of the annuloplasty structure;

[0205] an actuatable adjustment mechanism coupled to the contraction member and configured to adjust the length of the annuloplasty structure by applying tension to the contraction member when actuated; and

[0206] a contraction member protection element having a first end coupled to the base body portion of the annuloplasty structure and a second end coupled to the adjustment mechanism,

[0207] The retraction member extends from the adjustment mechanism via the retraction member protection element to a substantial body portion of the annuloplasty structure.

[0208] In some applications of the present invention, the first end of the retraction member protection element is connected to the annuloplasty structure at a connection point that is at least 10 mm from either end of the annuloplasty structure.

[0209] In some applications of the present invention, the annuloplasty structure includes a first sleeve including a tubular sidewall defining a first lumen therethrough, the contraction member protection element includes a second sleeve defining a second lumen therethrough, and a portion of the contraction member is disposed within the second lumen.

[0210] In some applications of the present invention, the retraction member protection element includes a belt, and the retraction member passes through the belt.

[0211] In some applications of the present invention, the tape has a width of 3-5 mm.

[0212] In some applications of the present invention, the band width is 10 times greater than the width of the constricting member.

[0213] In some applications of the present invention, the retraction member protection element includes a spring, and the retraction member is disposed within a cavity of the spring.

[0214] In some applications of the present invention:

[0215] The first end of the retraction member protection element is connected to the annuloplasty structure at a connection point,

[0216] The annuloplasty structure defines a central longitudinal axis,

[0217] The implant has a delivery state in which:

[0218] The implant can be advanced percutaneously through a catheter to the implantation site, and

[0219] The adjustment mechanism is arranged on the central longitudinal axis, distal to the annuloplasty structure, and the retraction member protection element extends from the connection point alongside the annuloplasty structure to the adjustment mechanism,

[0220] The implant has a deployed state, where:

[0221] The adjustment mechanism is arranged laterally of the central longitudinal axis, and

[0222] Tensioning of the retraction member by the adjustment mechanism moves the adjustment mechanism closer to the connection point and compresses the retraction member protection element.

[0223] In some applications of the present invention, the retraction member protection element has a longitudinal length of 10-15 mm before tensioning the retraction member, as measured along a central longitudinal axis of the retraction member protection element.

[0224] In some applications of the present invention, the device further comprises a plurality of tissue anchors:

[0225] The annuloplasty structure has a distal end, and a distal portion extending between the connection point and the distal end,

[0226] The plurality of tissue anchors includes (i) at least three tissue anchors disposed at a distal portion of the annuloplasty structure, and (ii) at least one tissue anchor disposed at a constriction portion of the annuloplasty structure.

[0227] According to some applications of the present invention, there is further provided a device comprising an implant, the implant comprising:

[0228] A valvuloplasty structure comprising a first sleeve including a tubular sidewall defining a first lumen therethrough;

[0229] a retraction member having a first portion extending along at least a retraction portion of the first sleeve of the valvuloplasty structure, the retraction member exiting the first lumen at an exit point of the first lumen;

[0230] an actuatable adjustment mechanism coupled to the contraction member at an end of the contraction member and configured to adjust the length of the annuloplasty structure by applying tension to the contraction member when actuated; and

[0231] A second sleeve coupled to the first sleeve at an exit point of the constriction member from the first chamber, the second sleeve:

[0232] defining a second lumen through the second sleeve, the second portion of the retraction member being disposed within the second lumen and extending to the adjustment mechanism, and

[0233] An adjustment mechanism is coupled to the first sleeve.

[0234] According to some applications of the present invention, there is further provided a device for an object, the device comprising:

[0235] a catheter advanceable transluminally into a subject; and

[0236] An implant advanceable through a catheter includes a flexible sleeve defining a lumen having a proximal end, a distal end and a central longitudinal axis therebetween, the implant twisting about the sleeve longitudinal axis and being longitudinally slidable through the catheter when the sleeve is twisted about the sleeve longitudinal axis.

[0237] In some applications of the present invention, the twist angle between the proximal and distal ends of the sleeve is 170-190 degrees.

[0238] In some applications of the present invention, the device further includes a channel that can slide longitudinally through the catheter, and the flexible sleeve of the implant covers the distal portion of the channel when the sleeve is twisted about the sleeve axis, and when the sleeve covers the distal portion of the channel when the sleeve is twisted about the sleeve axis, the implant can slide longitudinally through the catheter along the channel.

[0239] In some applications of the present invention, the apparatus further comprises:

[0240] a retraction member extending longitudinally of the sleeve; and

[0241] An actuatable adjustment mechanism is coupled to the contraction member and is configured to adjust the size of the implant by applying tension to the contraction member when actuated.

[0242] In some applications of the present invention, the contraction member has a first end connected to the adjustment mechanism and a second end connected to the implant sleeve, and when the sleeve is twisted about the sleeve axis, the adjustment mechanism twists from the second end of the contraction member at a twisting angle between 155 and 175 degrees.

[0243] In some applications of the present invention, the device further includes a channel that can slide longitudinally through the catheter, and the flexible sleeve of the implant covers the distal portion of the channel when it is twisted about the sleeve axis, and the implant can slide longitudinally through the catheter along the channel when the sleeve covers the distal portion of the channel when it is twisted about the sleeve axis.

[0244] In some applications of the present invention, the implant is rotated about the central longitudinal axis of the passage as the sleeve encompasses the distal portion of the passage while twisting about the sleeve axis.

[0245] In some applications of the present invention, the retraction member has a first end coupled to the adjustment mechanism and a second end coupled to a portion of the implant sleeve, and the retraction member defines:

[0246] a first longitudinal portion extending from the adjustment mechanism along a first longitudinal path,

[0247] a second longitudinal portion extending to the portion of the implant sleeve along a second longitudinal path offset relative to the first longitudinal path, and

[0248] An offset portion offsets the first and second longitudinal portions of the retraction member.

[0249] In some applications of the present invention, the offset portion extends along a stepped path.

[0250] In some applications of the present invention, the offset portion extends along a helical path.

[0251] In some applications of the present invention, the sleeve of the implant is tubular, and the offset distance between the first and second longitudinal portions is 0.3-0.7 radians.

[0252] In some applications of the present invention, the first and second longitudinal portions are offset by a distance of 0.8-1.2 mm.

[0253] According to some applications of the present invention, there is further provided a device comprising an implant, the implant comprising:

[0254] An annuloplasty structure having a main body portion;

[0255] a constriction member extending along at least a constriction portion of the annuloplasty structure; and

[0256] an actuatable adjustment mechanism coupled to the contraction member and configured to adjust the length of the annuloplasty structure by applying tension to the contraction member when actuated,

[0257] A retraction member having a first end coupled to the adjustment mechanism and a second end coupled to a portion of the body portion of the implant, the retraction member defining:

[0258] a first longitudinal portion extending from the adjustment mechanism along a first longitudinal path,

[0259] a second longitudinal portion extending to the portion of the implant sleeve along a second longitudinal path offset relative to the first longitudinal path, and

[0260] An offset portion offsets the first and second longitudinal portions of the retraction member.

[0261] According to some applications of the present invention, there is further provided a device for an object, the device comprising:

[0262] a flexible sleeve that is advanceable through the lumen into a subject and includes a tubular sidewall that (i) defines a central longitudinal axis of the sleeve and (ii) defines a lumen having a distal end, a proximal end, and a length therebetween; and

[0263] Longitudinal contraction member:

[0264] coupled to the flexible sleeve so that tensioning the contraction member reduces the length of the lumen, and

[0265] Coupled to the sidewall such that in the absence of twisting of the sleeve about the longitudinal axis, at least a portion of the constriction member is helically arranged about the longitudinal axis.

[0266] In some applications of the present invention, the retraction members are interwoven through the side walls.

[0267] In some applications of the present invention, the constriction member extends along at least the constriction portion of the sleeve.

[0268] In some applications of the present invention, the retraction member extends along at least the retraction portion of the sleeve with a twist angle of 170-190 degrees between the proximal and distal ends of the sleeve.

[0269] In some applications of the present invention, an actuatable adjustment mechanism is further included, the actuatable adjustment mechanism being coupled to the retraction member and being configured to adjust the size of the sleeve by applying tension to the retraction member when actuated.

[0270] In some applications of the present invention, the contraction member has a first end connected to the adjustment mechanism and a second end connected to the implant sleeve, and when the contraction member is spirally arranged around the sleeve axis, the adjustment mechanism twists from the second end of the contraction member at a twisting angle between 140-180 degrees.

[0271] According to some applications of the present invention, there is further provided a device for an object, the device comprising:

[0272] a base body portion transluminally advanceable into a subject having a distal end, a proximal end, and a length therebetween as measured along a longitudinal axis of the base body portion; and

[0273] Longitudinal contraction member:

[0274] coupled to the basic body portion such that tensioning the contraction member reduces the length of the basic body portion, and

[0275] The constriction member is coupled to the basic body portion such that in the absence of twisting of the basic body portion about the longitudinal axis, at least a portion of the constriction member is helically arranged about the longitudinal axis.

[0276] According to some applications of the present invention, there is further provided a device for an object, the device comprising:

[0277] an annuloplasty structure having a basic body portion, the annuloplasty structure being transluminally advanceable into a subject; and

[0278] Longitudinal contraction member:

[0279] coupled to the annuloplasty structure such that tensioning the contraction member reduces the length of the substantial body portion of the annuloplasty structure, and

[0280] Weaving through the basic body several times,

[0281] The base body portion of the annuloplasty structure defines first and second apertures, with the portion of the retraction member exiting the base body portion through the first aperture and reengaging the base body portion through the second aperture.

[0282] In some applications of the present invention:

[0283] The basic body portion includes a sleeve defining a cavity therethrough,

[0284] The contraction member is interwoven inside and outside the lumen of the sleeve, and

[0285] The sleeve defines first and second apertures, with a portion of the retraction member exiting the sleeve through the first aperture and reentering the lumen of the sleeve through the second aperture.

[0286] In some applications of the present invention, the second hole is arranged at a distance of 16-22 mm from one end of the basic body portion.

[0287] In some applications of the present invention, the basic body portion defines a constriction-free member segment of the basic body portion between the first and second cavities, the constriction-free member segment having a lower degree of friction than a segment of the basic body portion adjacent to the first and second cavities and the constriction-free member segment.

[0288] In some applications of the present invention, the apparatus further includes an actuatable adjustment mechanism coupled to the contraction member and configured to adjust the size of the substantial body portion of the annuloplasty structure by applying tension to the contraction member when actuated.

[0289] In some applications of the present invention, the retraction member has a first end coupled to the adjustment mechanism, and a second end coupled to the general body portion of the annuloplasty structure.

[0290] In some applications of the present invention, the device further includes a contraction member protection element having a first end connected to the basic body portion of the annuloplasty structure and a second end connected to the adjustment mechanism, and the contraction member extends from the adjustment mechanism to the basic body portion of the annuloplasty structure via the contraction member protection element.

[0291] In some applications of the present invention, the first end of the retraction member protection element is connected to the annuloplasty structure at a connection point that is at least 10 mm from either end of the annuloplasty structure.

[0292] In some applications of the present invention, the first and second holes are arranged near the connection point.

[0293] According to some applications of the present invention, there is also provided a device for an object, the device comprising:

[0294] an annuloplasty structure having a basic body portion, the annuloplasty structure being transluminally advanceable into a subject; and

[0295] a longitudinal contraction member coupled to the annuloplasty structure such that tensioning the contraction member reduces the length of a substantial body portion of the annuloplasty structure,

[0296] The annuloplasty structure defines a first portion such that a first degree of friction exists between the base body portion and the first portion of the contraction member, and

[0297] The annuloplasty structure defines a second portion such that a second degree of friction exists between the base body portion and the second portion of the contraction member, the second degree of tension being less than the first degree of tension.

[0298] In some applications of the present invention:

[0299] The first portion of the contraction member is interwoven multiple times through the substantial body portion of the first portion of the annuloplasty structure, and

[0300] The second portion of the annuloplasty structure defines first and second apertures in the base body portion of the annuloplasty structure, and the second portion of the retraction member exits the base body portion through the first aperture and rejoins the base body portion through the second aperture.

[0301] According to some applications of the present invention, a device is also provided, the device comprising:

[0302] a tube having a distal end configured to be advanced into a heart of a patient;

[0303] An implant at least partially movable through a lumen, the implant comprising:

[0304] An annuloplasty structure having a main body portion;

[0305] a constriction member extending at least along the constriction portion of the annuloplasty structure and extending until 10-15 mm from one end of the main body portion; and

[0306] an actuatable adjustment mechanism coupled to the contraction member and configured to adjust the length of the annuloplasty structure by applying tension to the contraction member when actuated,

[0307] When the retraction member is fully disposed within the tube, a portion of the adjustment mechanism is disposed distally of the distal end of the tube.

[0308] In some applications of the present invention, the adjustment mechanism is movable relative to the basic body portion.

[0309] According to some applications of the present invention, a device is also provided, the device comprising:

[0310] a tube having a distal end configured to be advanced into a heart of a patient;

[0311] An implant at least partially movable through a lumen, the implant comprising:

[0312] An annuloplasty structure having a main body portion;

[0313] a constriction member extending at least along the constriction portion of the annuloplasty structure and extending until 10-15 mm from one end of the main body portion; and

[0314] an actuatable adjustment mechanism coupled to the contraction member and configured to adjust the length of the annuloplasty structure by applying tension to the contraction member when actuated,

[0315] The distal-most portion of the constriction member is disposed distally of the distal end of the tube at a first distance therefrom, and a portion of the adjustment mechanism is disposed distally of the constriction member at a second distance therefrom, the second distance being greater than the first distance.

[0316] According to some applications of the present invention, the following inventive ideas are also provided:

[0317] 1. Methods, including:

[0318] advancing a distal end of an anchor driver including a shaft, a tissue piercing lance, and a deployment element through the catheter and toward tissue of the subject;

[0319] Subsequently, the tissue is pierced with a spear;

[0320] deflecting a distal portion of the shaft relative to another portion of the shaft proximally adjacent to the distal portion by moving a distal section of the catheter while at least some of the lances are disposed within the tissue; and

[0321] The tissue engaging member of the anchor is driven into tissue using the anchor driver while (i) the distal portion of the shaft is deflected relative to the other portion of the shaft, and (ii) the deployment element is locked to the head of the anchor.

[0322] 2. A method for implanting a body, the method comprising:

[0323] advancing the implant percutaneously through the catheter toward an implantation site in the subject using an implant manipulation handle coupled to the implant;

[0324] Sliding the implant relative to the catheter by applying a first force to the implant handle without causing the implant to apply force to tissue at the implantation site;

[0325] measuring a magnitude of a first force;

[0326] Subsequently, the implant is anchored to the tissue at the implantation site;

[0327] Subsequently, applying a second force to the implant handle causes the implant to apply a third force to the tissue at the implant site via the implant anchor;

[0328] measuring a magnitude of a second force; and

[0329] A magnitude of the third force is determined at least in part in response to a difference between the magnitude of the first force and the magnitude of the second force.

[0330] 3. According to the method described in inventive concept 2, applying a first force to the implant manipulation handle to make the implant slide includes applying the first force to the implant manipulation handle to make the implant slide proximally relative to the catheter.

[0331] 4. The method according to inventive concept 2, wherein:

[0332] Measuring the magnitude of the first force includes measuring the magnitude of the first force using a dynamometer,

[0333] Measuring the magnitude of the second force includes measuring the magnitude of the second force using a force gauge, and

[0334] The method further includes, after measuring the magnitude of the first force and before causing the implant to apply a third force, zeroing the force gauge to the magnitude of the first force.

[0335] 5. The method according to inventive concept 2, wherein:

[0336] The anchor handle includes a dynamometer,

[0337] Measuring the magnitude of the first force includes measuring the magnitude of the first force using a dynamometer, and

[0338] Measuring the magnitude of the second force includes measuring the magnitude of the second force using a force gauge.

[0339] 6. According to the method of any one of inventive concepts 2 to 5, anchoring the implant comprises anchoring the implant by driving a tissue anchor into tissue at the implantation site.

[0340] 7. According to the method of inventive concept 6, applying the second force to the implant manipulation handle causes the implant to apply the third force, which includes applying the second force to the implant manipulation handle to cause the implant to apply the third force via the tissue anchor.

[0341] 8. A method of using an adjustment tool on an implant, the method comprising:

[0342] implanting an implant transluminally in a heart of a subject such that a guide wire extends from an adjustment device of the implant, the adjustment device comprising an adjustment mechanism and a lock, the adjustment mechanism being configured to change a size of the implant upon actuation of the adjustment mechanism, and the lock having (i) a locked state, wherein the lock inhibits actuation of the adjustment mechanism, and (ii) an unlocked state, wherein the adjustment mechanism is actuatable;

[0343] Subsequently, the adjustment tool is advanced along and over the guide wire to the adjustment device;

[0344] Then, the adjustment mechanism is actuated using the tool while the lock is in the unlocked state;

[0345] Subsequently, the lock is unlocked using the tool and the tool is withdrawn along the guide wire and over the guide wire away from the adjustment device, leaving the lock in a locked state;

[0346] While the tool is still withdrawn and connected to the adjustment device only by the guidewire, observe the function of the heart;

[0347] Subsequently, returning the adjustment tool along the guide wire and over the guide wire to the adjustment device, and using the tool to: unlock the lock, and actuate the adjustment mechanism; and

[0348] Subsequently, (i) the lock is locked using the tool, and the guidewire is decoupled from the locking device, and (ii) the guidewire and tool are withdrawn from the subject.

[0349] 9. Methods, including:

[0350] percutaneously advancing an implant including a sleeve defining a tubular sidewall and a lumen toward tissue of the subject with a distal portion of an anchor delivery channel disposed within the lumen such that a distal opening of the channel is disposed at a first portion of the sleeve;

[0351] anchoring the first portion of the sleeve to the first tissue site by driving the tissue coupling element of the first anchor through the distal opening of the passage, through the sidewall of the first portion of the sleeve, and into the first tissue site using an anchor driver;

[0352] pressing a second portion of the sleeve against a second tissue site; and

[0353] The second portion of the sleeve is anchored to the second tissue site by driving the tissue coupling element of the second anchor from outside the lumen through the opposite side of the sidewall of the second portion of the sleeve and into the second tissue site.

[0354] 10. The method according to inventive concept 9, wherein pressing the second portion of the sleeve against the second tissue site comprises pressing the second portion of the sleeve against the second tissue site such that opposite sides of the sidewalls at the second portion of the sleeve contact each other.

[0355] 11. The method according to inventive concept 9, wherein:

[0356] The implant comprises a valvuloplasty structure, the valvuloplasty structure comprising a sleeve,

[0357] Anchoring the first portion of the sleeve to the first tissue site includes anchoring the first portion of the sleeve to an annulus of an atrioventricular valve of the subject's heart, and

[0358] Anchoring the second portion of the sleeve to the second tissue site includes anchoring the second portion of the sleeve to a wall of an atrial cavity of the subject's heart.

[0359] 12. Methods, comprising:

[0360] percutaneously advancing an implant including the sleeve toward tissue of a subject with the distal portion of the anchor delivery channel disposed within the lumen defined by the sleeve such that the distal opening of the channel is disposed at the first portion of the sleeve;

[0361] anchoring a first portion of the sleeve to the tissue by driving a tissue coupling element of the first anchor through the distal opening of the passage, through the sleeve, and into the tissue using an anchor driver;

[0362] subsequently, while providing a distally directed reference force to the first anchor via the driver, proximally withdrawing the distal portion of the channel such that the distal opening of the channel is disposed at the second portion of the sleeve;

[0363] Thereafter, withdrawing the driver proximally through the passage; and

[0364] Subsequently, the tissue coupling element of the second anchor is driven through the distal opening of the passage, through the sleeve, and into the tissue. The second portion of the sleeve is anchored to the tissue.

[0365] 13. Methods, comprising:

[0366] An implant is provided, the implant comprising:

[0367] An annuloplasty structure having a main body portion;

[0368] a constriction member having (1) a first portion extending at least along a constriction portion of the valvuloplasty structure, and (2) a second portion extending away from a main body portion of the valvuloplasty structure; and

[0369] an actuatable adjustment mechanism coupled to the second portion of the contraction member, the second portion of the contraction member extending away from the main body portion and toward the adjustment mechanism, the adjustment mechanism being configured to adjust the length of the main body portion of the annuloplasty structure by applying tension to the contraction member when actuated; and

[0370] delivering the implant to a chamber of the subject's heart via a catheter with the adjustment mechanism disposed distally of the main body portion of the valvuloplasty structure;

[0371] deploying a portion of the annuloplasty structure in the chamber such that the adjustment mechanism is 10-15 mm from the main body of the annuloplasty structure via the second portion of the contraction member; and

[0372] After deployment, the distance between the adjustment mechanism and the main body portion is reduced by actuating the adjustment mechanism.

[0373] 14. Methods, comprising:

[0374] advancing the catheter transluminally into the subject;

[0375] providing an implant comprising a flexible sleeve defining a cavity having a proximal end, a distal end and a central longitudinal axis therebetween; and

[0376] The implant is advanced through the catheter as the flexible sleeve wraps around the distal portion of the passageway while twisting about the sleeve axis.

[0377] 15. According to the method of inventive concept 14, providing the implant further comprises providing a channel, and the flexible sleeve covers the distal portion of the channel when twisted about the axis.

[0378] 16. According to the method of inventive concept 14, the torsion angle between the proximal end and the distal end is 170-190 degrees.

[0379] 17. The method of inventive concept 14, further comprising, after advancement, progressively releasing successive portions of the sleeve from the channel and anchoring the successive portions to the subject's tissue such that a torsion angle of the sleeve is reduced.

[0380] 18. According to the method of inventive concept 14, providing an implant comprises providing an implant comprising:

[0381] a retraction member extending longitudinally along the sleeve; and

[0382] An actuatable adjustment mechanism is coupled to the contraction member and is configured to adjust the size of the implant by applying tension to the contraction member when actuated.

[0383] 19. According to the method described in inventive concept 18, the contraction member has a first end connected to the adjustment mechanism and a second end connected to the implant sleeve, and when the sleeve is twisted around the sleeve axis, the adjustment mechanism is twisted from the second end of the contraction member at a twisting angle between 170-190 degrees.

[0384] 20. The method according to inventive concept 18, providing the implant further comprises providing a channel, wherein the flexible sleeve covers a distal portion of the channel when twisted about the sleeve axis.

[0385] 21. The method according to inventive concept 20 further comprises, before advancing the implant, rotating the implant around the central longitudinal axis of the channel in a first rotational direction while the sleeve covers the distal portion of the channel when twisting around the sleeve axis.

[0386] 22. A method for treating a heart of a subject, the method comprising:

[0387] Advancing an implant to a site in the heart using an implant assembly, the implant comprising an implant adjustment mechanism coupled to a flexible wire of the implant assembly, the implant assembly further comprising an adjustment tool slidable along and through the flexible wire and reversibly engageable with the implant adjustment mechanism;

[0388] securing the implant at a location in the heart such that the flexible wire extends from the implant adjustment mechanism to outside the heart;

[0389] subsequently, actuating the implant adjustment mechanism with the adjustment tool while the adjustment tool is disposed on the flexible wire and engaged with the implant adjustment mechanism;

[0390] subsequently, disengaging and withdrawing the adjustment tool from the implant adjustment mechanism by moving the adjustment tool along and through the flexible wire while the flexible wire is still coupled to the implant adjustment mechanism;

[0391] subsequently, detecting a parameter of the heart while (i) the adjustment tool is still withdrawn from the implant adjustment mechanism, and (ii) the flexible wire is still coupled to the implant adjustment mechanism;

[0392] subsequently reengaging the adjustment tool with the implant adjustment mechanism by moving the adjustment tool along and through the flexible wire toward the implant adjustment mechanism while the flexible wire is still coupled to the implant adjustment mechanism; and

[0393] The implant adjustment mechanism is then re-actuated using the adjustment tool while the adjustment tool is disposed over the flexible wire and engaged with the implant adjustment mechanism.

[0394] 23. According to the method of inventive concept 22, detecting the cardiac parameter includes detecting the cardiac parameter when the flexible wire is the only part of the implant component in contact with the implant body.

[0395] 24. The method according to inventive concept 22 further comprises:

[0396] locking the implant adjustment mechanism after actuating the implant adjustment mechanism and before withdrawing the adjustment tool; and

[0397] After moving the adjustment tool along and through the flexible wire toward the implant adjustment mechanism and before re-actuating the implant adjustment mechanism, the adjustment mechanism is unlocked.

[0398] 25. According to the method described in inventive concept 24, locking the implant adjustment mechanism includes locking the implant adjustment mechanism using an implant component, and unlocking the implant adjustment mechanism includes unlocking the implant adjustment mechanism using an implant component.

[0399] 26. The method according to inventive concept 22, further comprising, after re-actuating the implant adjustment mechanism, decoupling the flexible wire from the adjustment mechanism.

[0400] 27. According to the method of inventive concept 26, decoupling the flexible wire from the implant adjustment mechanism includes decoupling the flexible wire from the implant adjustment mechanism using an implant component.

[0401] 28. The method according to inventive concept 26, further comprising relocking the implant adjustment mechanism before decoupling the flexible wire from the adjustment mechanism.

[0402] 29. According to the method of inventive concept 22, detecting the cardiac parameters comprises detecting the cardiac parameters using echocardiography.

[0403] The present invention will be more fully understood through the following detailed description of its embodiments in conjunction with the accompanying drawings, which are as follows. BRIEF DESCRIPTION OF THE DRAWINGS

[0404] Figure 1 is a schematic diagram of an annuloplasty ring structure including a sleeve and an adjustment mechanism according to some applications of the present invention;

[0405] Figure 2 is a schematic diagram 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 according to some applications of the present invention;

[0406] Figure 3A -G is a schematic diagram of steps for implanting an annuloplasty ring structure to repair a mitral valve according to some applications of the present invention;

[0407] Figure 4A and 4B According to the respective application display of the present invention Figure 3C The status and Figure 3D a schematic diagram of the steps between the states shown;

[0408] Figure 5A - B is a schematic diagram of a technique for the sleeve overhang according to some applications of the present invention;

[0409] Fig. 6A -B and 7A-B are schematic diagrams of catheter manipulation according to respective applications of the present invention;

[0410] Fig. 8A-B, 9, 10A-C, 11 and 12A-B are schematic diagrams of tissue anchors according to some applications of the present invention, and applications of the tissue anchors for implantation;

[0411] Fig.13A -D and 14A-F are schematic diagrams of systems including tissue anchors, anchor drivers and lances and techniques for use with the systems according to some applications of the present invention;

[0412] Fig.15A - B is a schematic diagram of an implant including a retraction wire according to some applications of the present invention;

[0413] Fig.16A -B, 17A-C and 18A-K are schematic diagrams of systems and application techniques for docking and adjusting an adjustment mechanism of a percutaneously implantable implant according to some applications of the present invention;

[0414] Fig.19A - F is a schematic diagram of a dynamometer and its application technology according to some applications of the present invention;

[0415] Fig. 20 is a schematic diagram of a valvuloplasty structure in a delivery and implantation state according to some applications of the present invention;

[0416] Fig.21 is a schematic diagram of a valvuloplasty structure in a delivery and implantation state showing a contraction member having an offset region according to some applications of the present invention;

[0417] Fig.22A - C is a schematic diagram of a valvuloplasty structure in a respective twisted and / or rotated state of delivery according to some applications of the present invention;

[0418] Fig.23A -B is a schematic diagram of a valvuloplasty structure including first and second sleeves according to some applications of the present invention;

[0419] Fig.24A -B is a truncated cone scroll spring according to some applications of the present invention Fig.23A -B is a schematic diagram of the annuloplasty structure;

[0420] Fig.25A - B is a schematic diagram of a valvuloplasty structure including a contraction member protection band according to some applications of the present invention;

[0421] Fig.26A -B, 27A-B, 28A-B and 29A-B are schematic diagrams of valvuloplasty structures including respective adjustment indicators according to respective applications of the present invention;

[0422] Fig.30is a schematic diagram of an annuloplasty structure in a sleeve of the annuloplasty structure and a contraction member helically arranged relative to the sleeve of the annuloplasty structure according to some applications of the present invention; and

[0423] Fig.31A - C is a schematic diagram of an annuloplasty structure shaped to define an orifice according to some applications of the present invention. DETAILED DESCRIPTION

[0424] Reference Figure 1-2 , which is a schematic diagram of a multi-component tubular system 10 providing one or more rotationally controlled steering catheters configured to deliver an implant to a subject's heart, according to some applications of the present invention.

[0425] Figure 1 The distal portion of the implant is shown, which includes an annuloplasty ring structure 222 (ie, an implant, such as an annuloplasty band) that includes a flexible sleeve 26 (shown at Figure 2 ). The flexible sleeve 26 generally comprises a braided fabric mesh, for example, comprising polyethylene terephthalate (such as Dacron (TM)). The flexible sleeve 26 is generally configured to be arranged only partially around the heart valve annulus (i.e., in a C-shape), and to contract to circumferentially tighten the annulus after being anchored in place. Optionally, the ring structure is configured to be arranged completely around the annulus.

[0426] The flexible sleeve 26 has (a) a tubular side wall 253 that (i) defines a central longitudinal axis of the sleeve, and (ii) defines a lumen of the sleeve, and (a) at least one end wall 251 (e.g., a distal end wall) having a surface that is substantially transverse to the side surface of the tubular wall 253. In general, the end wall 251 defines an end wall of the annuloplasty ring structure 222.

[0427] To tighten the annulus, the annuloplasty ring structure 222 includes a flexible elongate contraction member 226 extending along the flexible sleeve 26. The elongate contraction member 226 includes a wire, a ribbon, a cord, or a band, generally including a flexible and / or superelastic material, such as nitinol, polyester, stainless steel, or cobalt chromium. 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, the contraction member 226 includes a plurality of wires entangled with each other to form a cord structure.

[0428] The annuloplasty ring structure 222 further includes an adjustment mechanism 40 that facilitates contraction and expansion of the annuloplasty ring structure 222, thereby facilitating adjustment of the circumference of the annulus and leaflets of the heart valve. The adjustment mechanism 40 is described in more detail below. The adjustment mechanism 40 includes a rotatable structure (e.g., a reel, as described below) disposed within a housing 44. For some applications of the present invention, the adjustment mechanism 40 includes the housing 44. The adjustment mechanism 40 may be surrounded by a braided mesh that is coupled (e.g., by suturing or otherwise coupled) to the braided mesh of the flexible sleeve 26. For some applications, the adjustment mechanism 40 is coupled to an exterior side surface of the flexible sleeve 26.

[0429] Reference Figure 2 , which shows the concentric relationship between the components of the tubular system 10 ( Figure 2 1 and 12). The system 10 includes an implant delivery tool. Generally, the system 10 includes a first outer catheter 12, which includes a sheath configured to be advanced transluminally through the vascular system of the subject. For some applications of the present invention, the outer catheter 12 includes a sheath configured to be advanced through the femoral artery toward the atrial septum of the heart of the subject. The distal end 112 of the outer catheter 12 is configured to pass through the transatrial septum of the subject and be oriented in a desired spatial orientation within the left atrium. The system 10 includes a second catheter, or guide catheter 14, which includes a distal end 114 configured to pass through the outer catheter 12 (i.e., its first lumen) to be disposed outside the distal end 102 of the outer catheter and oriented in a desired spatial orientation within the left atrium.

[0430] The distal portion 112 of the outer catheter 12 is steerable. That is, the distal portion 112 is deflectable relative to the immediately proximal portion of the outer catheter 12 (e.g., by utilizing an extracorporeal component of the system 10). The distal portion 112 includes a pull ring 11 that is coupled to two or more pull wires 29a and 29b that are disposed in respective second lumens within the side wall of the outer catheter 12 (e.g., Figure 2 As shown in the exploded view, the guide catheter 14 is configured to be concentrically disposed within the lumen of the outer catheter 12. The distal end 114 of the guide catheter 14 is steerable. That is, the distal end 114 is deflectable relative to the immediately proximal portion of the guide catheter 14 (e.g., by utilizing an extracorporeal element of the system 10). The distal end 114 includes a pull ring 13 that is coupled to two or more pull wires 31a and 31b that are disposed in respective second lumens within the wall of the guide catheter 14 (as shown in sections AA and BB).

[0431] The guide catheter 14 is maneuverable to a desired spatial orientation to facilitate advancement and implantation of the implant within a body lumen of a subject.

[0432] For applications of the system 10 for delivering an implant to a subject's mitral valve, generally, the outer catheter 12 is configured to be initially advanced through the subject's vascular system until the distal end 102 of the outer catheter 12 is positioned in the left atrium. The distal steerable end of the outer catheter 12 is then steered so that the distal end 102 of the outer catheter 12 is positioned within the left atrium in a desired spatial orientation. The steerage procedure is generally performed with the aid of imaging such as fluoroscopy, transesophageal echo, and / or echocardiography. After steerage of the distal end of the outer catheter 12, the guide catheter 14 (containing the annuloplasty ring structure 222) is advanced through the outer catheter 12 to facilitate delivery and implantation of the annuloplasty ring structure 222 along the mitral valve annulus. During delivery, at least a portion of the steerable distal end 114 is exposed from the distal end 102 of the outer catheter 12 and is thus free for steerage toward the mitral valve annulus, as described below.

[0433] During delivery of the flexible sleeve 26 to the heart valve annulus, the flexible sleeve 26 and the adjustment mechanism 40 are disposed within the lumen of the guide catheter 14 and are generally longitudinally aligned with the longitudinal axis of the guide catheter 14. The adjustment mechanism 40 is coupled to the flexible sleeve 26 in a manner that allows the adjustment mechanism 40 to be adjusted from a state in which it is collinear with the longitudinal axis of the guide catheter 14 ( Figure 2 ) moves (e.g., translates) to a state where it is arranged side by side with the flexible sleeve 26 ( Figure 1 For example, the adjustment mechanism 40 can be coupled to the flexible sleeve 26 via one or more connectors 27, such as sutures, that provide a flexible and / or articulated connection. For some applications, the positioning of the adjustment mechanism 40 and a portion of the flexible sleeve 26 side by side enables the drive interface (e.g., drive interface 476, Fig.16A ) is exposed, providing access to the interface for an adjustment tool which is subsequently guided toward the adjustment mechanism 40 via the guide member 86.

[0434] Reference again Figure 1 . A guide member 86 (e.g., a wire) is coupled to a portion of the adjustment mechanism 40 (e.g., a portion of a rotatable structure, as described below). The guide member 86 has a thickness of 0.35-0.45 mm, for example, 0.4 mm. The guide member 86 is configured to facilitate guiding of an adjustment tool via the guide member 86 and toward the rotatable structure of the adjustment mechanism 40. Generally, the adjustment tool is configured to engage the rotatable structure of the adjustment mechanism 40 after the flexible sleeve 26 is implanted along the annulus of the heart valve. The guide member 86 extends from the adjustment mechanism 40, parallel to a portion of the distal end 114 of the guide catheter 14, and enters a second lumen within the wall of the guide catheter 14 through an opening 15 in the guide catheter 14. The guide member 86 extends through the second lumen of the guide catheter 14 (e.g., Figure 2AA and BB of the embodiment of the present invention) and having a proximal end accessible from outside the subject's body. The second lumen within the wall of the guide catheter 14 facilitates the passage of the guide member 86 through the system 10 without interfering with other concentrically arranged elongated tubular members that pass concentrically through the lumen of the guide catheter 14.

[0435] Reference again Figure 2 In addition, the system 10 includes a plurality of anchors 32, generally between about 5 and about 20 anchors, such as about 10 or about 16 anchors. Each anchor 32 includes a tissue coupling element 60 (e.g., a helical tissue coupling element), and a tool engagement head 62 (e.g., a non-helical shaped portion) secured to one end of the tissue coupling element. Figure 2 6 shows only one anchor 32 reversibly coupled to the deployment element 38 of the anchor driver 36 of the manipulator 61. However, each anchor 32 can be reversibly coupled to the deployment element 38 of one or more anchor drivers 36. When the flexible sleeve 26 is arranged along the heart valve annulus, the manipulator 61 is configured to advance within the cavity of the flexible sleeve 26 and deploy each anchor 32 from within the flexible sleeve 26 through the wall of the flexible sleeve 26 into the heart tissue, thereby anchoring the flexible sleeve 26 around a portion of the annulus. Insertion of the anchors in the sleeve and deployment of the anchors in the heart tissue are described in detail below.

[0436] Typically, but not necessarily, anchor 32 comprises a biocompatible material, such as stainless steel 316LVM. For some applications, anchor 32 comprises Nitinol. For some applications, anchor 32 is fully or partially coated with a non-conductive material.

[0437] Manipulator 61 includes anchor driver 36 and deployment element 38. For some applications, manipulator 61 includes implant disengagement channel 18.

[0438] like Figure 2 As shown in the exploded view of FIG. 1 , the flexible sleeve 26 is arranged in the lumen of the guide catheter 14. A force can be applied to the proximal end of the flexible sleeve 26 via the reference force tube 19, and the distal end of the reference force tube 19 is connected to the proximal end of the sleeve. As shown, the implant decoupling channel 18 can be advanced in the lumen of the reference force tube 19 and the lumen of the flexible sleeve 26. Figure 1 As shown in the enlarged image of , the distal end 17 of the implant disengagement channel 18 can be arranged to contact the inner wall of the flexible sleeve 26, for example, at its distal end. The distal end of the implant disengagement channel 18 may include a radiopaque marker 1018. As shown, the reference force tube 19 and the flexible sleeve 26 are arranged longitudinally and coaxially relative to each other.

[0439] For some applications, implant disengagement passage 18 is steerable.

[0440] In general, the manipulator 61 is advanced within the implant disassociation channel 18. For some applications, the system 10 includes a plurality of anchor drivers 36 of the manipulator 61, each driver 36 being coupled to a respective anchor 32. Each driver 36 is advanced within the implant disassociation channel 18 to advance and implant the anchor 32 in the tissue. After the anchor 32 is implanted, the anchor 32 is disassociated from the driver 36 as described herein, and the driver 36 is removed from the implant disassociation channel 18. A subsequent anchor 32 is then advanced within the implant disassociation channel 18 while being coupled to a driver 36 (e.g., a new driver).

[0441] As described below, the first anchor 32 is configured to be deployed into the cardiac tissue through the end wall 251 of the flexible sleeve 26 when the flexible sleeve 26 is positioned along the valve annulus. After the first tissue anchor is deployed, the distal portion of the flexible sleeve 26 is slid distally over a portion of the implant disengagement passage 18. To disengage the flexible sleeve 26 distally from a portion of the outer surface of the implant disengagement passage 18, (1) a proximal force is applied to the implant disengagement passage 18 while (2) the reference force tube 19 is held in place in such a manner that the distal end of the reference force tube 19 provides a reference force to the flexible sleeve 26, thereby facilitating disengagement of successive portions of the flexible sleeve 26 from around the implant disengagement passage 18. The implant disengagement passage 18 is then located at successive locations within the lumen of the flexible sleeve 26 while the reference force tube 19 and / or the guide catheter 14 are manipulated toward successive locations along the valve annulus (as described below). As such, successive portions of the flexible sleeve 26 provide free lumens for advancing successive anchors 32 and deploying them through the sleeve wall at successive portions thereof. This release of successive portions of the flexible sleeve 26 creates a distance between deployments of successive anchors within the flexible sleeve 26 lumen.

[0442] For some applications, the flexible sleeve 26 includes a plurality of radiopaque markers 25 positioned at respective longitudinal locations along the sleeve. The markers can provide an indication in a radiographic image (e.g., a fluoroscopic image) of how much of the sleeve has been deployed at a given location during an implantation procedure to enable setting of a desired distance between anchors 32 along the sleeve. For some applications, the markers include radiopaque ink.

[0443] Typically, at least some (e.g., at least three, such as all) of the longitudinal sites are longitudinally spaced at constant intervals. Typically, the longitudinal distance between the distal edges of adjacent / continuous marks and / or the distance between the proximal edges of adjacent marks are set equal to the desired distance between adjacent anchors. For example, the markings may include a first, second, and third marking, the first and second markings being adjacent, and the second and third markings being adjacent, and the distance between the proximal and / or distal edges of the first and second markings being equal to the corresponding distance between the proximal and / or distal edges of the second and third markings. For example, the distance may be between 3 and 15 mm, such as 6 mm, and the longitudinal length of each marking may be between 0.1 and 14 mm, such as 2 mm. (If, for example, the distance is 6 mm and the length is 2 mm, the longitudinal gap between adjacent markings will have a length of 4 mm.)

[0444] Each anchor 32 is coupled to a deployment element 38 of an anchor driver 36. The anchor driver 36 generally includes an elongated and flexible shaft (which is generally tubular) having at least a flexible distal portion. The elongated shaft of the driver 36 extends within the cavity of the implant disengagement channel 18, through the system 10, and toward the proximal end of the proximal handle portion 101 of the system 10. The tube of the anchor driver 36 provides a cavity through which an elongated rod 130 can be slidably advanced. The elongated rod 130 facilitates the locking and unlocking of the anchor 32 to the deployment element 38. Figure 2 As shown in section EE of FIG. 1 , the proximal end of the extension 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 engagement device 131 coupled to the proximal end of the extension rod 130. The finger engagement device 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. The anchor 32 is released from the deployment element 38 when the physician pulls the finger engagement device 131 proximally to pull the extension rod 130 proximally.

[0445] The proximal handle portion 101 is supported by a base having support legs 91 and a handle slide 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, in general, the annuloplasty ring structure 222) to move through the guide 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 the various concentrically arranged components of the system 10 is shown in FIG. Figure 2 Exploded views and sections AA, BB, CC and DD.

[0446] The base supports the proximal handle 101 to be moved distally and proximally to control the position of the entire multi-component system 10, specifically to adjust the distance of the distal end 102 of the outer catheter 12 from the atrial septum. The handle 22 includes a manipulation knob 210, which is connected to the manipulation wires 29a and 29b disposed in respective second lumens in the wall of the outer catheter 12. Rotation of the knob 210 adjusts the degree of tension of the wires 29a and 29b, thereby applying force to the pull ring 11 at the distal end of the outer catheter 12. This force manipulates the distal end of the outer catheter 12 in the atrium of the subject's heart in the following manner: the distal end of the outer catheter 12 is manipulated in a first manipulation plane generally parallel to the plane of the valve annulus (e.g., in a direction from the atrial septum to the atrial wall). For some applications of the present invention, the distal end of the outer catheter 12 can be pre-shaped so as to point downwardly toward the valve. For other applications, the distal end of the outer catheter 12 can be pulled to present the following orientation: the distal end points downwardly toward the valve. For still other applications of the present invention, the distal end of the outer catheter 12 is not directed downwardly toward the valve.

[0447] The handle 24 is coupled to the track 90 via a first fixture 92. The fixture 92 is slidable proximally and distally along the track 90 to control the axial position of the guide catheter 14 relative to the outer catheter 12. The fixture 92 is slidable via a control knob 216. For example, the control knob 216 of the fixture 92 controls the axial movement of the distal steerable portion of the guide catheter 14 proximally and distally relative to the distal end 102 of the outer catheter 12. The handle 24 includes a steering knob 214 that is coupled to respective second intraluminal steering wires 31a and 31b disposed in the wall of the guide catheter 14. Rotation of the knob 214 adjusts the degree of tension of the wires 31a and 31b, thereby applying force to the pull ring 13 at the distal end of the guide catheter 14. This force steers the distal end of the guide catheter 14 within the atrium of the subject's heart in a second steering plane, generally downward and toward the heart valve annulus. Typically, as described below, the distal end of guide catheter 14 is steered within a second plane that is substantially perpendicular relative to a first plane in which the distal end of outer catheter 12 is steered.

[0448] The combined manipulation of the distal ends of the outer catheter 12 and the guide catheter 14 guides the flexible sleeve 26 - downward toward the annulus (e.g., via manipulation of the distal end of the guide catheter 14), and along the circumference of the annulus (e.g., from the posterior segment of the valve to the anterior segment of the valve, and vice versa) (via manipulation of the distal end of the outer catheter 12).

[0449] For some applications, handle 22 may be tilted by the operating physician to further adjust the position of the distal end of outer catheter 12 .

[0450] The handle 126 is slidably coupled to the track 90 via a second fixture 93. The fixture 93 is slidable proximally and distally along the track 90 to control the axial position of the reference force tube 19 and at least the proximal portion of the flexible sleeve 26 relative to the guide catheter 14. For some applications, the fixture 93 includes a control knob 95. For some such applications, the control knob reversibly locks the fixture 93 to the track 90, thereby reversibly inhibiting the sliding of the fixture along the track. Alternatively or additionally, twisting of the control knob 95 can cause the fixture 93 to slide along the track 90 (e.g., behave like a rack and pinion). For some applications, the friction between (i) the reference force tube 19 and (ii) the guide catheter 14 and / or the handle 24 reduces the likelihood of accidental sliding of the reference force tube 19 through the guide catheter 14, thereby eliminating the need to lock the fixture 93 to the track 90. In conjunction with manipulation of the distal end of the guide catheter 14, such movement of the reference force tube 19 and at least the proximal flexible sleeve 26 causes the proximal portion of the flexible sleeve 26 to move toward a desired portion of the valve annulus tissue during deployment of the anchor 32 from within the lumen of the flexible sleeve 26, as described below.

[0451] As described above, to disengage the flexible sleeve 26 from a portion of the outer surface of the implant disengagement channel 18, (1) the implant disengagement channel 18 is pulled proximally while (2) maintaining the reference force tube 19 in place. The proximal end of the implant disengagement channel 18 is coupled to a knob 94 that adjusts the axial position of the implant disengagement channel 18 proximally and distally relative to the reference force tube 19 and the flexible sleeve 26.

[0452] Typically, the handle 101 includes a release decision facilitating member 127, such as a latch or a button, which automatically engages when a given length of the flexible sleeve 26 has been pushed out of the implant disassembly channel 18 (e.g., when the implant disassembly channel 18 is in a given position relative to the reference force tube 19), typically just before the flexible sleeve 26 is completely disengaged from the implant disassembly channel 18. The engagement of the member 127 inhibits proximal movement of the implant disassembly channel 18 relative to the reference force tube 19, thereby reducing (e.g., preventing) the possibility of accidental release of the flexible sleeve 26. To release the flexible sleeve 26 (e.g., disengage the implant disassembly channel 18 from the sleeve), the operating physician must disengage the member 127—e.g., by pressing a button—before continuing to withdraw the implant disassembly channel 18 proximally. Typically, when engaged, the member 127 also inhibits distal movement of the implant disassembly channel 18 relative to the reference force tube 19.

[0453] The handle 101 (including the handles 22, 24 and 126 and the anchor release mechanism 28) has a length L1 between 65 and 85 cm, for example, 76 cm. Generally, as shown, the main body portion of the outer catheter handle 22 is mostly arranged at a non-zero angle relative to the longitudinal axis 7 of the multiple components of the system 10. The steering mechanism provided by the handle 22 for manipulating the end of the outer catheter 12 is arranged in the portion of the handle 22 arranged at a non-zero angle relative to the axis 7. The handle 22 includes a colinear tubular portion that is colinear along the axis 7 and is coaxially arranged longitudinally relative to the handles 24 and 126 and the release mechanism 28. The colinear tubular portion is shaped to define a cavity for inserting the guide catheter 14 therethrough and subsequently inserting the cavity of the outer catheter 12. The colinear tubular portion has a length L24 between 7 and 11 cm, for example, 7 cm. This spatial orientation of the handle 22 at a certain angle relative to the axis 7 reduces the overall functional length of the handle 101.

[0454] Typically, but not necessarily, the guide wire 2244 extends alongside the flexible sleeve 26 to facilitate positioning of the flexible sleeve 26 along the annulus.

[0455] refer to Figure 3A -G and 4A-B, which are schematic illustrations of steps for implanting an annuloplasty ring structure to repair a mitral valve according to some applications of the present invention. This procedure is one exemplary procedure that may be performed using system 10.

[0456] The anchor manipulator 61 is advanced into the lumen of the flexible sleeve 26 and the anchor is deployed from within the lumen through the sleeve wall into the heart tissue, thereby anchoring the sleeve around a portion of the annulus. For some applications, the annuloplasty ring structure 222 is implemented using the technology described in U.S. application Ser. No. 12 / 437,103, filed May 7, 2009, published as US 2010 / 0286767 and / or U.S. application Ser. No. 12 / 689,635, filed January 19, 2010, published as US 2010 / 0280604, both of which belong to the assignee of the present application and are incorporated herein by reference. As described above, the annuloplasty ring structure 222 includes an adjustment mechanism 40. The adjustment mechanism includes a rotatable structure, such as a spool, arranged so that rotation of the rotatable structure contracts the implant structure. The implant further includes a longitudinal member, such as a wire, coupled to the adjustment mechanism. An adjustment tool is provided for rotating the rotatable structure. The tool is configured to be guided along (eg, through, alongside, or across) the longitudinal member to engage the rotatable structure and to rotate the rotatable structure in response to a rotational force applied to the tool.

[0457] The procedure generally begins with advancing a semi-rigid guidewire into the subject's right atrium 220. The procedure is generally performed with the aid of imaging such as fluoroscopy, transesophageal echo, and / or echocardiography.

[0458] The guide wire provides a guide for the outer catheter 12 to be subsequently advanced along it into the right atrium. After the distal portion of the outer catheter 12 enters the right atrium, the guide wire is withdrawn from the subject's body. The outer catheter 12 generally includes a 14-24F sheath, although this size may be selected as appropriate for a given subject. The outer catheter 12 is advanced through the vascular system into the right atrium using an appropriate starting point, which is generally determined based on a given subject. For example:

[0459] The outer catheter 12 may be introduced into the femoral vein of the subject, through the inferior vena cava 223, into the right atrium 220, and through the septum into the left atrium 224, typically through the fossa ovalis;

[0460] The outer catheter 12 may be introduced into the basilic vein, through the subclavian vein to the superior vena cava, into the right atrium 220, and through the septum into the left atrium 224, typically through the fossa ovalis; or

[0461] The outer catheter 12 may be introduced into the external jugular vein, through the subclavian vein to the superior vena cava, into the right atrium 220, and through the septum into the left atrium 224, typically through the fossa ovalis.

[0462] For some applications of the present invention, outer catheter 12 is advanced through the subject's inferior vena cava 223 (as shown) and into the right atrium 220 using an appropriate starting point, which is generally determined based on a given subject.

[0463] The outer catheter 12 is advanced distally until the sheath reaches the atrial septum, and the guidewire is withdrawn.

[0464] The elastic needle and dilator are advanced through the outer catheter 12 and into the heart. To advance the outer catheter 12 through the septum into the left atrium 224, the dilator is advanced to the septum, the needle is pushed out of the dilator and punctured through the septum to create an opening that facilitates the passage of the dilator and the subsequent passage of the outer catheter 12 therethrough and into the left atrium 224. The dilator is passed through the hole created by the needle in the septum. Generally, the dilator is shaped to define a hollow shaft for passing along the needle, and the hollow shaft is shaped to define a tapered distal end. This tapered distal end is first advanced through the hole created by the needle. The hole increases as the dilator distal end, which increases in diameter, is pushed through the hole in the septum. The distal-most end 102 of the outer catheter 12 is tapered to facilitate at least a portion of the distal portion 112 of the outer catheter 12 passing through the opening in the septum.

[0465] After advancing the outer catheter 12 through the septum and into the left atrium, the dilator and needle are withdrawn from the outer catheter 12. After the distal portion 112 of the outer catheter 12 is disposed within the atrium 224, the portion 112 is manipulated (i.e., deflected) within a first manipulation plane that is generally parallel to the annular plane of the mitral valve 230. Manipulation of the distal portion of the outer catheter 12 is accomplished via a manipulation knob 210 (in the handle 101) of the handle 22. Figure 2 in).

[0466] like Figure 3A As shown, a guide catheter 14 containing an annuloplasty ring structure 222 (with the distal portion of the implant disengagement passage 18 disposed within its flexible sleeve 26) is advanced through the outer catheter 12 into the left atrium 224. For some applications, shortly before implantation (e.g., in an operating room or an adjacent room), the distal portion of the implant disengagement passage 18 is loaded into the flexible sleeve 26 and the annuloplasty ring structure 222 is loaded into the guide catheter 14. The distal portion 114 of the guide catheter 14 extends beyond the distal end 102 of the outer catheter 12. The distal portion 114 is then manipulated (i.e., deflected) within a second manipulation plane and further generally toward the annulus of the valve 230, the second manipulation plane being generally perpendicular relative to the manipulation plane of the outer catheter 12. Manipulation of the distal portion of the guide catheter 14 is accomplished via a manipulation knob 214 of the handle 24 in the handle 101 (in a direction that is perpendicular to the outer catheter 12). Figure 2 in).

[0467] Figure 3A The annuloplasty ring structure 222, which includes the flexible sleeve 26 and the adjustment mechanism 40, is shown having been advanced to the mitral valve 230 by the guide catheter 14. Figure 3A As shown, and as described above, during advancement of the annuloplasty ring structure 222, the adjustment mechanism 40 is disposed distally (i.e., anteriorly) to the flexible sleeve 26. In this manner, the adjustment mechanism 40 is disposed on the longitudinal axis of the flexible sleeve 26 (e.g., in-line with the sleeve), thereby advantageously retaining an implant of a small cross-sectional diameter for transluminal delivery. The proximal end of the connector 27 is disposed proximal to the adjustment mechanism 40 (e.g., by being fixed to a portion of the flexible sleeve 26 proximal to the adjustment mechanism 40, or by being accessible outside the subject's body). The distal end of the connector 27 is coupled (e.g., fixedly coupled by tying or other mechanical coupling) to the adjustment mechanism 40. The guide member 86 described above generally extends distally from the guide catheter 14 between the end wall 251 of the flexible sleeve 26 and the adjustment mechanism 40, and is coupled to the adjustment mechanism there. For some applications, it is advantageous to: (1) advance the structure to the mitral valve while the adjustment mechanism 40 is disposed on the longitudinal axis of the flexible sleeve 26 (e.g., co-linear with the sleeve), thereby maintaining the structure of small cross-sectional diameter for transluminal delivery; and (2) subsequently move the adjustment mechanism 40 away from the longitudinal axis, for example, so that the end wall 251 of the sleeve is disposed in close proximity to the valve annulus, and / or so that the anchor is driven through the end wall of the sleeve. The connector 27 facilitates this technique by flexibly and / or articulatingly coupling the adjustment mechanism 40 to the flexible sleeve 26. For some applications, tensioning or relaxing the connector 27 moves the adjustment mechanism 40 relative to the flexible sleeve 26 to reposition the adjustment mechanism 40. For some applications, tensioning or relaxing the guide member 86 to reposition the adjustment mechanism 40.

[0468] After at least the adjustment mechanism 40 (and generally at least the end wall 251 of the flexible sleeve 26) is exposed from the guide catheter 14, the adjustment mechanism is moved away from the end wall 251. Generally, this is accomplished by moving the guide member 86 proximally such that the adjustment mechanism 40 moves (e.g., translates, deflects, and / or rotates) away from the longitudinal axis of the sleeve, generally becoming disposed to the side of the flexible sleeve 26. Figure 3B The adjustment mechanism 40 is shown translated to such a position. The movement of the adjustment mechanism 40 away from the end wall 251 of the flexible sleeve 26 advantageously causes the end wall 251 of the flexible sleeve 26 to be disposed proximate to the atrial surface of the annulus 240 and the first anchor 32 to be driven through the end wall 251 of the sleeve and into the annulus ( Figure 3C ).

[0469] like Figure 3C As shown, the end wall 251 of the flexible sleeve 26 is positioned near the left fiber triangle 242 of the valve ring 240 of the mitral valve 230. (Note that for clarity of illustration, the distal wall 251 of the flexible sleeve 26 is schematically shown in the heart cross-sectional view, although the left triangle 242 is not actually located in the cross-sectional plane shown, but is closer to the viewer out of the page.) Optionally, the distal end of the flexible sleeve 26 is positioned near the right fiber triangle 244 of the mitral valve (configuration not shown). Further optionally, the distal end of the sleeve is not positioned near any triangle, but is positioned at other locations near the mitral valve, such as near the anterior or posterior commissure. After positioning at the desired site near the selected trigone, the manipulator 61 deploys the first anchor 32 through the wall of the flexible sleeve 26 (by penetrating and passing through the sleeve wall - (i) in a direction parallel to the central longitudinal axis of the manipulator 61 or anchor driver 36, through the distal end of the implant disengagement channel 18, and / or (ii) parallel to the central longitudinal axis of the tissue coupling 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 disengaged from the anchor 32.

[0470] The anchors 32 are typically deployed from the distal end of the manipulator 61, with the distal end positioned so that a central longitudinal axis passing through the distal end of the manipulator 61 forms an angle with the surface of the cardiac tissue, the angle being between about 20 and 90 degrees, for example, between 45 and 90 degrees, such as between about 75 and 90 degrees, such as about 90 degrees. Typically, the anchors 32 are deployed from the distal end of the manipulator 61 into the atrial surface of the cardiac tissue in a direction parallel to the central longitudinal axis passing through the distal end of the manipulator 61. Such an angle is typically provided and / or maintained by the implant disengagement channel 18 being more rigid than the flexible sleeve 26. The distal end 17 of the implant disengagement channel 18 is typically positioned close to the cardiac tissue surface (and the wall of the flexible sleeve 26 disposed proximate to the cardiac tissue surface) such that each anchor 32 is barely exposed from the implant disengagement channel 18 prior to penetrating the sleeve and tissue. For example, the distal end 17 of the implant disengagement passage 18 can be arranged (eg, pushed) against a wall of the sleeve, sandwiching the sleeve against the heart tissue.

[0471] For some applications, the placement of the distal end 17 of the implant disengagement channel 18 against the cardiac tissue (via the sleeve wall) stabilizes the distal end during deployment and anchoring of each anchor 32, thereby facilitating anchoring. For some applications, the pushing of the distal end 17 against the cardiac tissue (via the sleeve wall) temporarily deforms the cardiac tissue at the contact site. This deformation can facilitate identification of the contact site using imaging techniques (e.g., by identifying deformation of the boundary between cardiac tissue and blood), which can facilitate correct positioning of the anchor.

[0472] That is, generally, the entire circular surface of the distal end 17 of the implant disengagement channel 18 is arranged to contact the wall of the flexible sleeve 26 arranged against the surface of the heart tissue. As shown, the distal end 17 is the lowermost circular tip of the implant disengagement channel 18 and defines the distal opening of the implant disengagement channel 18. In a configuration where the implant disengagement channel 18 is positioned to sandwich a portion of the flexible sleeve 26 against the annulus 240, the distal end 17 is arranged parallel to the flat surface 255 of the tissue of the annulus.

[0473] like Figure 3C As shown, the end wall 251 is aligned against the tissue of the annulus 240 in such a manner that the surface of the end wall 251 is arranged parallel to the flat surface of the tissue of the annulus 240. In addition, the distal end 17 of the implant disengagement passage 18 causes the end wall 251 to lie flat against the tissue of the annulus 240 in such a manner that the implant disengagement passage 18 sandwiches the end wall 251 between (1) the distal end 17 of the passage and (2) the portion of the tissue of the annulus 240 at the flat surface where the first anchor 32 is implanted. In this manner, the end wall 251 lies flat against the tissue of the annulus 240 parallel to the flat surface, while at least the distal portion of the side wall 253 is arranged substantially perpendicularly relative to the portion of the tissue of the annulus 240 at the flat surface where the first anchor 32 is implanted.

[0474] As shown, the anchor 32 is implanted using the implant disengagement channel 18 and manipulator 61 contained within the flexible sleeve 26 of the annuloplasty structure 222 , with at least a portion (eg, a proximal portion) of the annuloplasty ring structure 222 contained within the peripheral guide catheter 14 .

[0475] Reference Figure 2 , 3C -D and 4A-B. After the first tissue anchor is deployed, the distal portion of the flexible sleeve 26 is disengaged from a portion of the implant disengagement channel 18. To disengage the portion of the flexible sleeve 26 from the outer surface of the implant disengagement channel 18, (1) the implant disengagement channel 18 is pulled proximally while (2) the reference force tube 19 is held in place in the following manner: the distal end of the reference force tube 19 provides a reference force to the flexible sleeve 26 to facilitate the disengagement of successive portions of the flexible sleeve 26 from around the implant disengagement channel 18. To disengage the flexible sleeve 26 from the outer surface of the implant disengagement channel 18, (1) the implant disengagement channel 18 is pulled proximally while (2) the reference force tube 19 is held in place. The indicator 2120 on the handle 126 provides an indication of how much of the implant disengagement channel 18 has been withdrawn from the flexible sleeve 26 (i.e., how much of the delivery tool has been disengaged from the flexible sleeve 26 and how much of the sleeve has been pushed out of the implant disengagement channel 18 and toward the tissue). The proximal end of the implant disengagement channel 18 is coupled to the knob 94 ( Figure 2 ), the knob 94 adjusts the axial position of the implant disengagement channel 18 proximally and distally relative to the reference force tube 19 and the flexible sleeve 26. Figure 3D As shown, after successive partial releases of the flexible sleeve 26 , the manipulator 61 is repositioned along the annulus 240 to another site selected for deployment of a second anchor 32 .

[0476] Figure 4A and 4B is to show the respective applications according to the present invention Figure 3C The status and Figure 3D Schematic diagram of the steps between the states shown. Figure 4A and 4B Each step C in Figure 3D The states shown are generally equivalent states.

[0477] For some applications, Figure 4A As shown, the anchor driver 36 is decoupled from the anchor 32 and retracted through the implant decoupling passage 18 before retracting the implant decoupling passage 18 through the flexible sleeve 26 and repositioning the implant decoupling passage 18 .

[0478] For some applications, Figure 4BAs shown, the anchor driver 36 remains coupled to the anchor 32 during the retraction of the implant disengagement passage 18 through the flexible sleeve 26. For some such applications, the anchor driver 36 provides a reference force (e.g., a reference force in the distal direction) that keeps the anchor 32 and the anchoring portion of the flexible sleeve 26 in place when the implant disengagement passage 18 is retracted, e.g., reducing the pulling force on the anchor 32.

[0479] Thus, the following method is described, comprising: (1) percutaneously advancing the annuloplasty ring structure 222 toward tissue of the subject while the distal portion of the implant disengagement channel 18 is disposed within the cavity defined by the flexible sleeve 26 such that the distal opening of the channel is disposed at the first portion of the sleeve; (2) anchoring the first portion of the sleeve to the tissue by driving the tissue coupling element 60 of the first anchor 32 through the distal opening of the channel, through the sleeve, and into the tissue using the anchor driver 36; (3) subsequently, while providing a distally directed reference force to the first anchor 32 via the driver 36, proximally withdrawing the distal portion of the implant disengagement channel 18 such that the distal opening of the channel is disposed at the second portion of the sleeve; (4) subsequently, typically withdrawing the driver 36 proximally of the channel; and (5) subsequently, anchoring the second portion of the sleeve to the tissue by driving the tissue coupling element 60 of the second anchor 32 through the distal opening of the channel, through the flexible sleeve 26, and into the tissue.

[0480] Reference Figure 2 , 3D and 4A-B. This repositioning of the manipulator 61 is achieved by performing one or more of the following:

[0481] (1) manipulating the distal portion 112 of the outer catheter 12 in a first manipulation plane (e.g., via a manipulation knob 210 of the handle 22) in a manner that causes the portion 112 to bend,

[0482] (2) manipulating the distal end 114 of the guide catheter 14 in a second manipulation plane in the manner of the portion 112 (e.g., via a manipulation knob 214 of the handle 24),

[0483] (3) axially moving the guide catheter 14 relative to the outer catheter 12 via the knob 216,

[0484] (4) axially moving the base support handles 22 and 24 to move the outer catheter 12 and the guide catheter 14,

[0485] (5) By sliding the fixing member 93 along the track 90, the reference force tube 19 and the flexible sleeve 26 are moved axially.

[0486] (6) By actuating the knob 94, the implant disengagement channel 18 is moved relative to the reference force tube 19.

[0487] Typically, the first tissue anchor is deployed farthest in the sleeve (generally at or within a few millimeters of the distal tip of the sleeve), and each subsequent anchor is deployed more proximally, so that the sleeve is gradually decoupled from the implant decoupling channel 18 of the manipulator 61 in the distal direction during the anchoring procedure (i.e., the implant decoupling channel 18 is withdrawn from the flexible sleeve 26, and the handle 126 is moved distally, thereby retracting the tool so that the successive proximal flexible sleeves 26 are ready for implantation of subsequent anchors). The first deployed anchor 32 holds the anchoring end of the flexible sleeve 26 in place so that the sleeve is pulled from the site of the first tissue anchor toward the site of the second tissue anchor. As the flexible sleeve 26 is pulled and decoupled from the implant decoupling channel 18, the distal portion 257 of the flexible sleeve 26 (i.e., the portion of the sleeve proximal to the end wall 251) is positioned near the tissue of the annulus 240.

[0488] Figure 3D The distal portion 257 of the flexible sleeve 26 (i.e., the portion of the sleeve proximal to the end wall 251) is shown having been detached from a portion of the implant detachment passage 18 by proximally retracting the implant detachment passage 18. Depending on the tension applied between the first and second tissue anchor sites, the portion of the flexible sleeve 26 therebetween may maintain a tubular shape, or may flatten.

[0489] Figure 3E A second tissue anchor 32 (shown as second tissue anchor 32b) is shown deployed through a portion of the side wall 253 of the flexible sleeve 26. The first anchor 32 deployed through the end wall 251 is labeled as anchor 32a. The manipulator 61 deploys the second tissue anchor by driving the anchor through and through the wall of the flexible sleeve 26 and into the heart tissue at a second location.

[0490] As shown, while at least a portion (eg, a proximal portion) of the annuloplasty ring structure 222 is contained within the peripheral guide catheter 14 , the anchor 32 b is implanted using the implant decoupling channel 18 and manipulator 61 contained within the flexible sleeve 26 of the annuloplasty ring structure 222 .

[0491] As described above, each of the anchors 32a and 32b is deployed from the distal end of the manipulator 61, which is positioned so that the central longitudinal axis passing through the distal end of the manipulator 61 forms an angle with the surface of the heart tissue, the angle being between about 20 and 90 degrees, for example, between 45 and 90 degrees, such as between about 75 and 90 degrees, such as about 90 degrees. Generally, the anchor 32 is deployed from the distal end of the manipulator 61 into the atrial surface of the heart tissue in a direction parallel to the central longitudinal axis passing through the distal end of the manipulator 61. This angle is generally provided and / or maintained by the implant disassembly channel 18 being more rigid than the flexible sleeve 26. The distal end 17 of the implant disassembly channel 18 is generally brought close to the surface of the heart tissue (and the wall of the flexible sleeve 26 disposed close to the surface of the heart tissue) so that the anchor 32b is barely exposed from the implant disassembly channel 18 before penetrating the sleeve and tissue. For example, the distal end 17 of the implant disengagement passage 18 can be arranged (eg, pushed) against a wall of the sleeve, sandwiching the sleeve against the heart tissue.

[0492] like Figure 3D -E, a portion of the side wall of the flexible sleeve 26 is aligned against the tissue in such a manner that the surface of the portion of the side wall is arranged parallel to the flat surface of the tissue. Additionally, the distal end 17 of the implant disengagement channel 18 causes the portion of the side wall to lie flat against the tissue of the annulus 240 in such a manner that the implant disengagement channel 18 clamps the portion of the side wall between (1) the distal end 17 of the implant disengagement channel and (2) the portion of the tissue of the annulus 240 at the flat surface where the second tissue anchor 32b is implanted. In this manner, the anchored portion of the side wall lies flat against the tissue of the annulus 240 (parallel to its flat surface), while the remainder of the tubular side wall is arranged substantially perpendicularly relative to the portion of the tissue where the second tissue anchor 32b is implanted.

[0493] Note that the first and second tissue anchors 32a and 32b extend in substantially the same direction and into a common substantially flat annular surface, although the first tissue anchor 32a is deployed through the end wall 251 of the flexible sleeve 26 and the tissue anchor 32b is deployed through the sleeve's side wall 253. For some applications, the anchors 32a and 32b are arranged at an angle relative to each other that is between 0 and 45 degrees, e.g., between 0 and 30 degrees, e.g., between 0 and 20 degrees.

[0494] For some applications, the maximum distance L10 between the anchor points of the first tissue anchor 32a and the second tissue anchor 32b is provided by the length of the flexible sleeve 26 that has been disassociated from the portion of the implant disassociating channel 18 (e.g., the distance of the implant disassociating channel 18 that has been withdrawn from the flexible sleeve 26, e.g., between 3 and 15 mm, e.g., 8 mm). That is, for some applications, the second tissue anchor 32b can be arranged at any position within a circle with a radius equal to L10 centered on the first tissue anchor (e.g., indicated by arc 1928). For some such applications, the flexible sleeve 26 thus acts as a restraining member (e.g., a restraint) for facilitating the positioning of the second tissue anchor 32b. The distance L10 is thereby set by the operator withdrawing the implant disassociating channel 18 from the flexible sleeve 26 by a specific distance.

[0495] Figure 3F The full length of the flexible sleeve 26 is shown anchored to the annulus 240 via a plurality of anchors 32 as described above. A deployment manipulator (i.e., described herein but not shown) is shown. Figure 3F The manipulator 61 in the annulus is repositioned along the valve annulus to additional locations where respective anchors are deployed until the last anchor is deployed near the right trigone 244 (or the left trigone 242 if anchoring begins in the right trigone). Optionally, the last anchor is not deployed near the trigone, but rather at another location near the mitral valve, such as near the anterior or posterior commissure. The system 10 is then removed, leaving behind the annuloplasty ring structure 222 and the guide member 86 coupled thereto.

[0496] Figure 3GAn adjustment tool 87 is shown passed over and advanced along the guide member 86. The adjustment tool 87 generally comprises a rotation tool and is configured to actuate (e.g., rotate) the adjustment mechanism 40 to tension the contraction member 226 and thereby contract the flexible sleeve 26, as described above. Generally, the adjustment mechanism 40 comprises a housing that houses a reel, i.e., a rotatable structure, to which a first end of the contraction member 226 is coupled. Generally, the reel is configured to adjust the circumference of the annuloplasty ring structure 222 by adjusting the degree of tension of the contraction member 226 coupled to the reel at a first portion of the member 226. The contraction member 226 extends along the flexible sleeve 26, and a second portion (i.e., a free end) of the contraction member 226 is coupled to a portion of the flexible sleeve 26 such that upon rotation of the reel in a first rotational direction, the contraction member is pulled toward the adjustment mechanism 40 to contract the annuloplasty ring structure 222. Note that contraction of the annuloplasty ring structure 222 is reversible. That is, rotating the reel in a second rotational direction (opposite to the first rotational direction for contracting the annuloplasty structure) causes a portion of the contraction member 226 to unwind from around the reel. The portion of the contraction member 226 unwinds from around the reel and thus is sent back into the flexible sleeve 26 of the annuloplasty ring structure 222, thereby slackening the remainder of the contraction member 226 disposed within the sleeve. Accordingly, the annuloplasty structure gradually relaxes and expands (i.e., relative to its contracted state prior to unwinding).

[0497] The adjustment mechanism 40 generally includes a locking mechanism that prevents the adjustment mechanism from being actuated (eg, the spool is rotated) after the retraction member 226 is tightened. For example, the locking technique described with reference to FIG. 4 of US Patent 8,241,351 to Cabiri may be employed.

[0498] The tool 87 is used to rotate the reel of the adjustment mechanism 40 to adjust the retraction member 226 (not shown). Figure 3G The annuloplasty ring structure 222 is tightened by adjusting the tension level of the annuloplasty ring structure 222. After the desired adjustment level of the annuloplasty ring structure 222 is achieved - for example, by monitoring the degree of valvular regurgitation using echocardiography (such as Doppler echocardiography and / or fluoroscopy) - the adjustment tool 87 and guide member 86 are removed from the heart. For some applications, the distal portion of the guide member 86 may remain in the heart of the subject and the proximal end may be accessed outside the body, for example, using a port. For such applications, the adjustment mechanism 40 may be accessed at a later stage after the initial implantation and adjustment of the annuloplasty ring structure 222 (e.g., see FIG. 1 ). Figures 16A-18K described above).

[0499] Optionally, the annuloplasty ring structure 222 is implanted through a right or left thoracotomy (appropriately modified according to actual conditions).

[0500] Reference again Figure 3A -G, and also refer to Figure 5A -B, Figure 5A -B is a schematic diagram of a technique for the protruding portion 261 of the flexible sleeve 26 according to some applications of the present invention. For some applications of the present invention, after the flexible sleeve 26 is implanted along the valve ring, the protruding portion 261 of the sleeve 26 may be present at the proximal portion of the sleeve. For some such applications, the protruding portion 261 may be anchored to the atrial surface, such as the atrial wall, using an anchor delivered through the lumen of the flexible sleeve 26, as described above (with appropriate changes according to actual conditions), such as Figure 5A shown.

[0501] Alternatively or additionally, the overhanging portion 261 may be anchored to the atrial surface using anchors that are driven laterally through the flexible sleeve 26 from the outside of the sleeve so that each anchor passes through the side wall of the sleeve twice (e.g., on opposite sides of the sleeve lumen), such as Figure 5B Thus, a method is described that includes: (1) percutaneously advancing annuloplasty ring structure 222 toward tissue of a subject while a distal portion of implant disengagement channel 18 is disposed within a lumen of flexible sleeve 26 such that a distal opening of the channel is disposed at a first portion of the sleeve; (2) anchoring the first portion of the sleeve to a first tissue site by driving a tissue coupling element 60 of a first anchor 32 through the distal opening of the channel, through a first portion of the sleeve (e.g., through end wall 251 or side wall 253), and into a first tissue site using an anchor driver 36; (3) pressing a second portion of the sleeve (i.e., protruding portion 261) toward a second tissue site; and (4) anchoring the second portion of the sleeve to a second tissue site by driving a tissue coupling element 60 of a second anchor 32 from outside the lumen through an opposite side of a side wall of the second portion of the sleeve and into the second tissue site.

[0502] For some applications, when the second portion (ie, the protruding portion) of the sleeve is pressed against a second tissue site (eg, an atrial wall), opposing sides of sidewall 253 at the second portion of the sleeve contact each other.

[0503] Reference again Figure 3A -G. For anatomical reasons, a transluminal (e.g., transfemoral) approach to the mitral valve via a transseptal puncture generally provides more direct and / or easier access to the anterior commissure region (e.g., including the left trigone 242) than to the posterior commissure region (e.g., including the right trigone 244). Therefore, positioning and anchoring the distal wall 251 of the flexible sleeve 26 near the left trigone may be beneficial; positioning of a first anchor point of the annuloplasty ring structure 222 may be more difficult than positioning of subsequent anchor points (e.g., due to the guidance provided by the flexible sleeve 26; Figure 3E For this same accessibility reason, delivery of adjustment tool 87 to the anterior commissure region (eg, Figure 3G) may also be beneficial.

[0504] The system 10 (e.g., the annuloplasty ring structure 222 thereof) is configured to facilitate the exploitation of these two benefits: with the adjustment mechanism 40 disposed at the distal end of the flexible sleeve 26 and movable away from the longitudinal axis of the sleeve, (1) the first tissue anchor can be driven through the end wall 251 into the anterior commissure region even though the adjustment mechanism has been previously obstructively positioned, and (2) an adjustment tool can be delivered to the anterior commissure region because the adjustment mechanism is disposed in that region.

[0505] Now for further reference Fig. 6A 7A-B and 7A-B are schematic diagrams of manipulating the outer catheter 12 and the guide catheter 14 according to respective applications of the present invention. As described above, the distal end 112 of the outer catheter 12 is manipulatable in a first manipulation plane, and the distal end 114 of the guide catheter 14 is manipulatable in a second manipulation plane, the second manipulation plane being generally perpendicular to the first manipulation plane. As also described above, generally (i) the outer catheter 12 is manipulated in a manipulation plane parallel to the annular plane of the valve (e.g., Fig. 6A ), and (ii) the guide catheter 14 is manipulated downward and toward the annulus of the valve (e.g., as Figure 6B 104 ), such that an angle α_1 is formed between (i) the annular plane 241, and (ii) the exit direction 105 of the guide catheter 14 from the distal end 104. (The exit direction 105 is generally colinear with the central longitudinal axis passing through the distal end of the manipulator 61 and / or the central longitudinal axis of the tissue coupling element 60 of the anchor 32.) Generally, the angle α_1 is greater than the angle α_3 formed between the plane 241 and the exit direction 103 from the distal end 102 of the outer catheter 12.

[0506] Alternatively, the outer catheter 12 can be manipulated in different manipulation planes so that the guide catheter 14 can approach the tissue from different angles, so that the anchor 32 can penetrate the tissue at different invasion angles. For example, and as shown in FIG7 , the outer catheter 12 can be manipulated downward and toward the annulus of the valve, and the guide catheter 14 can be manipulated so that the angle α_2 (formed between the annulus plane and the central longitudinal axis passing through the distal end of the manipulator 61) is less than the angle α_1. For this application, the angle α_2 is generally less than the angle α_4 formed between the plane 241 and the exit direction 103.

[0507] Reference Fig. 8A -B, 9, 10A-C, 11 and 12A-B, which are schematic diagrams of tissue anchors according to some applications of the present invention and the use of tissue anchors for implanting an annuloplasty ring structure 222.

[0508] Fig. 8AThe tissue anchor 32 described above is shown. Fig. 8A As shown, the tissue coupling element 60 is generally helical and has a central longitudinal axis 33 (which is the rotation axis of the element 60 when the element 60 is helical). The tool engagement head 62 has a width d1, and the tissue coupling element 60 has a width (e.g., a helical diameter) d2, which is about the same as the width d1 for some applications. Each of the width d1 and the width d2 is less than the lumen diameter of the implant disassembly passage 18, thereby facilitating the delivery of the anchor 32 through the implant disassembly passage 18 as described above. The maximum lateral width of the anchor 32 is less than the lumen diameter of the implant disassembly passage 18.

[0509] The width d2 is generally between 0.1 and 0.5 cm (e.g., 0.25 cm). The helical length d7 of the element 60 is generally 0.3-0.9 cm, such as 0.3-0.65 cm (e.g., 0.55 cm), and the helical pitch d8 is generally 0.05-0.3 cm (e.g., 0.12 cm). Typically, the helical wire thickness d9 of the element 60 is 0.02-0.1 cm (e.g., 0.05 cm).

[0510] Figure 8B Shown is a tissue anchor 332, which is generally consistent with the tissue anchor 32 except for the marked parts. The anchor 332 includes a tool engagement head 362, which is generally (but not necessarily) consistent with the head 62 of the anchor 32. The anchor 332 further includes a tissue coupling element 360 and has a central longitudinal axis 333. The width d3 of the head 362 is generally less than the cavity diameter of the implant disassembly channel 18, and the width d4 of the tissue coupling element 360 is greater than the cavity diameter of the channel (therefore greater than the width d2). For example, the widths d1, d2 and d3 and the cavity diameter of the implant disassembly channel 18 can each be 2-3mm, and the width d4 (generally the maximum transverse width of the anchor 332) can be 3-4mm (e.g., about 3.4mm). Therefore, the tissue coupling element 360 generally protrudes radially outward from the longitudinal axis 333 by a distance d5 than the head 362. Optionally, the width d3 can also be greater than the cavity diameter of the implant disassembly channel 18.

[0511] The greater width of element 360 compared to element 60 provides increased anchoring strength. It is contemplated that for some applications, this increased anchoring strength is particularly useful for a first anchor (e.g., an anchor that penetrates end wall 251) used to anchor the annuloplasty ring structure 222 due to increased forces applied to the anchor compared to, for example, anchors further along flexible sleeve 26. Because width d4 is greater than the lumen diameter of implant disengagement passage 18, anchor 332 cannot be advanced through implant disengagement passage 18 in the same manner as anchor 32. Figure 9-12BA technical approach to anchoring the annuloplasty ring structure 222 (eg, the distal end of the flexible sleeve 26) using an anchor 332 is shown.

[0512] Generally, the spiral wire thickness of tissue coupling element 360 is generally the same as thickness d9. Tissue coupling element 360 generally has a spiral length generally the same as length d7. For some applications, the spiral pitch d10 of element 360 is different from pitch d8. For example, pitch d10 may be less than pitch d8, thereby keeping the spiral length of element 360 generally the same as length d7. For some applications, the spiral angle α_6 (angle between spiral and its central longitudinal axis) of element 360 is different from the spiral angle α_5 of element 60. For example, angle α_6 may be greater than angle α_5, thereby keeping the spiral length of element 360 generally the same as length d7.

[0513] When the implant disassembly passage 18 is loaded into the sleeve cavity, at least the tissue coupling element 360 of the anchor 332 is arranged outside the distal end 17 of the implant disassembly passage 18. For example, the deployment element 38 of the anchor driver 36 can be advanced through the implant disassembly passage 18 without connecting the anchor, and then connected to the head 362 of the anchor 332. The assembly including the element 38 (and optionally the head 362) can then be retracted into the implant disassembly passage 18 before the passage, the anchor 332 and the driver 36 are advanced together into the flexible sleeve 26. For some applications, the assembly is advanced through the guide catheter 14 (and to its distal end) before being advanced into the flexible sleeve 26. Therefore, the tissue coupling element 360 does not need to pass through the implant disassembly passage 18, thereby facilitating the application of the anchor 332.

[0514] For some applications, Figure 9-10C As shown, during advancement of the annuloplasty ring structure 222, the tissue coupling element 360 is disposed (i) outside the distal end 17 of the implant disengagement passage 18, and (ii) inside the lumen of the flexible sleeve 26. This can be seen by comparing Fig. 9 and Figure 1 Come to understand. Fig. 10A The steps shown in -C generally correspond to Figure 3A -C, but the element 360 is arranged outside the distal end 17 of the implant disengagement channel 18 and inside the cavity of the flexible sleeve 26. After the anchor 332 is anchored ( Fig. 10C ), a plurality of anchoring members 32 are used to anchor the rest of the annuloplasty ring structure 222, as described above (appropriate changes may be made based on actual conditions).

[0515] For some applications, Figure 11-12BAs shown, during advancement of the annuloplasty ring structure 222, the tissue coupling element 360 is disposed (i) outside the distal end 17 of the implant disengagement passage 18, and (ii) outside the flexible sleeve 26, e.g., having been driven through the flexible sleeve 26 (e.g., the end wall 251 thereof). This can be seen by comparing Fig.11 and Fig. 9 (and / or Figure 1 ) to understand. Fig. 12A The steps shown in -B generally correspond to Fig. 10B -C, but the element 360 is arranged outside the flexible sleeve 26. Because the element 360 protrudes through the flexible sleeve 26 when the element 360 contacts the tissue, the sleeve is not pressed against the tissue before the anchor 332 is driven, and a gap 366 exists between the tissue and the sleeve. The tissue anchor 332 generally has a straight and / or central trunk portion 364, which facilitates the subsequent closing of this gap by allowing the anchor to rotate freely within the sleeve, for example, as known in the field of captive screws. This feature is described in more detail in WO 2014 / 064694 to Sheps et al., which is incorporated herein by reference.

[0516] refer to Fig.13A -D and 14A-F, which are schematic diagrams of a system 400 including a tissue anchor 402, an anchor driver 404, and a lance 406, and techniques for use with the system, according to some applications of the present invention.

[0517] Except where noted, the anchor driver 404 is generally consistent with the anchor driver 36 described herein, and can generally replace the anchor driver 36, (with appropriate changes according to actual circumstances). Except where noted, the tissue anchor 402 is generally consistent with the tissue anchor 32 described herein, and can replace the tissue anchor 32, (with appropriate changes according to actual circumstances). The anchor driver 404 includes an elongated shaft 408 (generally tubular) and a deployment manipulator 410 connected to the distal end of the shaft.

[0518] System 400 is shown for anchoring annuloplasty ring structure 222, but it is noted that the scope of the present invention includes the use of system 400 in other situations where percutaneous delivery of tissue anchors is desired. Tissue anchor 402 includes a tissue coupling element that is attached to the annuloplasty ring structure 222. Figures 13A-14F It is shown as element 60, but it may include different tissue connecting elements.

[0519] Lance 406 serves two purposes: (1) to facilitate reversible locking of driver 404 to anchor 402, and (2) to stabilize system 400 at tissue prior to driving anchor 402 into tissue.

[0520] The distal tip of lance 406 extends distally beyond the distal tip of tissue coupling element 60 (e.g., Fig.13A ), the system 400 is advanced so that the spear engages the tissue in front of the element 60 ( Fig.14A ). The spear 406 penetrates the tissue, thereby stabilizing the system 400 at the tissue. Fig.14A and Fig. 14B , for some applications, the system 400 is used in combination with a catheter system that facilitates pivoting (i.e., deflection) of the system 400 about the site at which the spear 406 penetrates the tissue. For example, such a catheter system may include a guide catheter 14 (as shown), an outer catheter 12, and / or other elements of the system 10. It is contemplated that this facilitates the separation between (i) properly positioning the anchor 402 at the anchor site and (ii) properly orienting the anchor relative to the tissue at the anchor site. That is, the spear 406 may penetrate the tissue at the proper location but not at the proper orientation (e.g., angle) ( Fig.14A ), and the system 400 can then be deflected about this position (e.g., using the spear as a pivot) to achieve the proper orientation (e.g., the proper angle of invasion of the anchor 402) ( Fig. 14B ).

[0521] The anchor 402 is typically driven at least partway into the tissue before the spear 406 is partially retracted. Fig. 14C -D). Fig. 13B The lance 406 is shown in such a partially retracted position. The presence of the lance 406 in the deployment manipulator 410 keeps the deployment manipulator locked to the anchor 402 (e.g., to its tool engaging head 412). For example, and as shown, the deployment manipulator 410 may include one or more detents 414 that are maintained in a locked position (e.g., radially outward) by the lance 406. Fig. 13B The partial retraction of the lance 406 shown does not remove the lance from the deployment manipulator 410 , so the manipulator remains locked to the anchor 402 .

[0522] Fig.14D The anchor 402 is shown fully anchored to the tissue and the lance 406 is partially retracted. After anchoring, the lance 406 is further retracted, thereby unlocking the deployment manipulator 410 from the anchor 402 ( Fig.14E ) - for example, due to the corresponding radial inward movement of the pawl 414, such as Fig. 13C Then, the driver 404 can be disconnected from the anchor 402 ( Fig.14F and 13D ).

[0523] Thus, a device is described, comprising (1) an anchor comprising (a) an anchor head, and (b) a tissue engaging member coupled to the anchor head, extending distally away from the anchor head to a distal tip of the tissue engaging member, and configured to anchor the anchor to tissue; and (2) an anchor driver comprising: (a) a longitudinal shaft having a flexible distal portion and a distal end, (b) a deployment element at the distal end of the shaft, the deployment element being reversibly lockable to the anchor head and reversibly movable between: (a) a longitudinal shaft having a flexible distal portion and a distal end, and (b) a deployment element at the distal end of the shaft, the deployment element being reversibly lockable to the anchor head and reversibly movable between: i) a locked state - maintaining the lock between the deployment element and the anchor head, and (ii) an unlocked state - unlocking the deployment element from the anchor head, and (c) a tissue piercing lance that can reversibly move between: an extended state - in which (i) the lance extends distally from the axis, (ii) when the deployment element is locked to the anchor head, the lance extends distally beyond the distal tip of the anchor, and (iii) the lance maintains the deployment element in the locked state, and a retracted state - in which the deployment element automatically moves to the unlocked state.

[0524] Thus, an apparatus is also described, comprising (1) a percutaneous catheter; (2) an implant sized to be advanced into a subject via the catheter; (3) an anchor delivery channel shaped to define a lumen therethrough, the lumen having a diameter and sized to be disposed within the catheter; (4) at least one anchor comprising an anchor head coupled to a tissue coupling element, the anchor head defining a hole therethrough, and (5) an anchor driver, the anchor driver (i) comprising a trunk and a driver head coupled to a distal end of the trunk, the driver head being reversibly movable. connected to the anchor head, (ii) configured to advance the anchor through the channel cavity when the drive head is connected to the anchor head, (iii) further including a lance that is reversibly extendable relative to the drive head so that when the drive head is connected to the anchor head, extension of the lance causes the lance to slide through the hole so that the tip of the lance is disposed distally beyond the distal tip of the tissue engaging element, and (iv) configured to drive the tip of the lance through a portion of the implant and into the tissue of the subject, and drive the tissue engaging element of the anchor through a portion of the implant and into the tissue of the subject independent of the driving of the tip of the lance.

[0525] Thus, a device is also described, which includes (1) an anchor member, the anchor member including (i) an anchor head having a proximal side and a distal side and defining an aperture extending from the proximal side to the distal side, (ii) a tissue engaging member coupled to the anchor head, extending distally away from the anchor head to a distal tip of the tissue engaging member, and configured to anchor the anchor member to tissue; (2) an anchor member driver, the anchor member driver including (i) a longitudinal shaft having a flexible distal portion and a distal end, (ii) a tissue piercing lance that is reversibly extendable from the axial distal side, and (iii) a deployment element coupled to the shaft distal end and reversibly movable at a position where extension of the lance from the axial distal side causes the lance to pass through the aperture and move past the distal tip of the anchor member. inversely connected to the anchor head; and (3) a catheter system comprising (i) a catheter through which an anchor driver can be advanced in vivo, (a) at which time a deployment element is connected to the anchor head, and (b) such that a distal portion of the shaft extends distally out of the catheter and has a distal segment that is deflectable in vivo relative to another segment of the catheter proximally adjacent to the distal segment, and (ii) an in vitro controller configured to, when the distal portion of the shaft extends distally out of the catheter and a lance extends distally from the shaft and is disposed in tissue, cause the distal segment to deflect relative to the other segments so that the distal portion of the shaft deflects relative to another portion of the shaft proximally adjacent to the distal portion, the anchor driver being configured to drive the tissue engaging member into the tissue when the distal portion of the shaft deflects relative to the other portion of the shaft.

[0526] Thus, a method is also described, which includes (1) advancing a distal end of an anchor driver, including a shaft, a tissue piercing lance, and a deployment element, through a catheter and toward tissue of a subject; (2) thereafter, piercing the tissue with the lance; (3) deflecting the distal portion of the shaft relative to another portion of the shaft immediately proximal to the distal portion by moving a distal segment of the catheter while at least some of the lances are disposed within the tissue; and (4) using the anchor driver to drive a tissue engaging member of the anchor into the tissue while (i) the distal portion of the shaft is deflected relative to the other portion of the shaft and (ii) the deployment element is locked to the anchor head.

[0527] refer to Fig.15A-B, these are schematic diagrams of implants 422a and 422b according to some applications of the present invention, each of which includes a contraction wire. Implants 422a and 422b each include a valvuloplasty structure, the valvuloplasty structure including (1) a sleeve having a first end and a second end, a bearing site, and including a sidewall defining a cavity from the first end to the second end, (2) an adjustment mechanism 40, and (3) a contraction member, the contraction member (a) having a first end coupled to the adjustment mechanism, (b) having a first portion extending from the adjustment mechanism along the sleeve toward the second end to the bearing site, and (c) having a second portion extending from the bearing site back toward the adjustment mechanism and the first end, the adjustment mechanism being configured to reduce the length of the sleeve between the first end and the second end by pulling on the first portion of the contraction member so that the second portion of the contraction member progressively slides past the bearing site.

[0528] Generally, except where noted, implants 422a and 422b are identical to annuloplasty ring structure 222 and can be used in the techniques described herein in place of annuloplasty ring structure 222. Similarly, the sleeves of each implant are generally identical to flexible sleeve 26 (with appropriate variations as required), and reference numeral 26 is also used for these sleeves.

[0529] The implant 422a includes a contraction member 426a. The first end of the contraction member 426a is coupled to the adjustment mechanism 40. The first portion 424a of the contraction member 426a extends from the adjustment mechanism 40 through the lumen of the flexible sleeve 26 toward the proximal end 252 of the sleeve to the bearing site 430. The second portion 428a of the contraction member 426a extends from the bearing site 430 back toward the adjustment mechanism 40 and the distal end of the sleeve (e.g., end wall 251), interlacing through the side wall 253 of the flexible sleeve 26.

[0530] Implant 422b includes a contraction member 426b. A first end of contraction member 426b is coupled to adjustment mechanism 40. A first portion 424b of contraction member 426a extends from adjustment mechanism 40 toward proximal end 252 of flexible sleeve 26, weaving through sidewall 253, to bearing site 430. A second portion 428b of contraction member 426a extends from bearing site 430 back toward adjustment mechanism 40 and the distal end of the sleeve (e.g., end wall 251), weaving through sidewall 253 of flexible sleeve 26. Implant 422b is generally identical to implant 422a, except that a first portion of contraction member 426b also weaves through sidewall 253 of flexible sleeve 26.

[0531] With respect to each of implants 422a and 422b, as adjustment mechanism 40 stretches the contraction member, the second portion of the contraction member progressively slides over (e.g., passes through) bearing site 430. (This generally occurs when bearing site 430 moves toward adjustment mechanism 40 due to implant contraction.) Generally, and as shown, bearing site 430 is defined by a hole in flexible sleeve 26, reinforced by an eyelet (e.g., a metal ring, such as a grommet). For some applications, bearing site 430 may include a different bearing, such as a wheel (e.g., a pulley). Note that for both implants 422a and 422b, the first portion and the second portion of the contraction member are shortened during contraction of flexible sleeve 26.

[0532] Typically, for implants 422a and 422b, the first portion of the contraction member enters the flexible sleeve 26 via a hole in the sleeve, reinforced by an eyelet (e.g., a metal ring, such as a grommet). This hole can also serve as a bearing site 431 through which the first portion of the contraction member slides when the adjustment mechanism 40 stretches the contraction member.

[0533] Typically, the second end 429 of the retraction member (ie, the end not coupled to the adjustment mechanism 40) is fixedly coupled to the sleeve (eg, using a crimp bead, as shown).

[0534] refer to Fig.16A -B, 17A-C, and 18A-K, which are schematic diagrams of a system 440 for docking and adjusting an adjustment mechanism of a percutaneously implantable implant and techniques therefor, according to some applications of the present invention.

[0535] An apparatus is described that includes: (1) a percutaneously implantable implant (e.g., an annuloplasty ring structure 222 that includes a flexible sleeve 26); (2) an adjustment device 442 that includes (i) an adjustment mechanism (e.g., mechanism 40) coupled to the implant and configured to change a size of the implant upon actuation of the adjustment mechanism; and (ii) a lock 444 that (a) has a locked state in which the lock inhibits actuation of the adjustment mechanism, (b) has an unlocked state in which the adjustment mechanism is actuatable, and (c) can be reversibly engaged in the lock. 446, which: (i) is coupled to the guide member, (ii) includes a fastener 448 that couples the connector to the adjustment device and can be disconnected from the adjustment device in vivo, (iii) is configured to be delivered percutaneously when coupled to the adjustment device, and (iv) includes an unlocking mechanism 450 that is configured such that, when the connector is coupled to the adjustment device, actuation of the unlocking mechanism causes the lock to move between the locked state and the unlocked state.

[0536] Fig.16A -B is a schematic diagram of a connector 446 coupled to an adjustment device 442 according to some applications of the present invention. As described below, the connector 446 is generally coupled to the adjustment device 442 before the implant is delivered and implanted (e.g., the connector is pre-coupled to the device 442, or is coupled to the device 442 by a physician before implantation), and the implant is delivered and implanted with the connector 446 coupled to the device 442. Fig.16A An exploded view of adjustment device 442 and connector 446 is shown, and Fig. 16B Assembly view showing the connector connected to the adjustment device.

[0537] The connector 446 includes a body 452 (i.e., a main body portion) coupled to the fastener 448. Generally, the unlocking mechanism 450 includes a pin disposed in a channel, and actuation of the unlocking mechanism to unlock the lock 444 of the adjustment device 442 (described below) includes sliding of the pin within the channel. For some applications, and as shown, at least a portion of this channel is defined by the fastener 448. For some applications, and as shown, at least a portion of this channel is defined by the body 452. The body 452 generally includes a side opening 474 through which the appendage 451 of the pin protrudes.

[0538] The lock 444 includes a depressible portion 443 that defines or is coupled to a pawl 445 , and an unlocking mechanism 450 depresses on the depressible portion, thereby moving the pawl to unlock, as described below.

[0539] The body 452 is shaped so that at least the cross-sectional outer shape of the proximal (upper, as shown) portion of the body is non-circular. This facilitates application of torque to the body 452 to uncouple (e.g., untwist) the joint 446 from the adjustment device 442, as described below.

[0540] For some applications, and as shown, fastener 448 is shaped to define threads that screw into corresponding threads defined by adjustment device 442 , and connector 446 is decoupled from adjustment device 442 by unscrewing.

[0541] Fig.17A-C is a schematic diagram of an adjustment tool 460 according to some applications of the present invention. The adjustment tool 460 is percutaneously advanceable along the guide member 86 to the joint 446 after implantation of the annuloplasty ring structure 222, and includes (i) an adjustment mechanism interface 462, which is sized to interface (e.g., engage) with the adjustment mechanism 40, and (ii) a joint interface 464, which is sized to interface (e.g., engage) with the joint 446; and includes a force applying device 466. For some applications, and as shown, the force applying device 466 is defined by a distal portion of the joint interface 464. The tool 460 is configured to (1) actuate the unlocking mechanism 450 by applying a force to the unlocking mechanism with the force applying device 466 when the joint 446 is coupled to the adjustment mechanism 442, causing the lock 444 to move to its unlocked state, and (2) actuate the adjustment mechanism 40 via the interface between the adjustment mechanism interface 462 and the adjustment mechanism. Generally, the tool 460 is also configured to decouple the head 446 from the adjustment device 442 .

[0542] For some applications, and as shown, the force applying device 466 is axially slidable relative to the joint 446 and is configured to actuate the unlocking mechanism 450 by applying an axial force (e.g., distal force) to the unlocking mechanism. For such applications, the joint interface 464 (or at least its force applying device 466) is generally axially slidable relative to the adjustment mechanism interface 462. Fig.17A The force applying device 466 is shown sliding axially distally relative to the interface 462, and Fig. 17B -C shows (in isometric and cross-sectional views, respectively) the force applicator slid axially proximally relative to the interface 462, e.g., such that the force applicator is disposed within a tubular portion 468 of the interface 462. Such sliding is generally driven via a control rod 470 that is coupled to the joint interface 464 and accessible from outside the subject, e.g., extending from the joint interface to the outside of the subject, such as to a handle (not shown) of the tool 460.

[0543] For some applications, and as shown, slidability of tool 460 along guide member 86 is provided by and can slide via tubular rod 470. For some applications, and as shown, movement of adjustment mechanism interface 462 is facilitated via outer tube 472 and tubular portion 468, the distal end of which can define interface 462.

[0544] As described above, contraction of the annuloplasty ring structure 222 can be performed while monitoring the heart (e.g., using Doppler echocardiography) to determine the desired amount of contraction (generally, the amount of contraction that results in the least regurgitation). It is contemplated that for some applications, contact between the adjustment tool and the adjustment mechanism may interfere with such monitoring—e.g., by applying a force that temporarily deforms the valve anatomy. As described below, the system 440 provides for reversible and repeatable coupling of the adjustment tool 460 to the adjustment device 442, and repeatable unlocking, adjustment, and relocking of the adjustment device (e.g., the adjustment mechanism 40 thereof), thereby facilitating such monitoring by allowing monitoring to be performed when the adjustment tool is not in contact with the adjustment device.

[0545] Fig.18A -K shows some techniques applied to system 440 according to the present invention. Fig.18A The annuloplasty ring structure 222 is shown implanted at the valve 230. The connector 446 is coupled to the adjustment device 442; the annuloplasty ring structure 222 is typically percutaneously advanced and implanted while the connector is coupled to the adjustment device.

[0546] Subsequently, tool 460 is advanced toward adjustment device 442 via guide member 86, as described with respect to tool 87 (with appropriate changes as appropriate to the actual situation) ( Fig.18B ). The joint interface 464 is slidable through the body 452 to an extent sufficient to allow the force applying device 466 to reach the attachment 451. For some applications, and as shown, the distal portion of the joint interface 464 (e.g., the force applying device 466) is angled so that in response to axial sliding of the joint interface on the proximal portion of the body 452, the joint interface automatically assumes a predetermined rotational orientation relative to the body; generally so that the force applying device is aligned with the attachment 451. For some applications, and as shown, the proximal portion of the joint 446 is angled so that in response to axial sliding of the joint interface 464 on the proximal portion of the body 452, the joint interface automatically assumes a predetermined rotational orientation. For example, and as shown, the body 452 may define one or more shoulders 454 that are angled in this manner.

[0547] This automatic rotation alignment is determined by Fig. 18C -E Example. Fig. 18C In the embodiment, the tool 460 reaches the joint 446 with the joint interface 464 and the force applying device 466 misaligned. For example, the joint interface 464 is rotated so that the force applying device 466 is not aligned with the attachment 451. Fig.18D It is shown that in response to further axial sliding of the joint interface 464 on the body 452, the joint interface automatically rotates to a predetermined orientation in which the force applying device 466 is aligned with the attachment 451. As described above, this can be facilitated by an angled portion of the joint interface 464 and / or an angled portion of the body 452. Fig.18EFurther axial advancement of tool 460 is shown causing adjustment mechanism interface 462 to engage adjustment mechanism 40. As shown, at this point, lock 444 is locked—eg, with detent 445 inhibiting adjustment mechanism 40 from actuation (eg, rotation).

[0548] Subsequently, the force applying device 466 actuates the unlocking mechanism 450 (eg, by applying an axial force thereto, such as via the attachment 451), and the unlocking mechanism 450 correspondingly unlocks the lock 444 ( Fig.18F ). For example, and as shown, the pin of the unlocking mechanism 450 is axially slidable within its channel and presses on the depressible portion 443 of the lock 444, thereby disengaging the pawl 445 from the adjustment mechanism 40. Note that when (i) the joint interface 464 is arranged on the body 452, and (ii) the force applying device 466 contacts the unlocking mechanism 450 (e.g., its attachment 451), the non-circular shape of the body inhibits the joint interface from further rotating in response to further axial sliding of the joint interface on the body. For example, the angle of the force applying device 466 that causes the joint interface 464 to rotate when it is axially pushed on the body 452 can also provide a rotational force to the joint interface when the joint interface is axially pushed against the attachment 451. This rotational force is resisted by the non-circular shape of the body 452 and the corresponding (e.g., matching) shape of the joint interface 464.

[0549] When the lock 444 is unlocked, the adjustment mechanism interface 462 actuates the adjustment mechanism 40 to change the size of the implant (eg, to shrink the implant)—for example, by adjusting the tension of the shrink member 226 ( Figure 18G ).

[0550] After such adjustment, tool 460 is withdrawn along guide member 86 away from annuloplasty ring structure 222, e.g., partially or completely withdrawn into outer catheter 12, while guide member 86 is still coupled to the implant (e.g., coupled to adjustment device 442 via connector 446) ( Fig.18H ). At this point, the lock 444 is in a locked state, having been re-locked before the adjustment mechanism interface 462 was decoupled (e.g., clutched) from the adjustment mechanism 40. For some applications, the lock 444 is actively locked by a force applied thereto by the unlocking mechanism 450. However, the lock 444 is generally biased to be in its locked state, and thus automatically locks after the compressive force is removed—e.g., by retracting the force applying device 466, or by retracting the entire tool 460.

[0551] In this state, the anatomical structure and / or functional status of the valve 230 is observed, for example, using Doppler echocardiography (eg, Fig.18H) or another imaging technique to determine whether the desired amount of contraction has been achieved. For example, regurgitation from valve 230 can be observed to determine whether the regurgitation has been sufficiently reduced (e.g., eliminated). Tool 460 can then be returned to adjustment device 442 and readjusted (18I).

[0552] The system 440 facilitates repeated cycles of engagement, adjustment, and disengagement of the adjustment device 442. It is contemplated that for some applications, the annuloplasty ring structure 222 may recover at least halfway toward its previous shape or size in the absence of locking of the lock 444 before (or after) each disengagement. For example, in the absence of such locking, the tendency of the native annulus to recover toward its previous circumference upon each disengagement of the adjustment mechanism interface 462 from the adjustment mechanism may additionally cause the retraction member 226 to unwind from the adjustment mechanism 40. Additionally, the independence between (i) disengagement of the guide member 86 from the adjustment device 442 and (ii) unlocking and locking of the lock 444 further facilitates repeated retraction and reengagement of the tool 460. Together, these features facilitate (i) observation of the condition of the valve 230 after adjustment in the absence of forces applied by the tool 460 to the valve and / or to the annuloplasty ring structure 222, and (ii) subsequent re-adjustment of the implant at least in part in response to such observation.

[0553] After the desired amount of adjustment has been achieved, tool 460 is used to decouple joint 446 from adjustment device 442 (thereby decoupling guide member 86). Generally, this is accomplished by (i) rotating joint 446 using joint interface 464 (e.g., by applying torque to body 452), while (ii) applying a reference force to adjustment device 442 using adjustment mechanism interface 462 (e.g., holding drive interface 476 stationary), thereby decoupling (e.g., untwisting) fastener 448 from the adjustment device ( Fig.18J The tool 460 and guide member 86 are then withdrawn from the subject ( Figure 18K ).

[0554] For some applications, the coupling head 446 (and thus the guide member 86) is not decoupled from the adjustment device 442 at the end of the procedure, and the proximal end of the guide member 86 remains accessible from outside the body - for example, using a port. For such applications, the adjustment mechanism 40 can be accessed and readjusted in a subsequent procedure.

[0555] refer to Fig.19A-F, These are schematic diagrams of a dynamometer 500 and its application techniques according to some applications of the present invention. It is contemplated that for some applications, it is advantageous to test the anchoring strength of an individual anchor after it is anchored and before a subsequent anchor is anchored. For some applications, this is accomplished using a dynamometer, such as the dynamometer 2800 described in PCT Application Publication WO 2014 / 064694 (which is incorporated herein by reference in its entirety). For some applications, and as referenced Fig.19A -F, this is achieved using a dynamometer 500.

[0556] A method is described, the method comprising: (1) percutaneously advancing an annuloplasty ring structure 222 (e.g., as described above) toward an implantation site using an implant handle 126 coupled to the annuloplasty ring structure 222 (via a reference force tube 19); and (2) sliding the implant relative to a guide catheter 14 without causing the implant to apply force to tissue at the implantation site by applying a first force to the implant handle. Fig.19B ); (3) measuring the magnitude of the first force ( Fig.19B ); (4) then anchoring the implant to the tissue at the implantation site ( Fig.19E ); (5) subsequently, by applying a second force to the implant handle, the implant applies a third force to the tissue at the implant site via the implant anchor ( Fig.19F ); (6) measuring the magnitude of the second force; and (7) determining the magnitude of a third force in response at least in part to the difference between the magnitude of the first force and the magnitude of the second force.

[0557] A force gauge 500 is provided on the handle 126 and is coupled to the annuloplasty ring structure 222 via a reference force tube 19. The force gauge 500 indicates the intensity of a force (e.g., a tensile force) applied to the annuloplasty ring structure 222 via the force gauge. For some applications, and as shown, the force gauge 500 includes a clamp 502 that facilitates applying force to the annuloplasty ring structure 222 using the handle 126 in a similar manner as if the force gauge were not present.

[0558] Fig.19A The annuloplasty ring structure 222 is shown implanted at the valve 230, wherein (i) the distal end of the flexible sleeve 26 has been anchored to the valve annulus 240 using the first anchor 32, (ii) successive portions of the flexible sleeve 26 have been detached from the implant disengagement channel 18, and (iii) the implant disengagement channel 18 is in a position to anchor the second anchor, sandwiching the flexible sleeve 26 against the tissue. Fig.19A The status shown is generally consistent with Figure 3D The status shown is the same (appropriate changes will be made based on actual conditions).

[0559] Prior to anchoring the second anchor, the annuloplasty ring structure 222 is slid relative to the guide catheter 14 by applying force via the clamp 502 without causing the implant to apply force to tissue at the implant site. Fig.19B The clamp 502 is shown being pulled proximally, causing the reference force tube 19 (and thus the proximal portion of the flexible sleeve 26 coupled thereto) and the implant decoupling passage 18 (disposed through the reference force tube 19) to be pulled proximally together. (The reference force tube 19 and the implant decoupling passage 18 do not move relative to each other because the knob 94 remains stationary.) The pulling is generally stopped immediately after movement of the stem 126 is observed, and the portion of the flexible sleeve 26 disposed between the implant decoupling passage 18 and the first anchor is generally not tensioned, and therefore, does not cause the annuloplasty ring structure 222 to apply force to the tissue. The force required to move the stem 126 proximally is measured using the indicator 504 of the force gauge 500. The indicator 504 is generally a peak force indicator that continuously indicates the maximum force experienced—when the force is no longer present. Fig.19B Frame (i) shows that the indicator 504 indicates "0" on the scale 506 before the pulling clamp 502, and frame (ii) shows that the indicator 504 indicates "1" on the scale 506 after the pulling clamp.

[0560] Since no force is applied to the tissue (e.g., because the portion of the flexible sleeve 26 disposed between the implant decoupling passage 18 and the first anchor is not tensioned), the measured force is indicative of the friction between (i) the reference force tube 19 (and in some cases the proximal portion of the flexible sleeve 26) and (ii) the guide catheter 14. Such friction is typically present in transcatheter systems, and for some applications, such friction is intentionally provided, as described above, to reduce the likelihood of accidental sliding of the reference force tube 19 through the guide catheter 14. Typically, the force required to overcome static friction (i.e., the force required to initiate implant sliding) is greater than the force required to overcome dynamic friction (i.e., the force required to keep the implant sliding). Thus, even if traction is stopped immediately after movement of the handle 126 is observed, force measurements can be made. This is therefore advantageous in avoiding the application of force to the tissue via the annuloplasty ring structure 222 (which (i) might otherwise occur if a greater degree of movement is desired, and (ii) would interfere with the measurement of friction alone).

[0561] As described above, the force used to slide the implant without causing the implant to apply force to the tissue is then compared to the force used to apply force to the tissue via the previously implanted anchor ( Fig.19F). The result of this comparison indicates the magnitude of the net force applied to the anchor via the flexible sleeve 26 (i.e., the total force applied minus the force required to overcome friction). Successfully pulling on the anchor with a force greater than the predetermined threshold force without the anchor becoming unanchored indicates successful anchoring of the anchor. The dynamometer 500 facilitates accurate identification that the predetermined threshold force has been achieved, thereby allowing the operator to not pull harder than required for this identification. The dynamometer 500 thus reduces the likelihood of applying an unnecessarily strong pulling force to the anchor via the flexible sleeve 26.

[0562] Fig.19B -C shows an application of the present invention to facilitate comparison of pre-anchoring force and post-anchoring force. For this application, scale 506 is zero-adjustable (e.g., resettable). After measuring the pre-anchoring force ( Fig.19B ), zeroing the scale 506 to the value indicated by the peak indicator 504. This is done by Fig.19C The scale 506 in FIG. 1 is shown slidingly, but it is noted that the scope of the present invention includes other techniques for zeroing the scale. Fig.19F The indicated post-anchor forces shown are the net forces applied to the anchor via the flexible sleeve 26, ignoring the forces required to overcome friction.

[0563] For some applications, a force gauge may alternatively or additionally be provided on a proximal portion (not shown) of the anchor driver 36. In this case, the anchor may be pulled directly, rather than through the flexible sleeve 26. However, for applications where the implant disengagement passage 18 retains the flexible sleeve 26 sandwiched against the tissue until after the anchor driver 36 is disengaged from the anchor 32 (e.g., Figure 3C and Figure 4A In some applications (e.g., Figure 3C and Figure 4B (A) sequence example), this disadvantage may not apply.

[0564] Fig.19A -F shows that the measured force is a tensile force. However, for some applications, the measured force (or at least one measured force) is a thrust. It is contemplated that for some applications, the resistance (e.g., friction) between (i) the reference force tube 19 (and optionally portions of the flexible sleeve 26) and (ii) the guide catheter 14 is generally equal in either axial direction. For some such applications, the pre-anchor measured force is a thrust, which is used in the same manner (with appropriate variations depending on the actual situation) to determine the net force applied to the anchor. It is contemplated that for some applications, this advantageously facilitates movement of the implant disengagement channel 18 and the flexible sleeve 26 toward the anchoring point (e.g., by Figure 4A and 4B The anchor force measurement during the transition from step B to step C in FIG. Fig.19B The steps shown here shorten the overall procedure.

[0565] Alternatively or additionally, such a measurement of thrust resistance may be used to confirm successful positioning of the distal end of the implant disengagement channel 18 against tissue. For example, distal movement of the distal end of the implant disengagement channel 18 (and / or, if it is the handle 126) before the applied thrust reaches a certain threshold may indicate that the implant disengagement channel 18 is positioned against weaker tissue (e.g., leaflet tissue), while a higher resistance may indicate that the tube is positioned against stronger tissue (e.g., the annulus 240, or the fibrous trigone).

[0566] Reference Fig. 20 , which is a schematic diagram of a system 600 including an implant configured to be delivered into a subject's heart according to some applications of the present invention. The implant includes an annuloplasty ring structure 222 (i.e., an implant, e.g., an annuloplasty band) that includes a flexible sleeve 26 (as described above with reference to Figure 1 As described above, the annuloplasty ring structure 222 includes a contraction member 226 extending along the flexible sleeve 26 .

[0567] like Fig. 20As shown in the following figure, during the anchoring of the flexible sleeve 26 along the circumference of the annulus 240, as each of the anchors 32 is successively deployed, the flexible sleeve 26 successfully twists helically around its longitudinal axis at the entry site of each successive anchor 32. That is, as each of the anchors 32 is successively deployed, the tension and distortion of the flexible sleeve 26 increases as it is positioned around the circumference of the annulus 240. As the contraction member 226 passes through the flexible sleeve 26, the twisting and distortion of the flexible sleeve 26 causes the contraction member 226 to present a spiral path relative to the tissue of the annulus 240 as the sleeve twists. In response to the twisting of the sleeve, portions of the contraction member 226 are disposed further away from the tissue (i.e., the portions of the member 226 in that portion of the flexible sleeve 26 that are positioned earliest against the annulus), while other portions of the contraction member 226 are disposed closer to the tissue of the annulus 240 (i.e., the portions of the member 226 in that portion of the flexible sleeve 26 that are positioned later against the annulus after the sleeve assumes a curved shape corresponding to the curve of the annulus 240). Thus, twisting of some portions of the flexible sleeve 26 causes a portion of the contraction member 226 to be co-linear and in close proximity to the tissue of the annulus 240 for a given portion of the flexible sleeve 26, and in some cases in the path of the anchor 32 through that portion of the flexible sleeve 26. In such a case, that portion of the contraction member 226 may become entangled with the anchor 32 passing through that portion of the flexible sleeve 26, and ultimately compromise smooth tensioning of the contraction member 226 in response to actuation of the adjustment mechanism 40. For some applications, entanglement of retraction member 226 with anchor 32 increases friction between portions of retraction member 226 and portions of flexible sleeve 26 .

[0568] Reference Fig.21 , which is a schematic diagram of a system 610 according to some applications of the present invention, the system 610 including an implant configured to be delivered into a subject's heart. The implant includes an annuloplasty ring structure 611 (i.e., an implant, e.g., an annuloplasty band) that includes a flexible sleeve 26 defining a basic body portion 750 of the structure 611. Note that the annuloplasty structure 611 is similar to the annuloplasty ring structure 611 described throughout this application and specifically in reference above. Figure 1 The annuloplasty ring structure 222 is depicted except for the coupling of the retraction member 226 relative to the flexible sleeve 26, as described below.

[0569] The contraction member 226 of the structure 611 has a first end coupled to the adjustment mechanism 40 and a second end coupled to a portion of the main body 615 of the structure 611. The member 226 defines a first longitudinal portion 612 extending from the first end and through the contraction portion of the main body 615 of the structure 611. The first longitudinal portion 612 extends along a first longitudinal path. For some applications, when the structure 611 is in a linear shape and when the structure 611 is in a state where no twist or torsion is applied to the flexible sleeve 26, the first longitudinal path is parallel relative to the longitudinal axis of the main body 615. For some applications of the present invention, and as Fig.21 As shown, the main body portion 615 includes the flexible sleeve 26. The member 226 also defines a second longitudinal portion 616 that passes through the constricted portion of the main body portion 615 of the structure 611 and extends toward the second end of the member 226. When the structure 611 is in a state where no twist or torsion is applied to the flexible sleeve 26, the second longitudinal portion 616 extends along a second longitudinal path that is offset relative to the first longitudinal path. For some applications, when the structure 611 presents a linear shape, the second longitudinal path is parallel relative to the longitudinal axis of the main body portion 615. Additionally, the member 226 defines an offset portion 614 that offsets the first and second longitudinal portions 612 and 616 of the constricted member 226.

[0570] For some applications of the present invention, the offset portion 614 extends along a stepped path when the structure 611 is in a state where no twist or torsion is applied to the flexible sleeve 26. For some applications of the present invention, the offset portion 614 extends along a helical path. For some applications of the present invention, the contraction member 226 is coupled to the flexible sleeve 26 in a manner that at least a portion of the contraction member 226 is helically arranged about the longitudinal axis A of the flexible sleeve 26 of the annuloplasty ring structure 222. For some applications, the portion 614 defines at least between 1-5% (e.g., between 1-2%) of the contraction member 226 that is helically arranged about the longitudinal axis A.

[0571] For some applications, Fig.21 As shown, the main body 615 of the annuloplasty structure 611 is tubular and includes first and second longitudinal portions 612 and 616, which are offset by a distance Di1 of 0.3-0.7 radians, for example, 0.5 radians. For some applications, the first and second longitudinal portions 612 and 616 are offset by a distance of 0.8-1.2 mm, for example, 1 mm.

[0572] For some applications of the present invention, first and second longitudinal portions 612 and 616 and offset portion 614 penetrate into and out of the braided material of flexible sleeve 26 .

[0573] For some applications, when structure 611 assumes a linear shape, flexible sleeve 26 includes a flexible tubular wall defining a central longitudinal axis of flexible sleeve 26. Flexible sleeve 26 has a lumen having a distal end (i.e., at end wall 251 of flexible sleeve 26), a proximal end, and a length therebetween. Contraction members 226 are coupled to flexible sleeve 26 such that tensioning contraction members 226 reduces the lumen length. Contraction members 226 are interwoven through or through the sidewalls such that, in the absence of twisting of the sleeve about the longitudinal axis, such as Fig.21 As shown in the upper figure in FIG. 2 , at least a portion of the contraction member 226 is arranged helically around the longitudinal axis.

[0574] After the flexible sleeve 26 is bent corresponding to the shape of the valve ring 240, the flexible sleeve 26 naturally twists during the bending process, as described above with reference to Fig. 20 Even during and after torsion of the flexible sleeve 26, the offset portion 614 enables the second longitudinal portion 616 of the member 226 to (1) face the atrium and / or (2) face the center C of the structure 611 after the structure 611 is bent to correspond to the shape of the annulus 240. In this way, the portion 616 is positioned away from the portion of the flexible sleeve 26 that abuts the annulus 240 tissue and away from any path of the anchor 32 through that portion of the flexible sleeve 26 that abuts the annulus 240 tissue.

[0575] Additionally, since the offset portion 614 enables the second longitudinal portion 616 of the member 226 to face the center C of the structure 611 after the structure 611 is bent in accordance with the shape of the annulus 240, the contraction member 226 is more evenly extended along the inner wall of the flexible sleeve 26 facing the center C after the structure 611 is bent in accordance with the shape of the annulus. That is, the portion 616 is not helically arranged relative to the tissue, nor is any segment of the portion 616 arranged in close proximity to the tissue of the annulus 240. With this more even extension of the member 226 along the inner wall of the flexible sleeve 26 facing the center C, the contraction member 226 is able to cause the structure 611 to radially contract more evenly after the structure 611 is bent in accordance with the shape of the annulus because the force of the member 226 from the inner wall of the flexible sleeve 26 facing the center C is more evenly distributed along the bending path of the flexible sleeve 26 after the structure 611 is bent in accordance with the shape of the annulus.

[0576] Additionally, after the structure 611 is bent in accordance with the shape of the annulus, the offset portion 614 enables the structure to assume a configuration in which the entire contraction member 226 is arranged along the inner periphery of the structure 611 (i.e., facing the center C) and not along any portion of the outer periphery of the structure 611. As such, this configuration prevents the member 226 from becoming entangled with any anchors anchored to the outer periphery of the structure 611 through the flexible sleeve 26, as described above, for example, with reference to Figure 3A -G and 4A-B.

[0577] Note that the helical orientation coupling of member 226 to flexible sleeve 26 of structure 611, such that member 226 defines portions 612, 614, and 616, can be applied to any of the annuloplasty structures 222 described herein. Additionally, note that any of the systems for annuloplasty structures 222 described herein can be applied in combination with annuloplasty structure 611.

[0578] Reference Fig.22A -C, these are schematic diagrams of a system 620 according to some applications of the present invention, the system 620 comprising an implant configured to be delivered into a subject's heart. The implant comprises an annuloplasty ring structure 222 (i.e., an implant, e.g., an annuloplasty band), the annuloplasty ring structure 222 comprising a flexible sleeve 26 defining a basic body portion 750 of the annuloplasty ring structure 222 (as described above with reference to Figure 1 described above).

[0579] Fig.22A With the above Fig. 20 Similar, except that the torsion of the flexible sleeve 26 of the annuloplasty ring structure 222 is shown to be greater than Fig. 20 The flexible sleeve 26 is twisted so that a portion of the contraction member 226 is arranged on the lower side of the annuloplasty ring structure 222 after the annuloplasty ring structure 222 is bent corresponding to the curved shape of the annulus 240. In this way, during the anchoring of the anchor 32 by the twisted portion of the flexible sleeve 26, there is a possibility that the anchor 32 may be entangled with the portion of the contraction member 226 arranged adjacent to the tissue of the annulus 240. Additionally, in the twisted state of the flexible sleeve 26, after the annuloplasty ring structure 222 is bent corresponding to the annulus shape, the contraction member 226 is not evenly and uniformly arranged along the inner wall of the flexible sleeve 26 facing the center C. As described below with reference to Fig. 22B -C description, to prevent Fig.22A Any portion of the contraction member 226 shown is disposed adjacent to the annular tissue to actively twist the flexible sleeve 26 about the central longitudinal axis A of the implant disengagement passage 18 disposed within the flexible sleeve 26 and / or rotate the annuloplasty ring structure 222 about the axis A when the flexible sleeve 26 assumes a linear shape prior to delivery of the annuloplasty ring structure 222.

[0580] Typically, the second end 429 of the retraction member 226 (i.e., the end not coupled to the adjustment mechanism 40) is fixedly coupled to the flexible sleeve 26 (e.g., using a crimp bead, as shown). Fig.22A As shown in the upper figure, in the resting state of the annuloplasty ring structure 222, the distance between the second end 429 of the contraction member 226 and the position 624 along the flexible sleeve 26 where the contraction member 226 is away from the flexible sleeve 26 and toward the adjustment mechanism 40 is between 0 and 0.25 radians. Fig.22AAs shown in the upper figure in FIG. 1 , the twist angle between the second end 429 of the retraction member 226 and the position 624 is between 0 and 10 degrees.

[0581] Fig. 22B The annuloplasty ring structure 222 is shown actively twisted about the longitudinal axis A of the implant disengagement passage 18. In the twisted state, as shown Fig. 22B As shown in the upper figure of FIG. 1 , the second end 429 of the contraction member 226 is between 2.5 and 3.5 arcs away from the contraction member 226 and toward the position 624 along the flexible sleeve 26 where the adjustment mechanism 40 is located. Fig. 22B As shown in the upper figure in FIG. 1 , the twist angle between the second end 429 of the contraction member 226 and the position 624 is between 170 and 190 degrees, for example, 180 degrees.

[0582] As described throughout this application and referenced above Figure 1-2 In the specific description, the annuloplasty ring structure 222 is advanced in the guide catheter 14. The implant disengagement channel 18 is arranged in the lumen of the annuloplasty ring structure 222. Fig. 22B As shown in Figure 2-C, the annuloplasty ring structure 222 includes a flexible sleeve 26 that defines a cavity having a proximal end, a distal end, and a central longitudinal axis therebetween. The annuloplasty ring structure 222 is longitudinally slidable through the guide catheter 14 when the flexible sleeve 26 is twisted about the axis of the flexible sleeve 26 and about the axis A of the implant disassembly passage 18. The implant disassembly passage 18 is longitudinally slidable through the guide catheter 14 when the flexible sleeve 26 of the annuloplasty ring structure 222 covers the distal portion of the implant disassembly passage 18 while twisting about the flexible sleeve axis. The annuloplasty ring structure 222 is longitudinally slidable through the guide catheter 14 having the implant disassembly passage 18 when the flexible sleeve 26 covers the distal portion of the passage 18 while the flexible sleeve 26 is twisted about the axis of the flexible sleeve 26.

[0583] For some applications of the present invention, the flexible sleeve 26 is twisted so that the twist angle between the proximal and distal ends is 170-190 degrees, for example, 180 degrees. That is, the adjustment mechanism 40 is twisted from the second end 429 of the retracting member 226 to a twist angle between 140-180 degrees, for example, between 155 and 175 degrees.

[0584] During the process of the flexible sleeve 26 being arranged around the valve ring 240, successive portions of the flexible sleeve 26 are progressively released from the implant disassembly passage 18, as described above. As successive portions of the flexible sleeve 26 are released from the implant disassembly passage 18, the torsion angle of the flexible sleeve 26 is naturally and passively reduced in a manner that the contraction member 226 is arranged facing the center C of the valve 230.

[0585] Alternatively, after the annuloplasty ring structure 222 is bent in accordance with the shape of the annulus, as shown in FIG. Fig. 22B As shown in the lower figure of FIG. 2 , the sleeve 26 is actively twisted before delivery, and then the twisting angle of the flexible sleeve 26 is reduced during release, so that the annuloplasty ring structure 222 can present the following configuration: the entire contraction member 226 is arranged along the inner periphery of the annuloplasty ring structure 222 (i.e., facing the center C) and not along any part of the outer periphery of the annuloplasty ring structure 222. As such, this configuration prevents the annuloplasty ring structure 222 from being deformed as described above (e.g., referring to FIG. 2 ). Figure 3A -G and 4A-B) entanglement of the member 226 with any anchors anchored to the periphery of the annuloplasty ring structure 222 by the flexible sleeve 26.

[0586] Fig. 22C The annuloplasty ring structure 222 is shown rotated about the central longitudinal axis A of the implant disengagement passage 18 when the flexible sleeve 26 is twisted, as described above with reference to FIG. Fig. 22B When the annuloplasty ring structure 222 is rotated about the central longitudinal axis of the implant disengagement passage 18 in a first rotational direction indicated by arrow 622 and the distal end of the flexible sleeve 26 is distal to the distal end of the guide catheter 14, the adjustment mechanism 40 is adjacent to a first position of the flexible sleeve 26, which first position corresponds to a first point along the distal perimeter of the implant disengagement passage 18, as shown in FIG. Fig. 22C As shown in the figure above.

[0587] Additionally, after the annuloplasty ring structure 222 is bent in accordance with the annular shape, the flexible sleeve 26 is rotated before delivery, and then the torsion angle of the flexible sleeve 26 during release is reduced, so that the annuloplasty ring structure 222 can assume a configuration in which the entire contraction member 226 is arranged along the inner circumference of the annuloplasty ring structure 222 (i.e., facing the center C) and not along any portion of the outer circumference of the annuloplasty ring structure 222. As such, this configuration prevents the annuloplasty ring structure 222 from being deformed as described above (e.g., with reference to FIG. 2 ). Figure 3A -G and 4A-B) member 226 becomes entangled with any anchors anchored to the periphery of the annuloplasty ring structure 222 by the flexible sleeve 26.

[0588] Reference Fig. 22B -C. For some applications of the present invention, only the flexible sleeve 26 is Fig. 22B As shown, the annuloplasty ring structure 222 is twisted about the axis A, while the annuloplasty ring structure 222 is not as Fig. 22C 26 is shown rotating about axis A. For some applications of the present invention, the flexible sleeve 26 is Fig. 22B As shown, the annuloplasty ring structure 222 is twisted about the axis A, and .... Fig. 22C Rotation about axis A is shown.

[0589] Reference Fig.21 and 22A -C. Note that the above reference can be used Fig.21The structure described in 611, instead Fig.22A -C shows the annuloplasty ring structure 222.

[0590] Reference Fig.23A -B, a schematic diagram of a system 630 according to some applications of the present invention, the system 630 comprising an implant configured to be delivered into a subject's heart. The implant comprises an annuloplasty ring structure 631 (i.e., an implant, e.g., an annuloplasty band), the annuloplasty ring structure 631 comprising a flexible sleeve 26. Note that the annuloplasty ring structure 631 is similar to the annuloplasty ring structure 631 described above with reference to Fig.21 The structure 611 described is similar, except that the structure 631 includes a retraction member protection element 633. The flexible sleeve 26 defines a general body portion 750 of the annuloplasty structure 631.

[0591] The contraction member 226 defines (1) a first portion 6331 extending along the contraction portion of the flexible sleeve 26 and extending away from the flexible sleeve 26 at the connection point 635, and (2) a second portion 6332 extending away from the flexible sleeve 26 and extending to the adjustment mechanism 40. The contraction member protection element 633 protects the second portion 6332 - because the portion 6332 is disposed outside the wall 253 of the flexible sleeve 26 and away from the flexible sleeve 26. Additionally, the element 633 provides a path along which the portion 6332 slides during tensioning and pulling of the contraction member 226. This path provided by the element 633 prevents the portion 6332 from getting tangled during tensioning and pulling of the contraction member 226.

[0592] Additionally, the retraction member protection element 633 protects the second portion 6332 from any tools disposed proximal to the implant. Specifically, the retraction member protection element 633 protects the second portion 6332 by at least a majority of the covering portion 6332.

[0593] like Fig.23A -B, the contraction member protection element 633 includes a contraction member protection element sleeve 634, which defines a cavity passing therethrough, and the second portion 6332 of the contraction member 226 is arranged in the second cavity and extends to the adjustment mechanism 40. Therefore, the flexible sleeve 26 of the structure 631 defines a first sleeve 637, and the contraction member protection element sleeve 634 defines a second sleeve 639, which defines a second cavity passing therethrough, and the second portion 6332 of the contraction member 226 is arranged in the second cavity of the second sleeve 639 and extends to the adjustment mechanism 40. The second sleeve 639 acts as a connector, coupling the adjustment mechanism 40 to the first sleeve 637 of the structure 631.

[0594] For some applications of the present invention, the second sleeve 639 serves as the Figure 1Connector 27 is described.

[0595] For some applications of the present invention, the retracting member protection element sleeve 634 is similar to the above reference Figure 1 The flexible sleeve 26 described comprises the same material. For some applications of the present invention, the retracting member protection element sleeve 634 covers the adjustment mechanism 40. For some applications of the present invention, the flexible sleeve 26, the retracting member protection element sleeve 634, and the fabric covering the adjustment mechanism 40 are made of the same material. For some applications of the present invention, the flexible sleeve 26, the retracting member protection element sleeve 634, and the fabric covering the adjustment mechanism 40 are made of a single piece (i.e., except for the proximal opening of the flexible sleeve 26, the structure 631 is completely covered by the fabric).

[0596] The retraction member protection element 633 has (1) a first end coupled to the basic body portion 750 (i.e., the flexible sleeve 26) of the structure 631, and (2) a second end coupled to the adjustment mechanism 40. The retraction member 226 extends from the adjustment mechanism 40 to the basic body portion 750 (i.e., the flexible sleeve 26) of the structure 631 via the retraction member protection element. The retraction member 226 enters the flexible sleeve 26 at the connection point 635 and then continues to extend along the retraction portion of the flexible sleeve 26. That is, the structure 631 defines a retraction portion of the structure 631 (i.e., the sleeve portion through which the first portion 6331 of the retraction member 226 extends) and a non-retraction portion 6333 (i.e., the portion of the flexible sleeve 26 through which no retraction member 226 extends). Generally, the non-retraction portion of the flexible sleeve 26 includes the portion of the flexible sleeve 26 distal to the connection point 635 and extending to the distal wall 251. Typically, the connection point 635 is at least 10 mm, e.g., at least 15 mm, from either end of the structure 631, e.g., the connection point 635 is at least 10 mm, e.g., at least 15 mm, from the end wall 251. That is, typically, the first end of the retraction member protection element 633 is connected to the annuloplasty structure at a connection point 635, which is at least 10 mm, e.g., at least 15 mm, from either end of the annuloplasty structure, e.g., from the end wall 251, as shown. For some applications of the present invention, the connection point 635 is 10-15 mm from the end wall 251.

[0597] Reference Figure 3A -B and 23A-B. Figure 3A As shown, the adjustment mechanism 40 is advanced distally toward the mitral valve annulus to the distal end of the flexible sleeve 26. In this manner, the adjustment mechanism 40 is disposed on the longitudinal axis of the flexible sleeve 26 (e.g., in-line with the sleeve), thereby advantageously maintaining a small cross-sectional diameter of the implant for transluminal delivery. Figure 3B In the embodiment, after being exposed from the guide catheter 14 to at least the adjustment mechanism 40 (and generally at least the end wall 251 of the flexible sleeve 26), the adjustment mechanism is moved away from the end wall 251. Fig.23A -B, the retracting member protection element 633 facilitates such movement of the adjustment mechanism 40 by flexibly and / or articulating the mechanism 40 to the flexible sleeve 26. For some applications, the element 633 is tensioned or relaxed to move the mechanism 40 relative to the flexible sleeve 26, thereby repositioning the mechanism 40. For some applications, the guide member 86 is tensioned or relaxed to reposition the mechanism 40.

[0598] The element 633 is connected to the flexible sleeve 26 at the connection point 635 so as to enable the portion 6333 of the flexible sleeve 26 to be free of the contraction member 226 for a length L45 of the portion 6333 between 10-15 mm. That is, during delivery of the annuloplasty structure, the mechanism 40 is arranged most distally, following the portion 6333 without any contraction member 226 passing therethrough. During delivery, the element 633 is arranged side by side with the portion 6333. Therefore, L4 is slightly greater than L45. After the annuloplasty structure is contracted, as shown in FIG. Fig. 23B As shown, the outer surfaces of the adjustment mechanism 40 and the flexible sleeve 26 are adjacent at the connection point 635.

[0599] The contraction member protection element 633 has a longitudinal length L4 of 10-15 mm before tensioning the contraction member 226, as measured along the central longitudinal axis of the contraction member protection element 633. As described above, before adjusting the structure 631 by the adjustment mechanism 40, the structure 631 is advanced through the outer catheter 12. When the structure 631 is advanced through the outer catheter 12, in the delivery state of the structure 631, the adjustment mechanism 40 is arranged on the distal side (i.e., the front side) of the flexible sleeve 26. This configuration is shown in FIG. Figure 3A middle, Figure 3A The distal portion of the flexible sleeve 26 and the adjustment mechanism 40 disposed distal to the distal portion of the flexible sleeve 26 and exposed from the guide catheter 14 just after deployment from the outer catheter 12 are shown, although this configuration is maintained throughout advancement of the flexible sleeve 26 and the mechanism 40 through the outer catheter 12 in the delivery state of the annuloplasty structure. In this delivery state, the retraction member protection element 633 extends from the connection point 635, alongside a portion of the wall 253 of the flexible sleeve 26, to the adjustment mechanism 40 disposed distal to the flexible sleeve 26. In this manner, the adjustment mechanism 40 is disposed on the central longitudinal axis of the flexible sleeve 26 (e.g., in-line with the sleeve), thereby advantageously maintaining a small cross-sectional diameter of the implant for transluminal delivery.

[0600] like Figure 3AAs shown, the most distal portion of the contraction member 226 is disposed distal to the distal end of the guide catheter 14 (i.e., tube) at a first distance from the distal end of the guide catheter 14, and a portion (i.e., distal portion) of the adjustment mechanism 40 is disposed distal to the contraction member 226 at a second distance from the distal end of the guide catheter 14, the second distance being greater than the first distance. During the initial deployment of the outer catheter 12 from within the outer catheter 12 (i.e., tube), the most distal portion of the contraction member 226 is disposed distal to the distal end of the guide outer catheter 12 (i.e., tube) at a first distance from the distal end of the outer catheter 12, and a portion (i.e., distal portion) of the adjustment mechanism 40 is disposed distal to the contraction member 226 at a second distance from the distal end of the outer catheter 12, the second distance being greater than the first distance. That is, during the initial deployment of the guide catheter 14 from within the outer catheter 12, a portion (e.g., distal portion) of the adjustment mechanism 40 is disposed distal to the distal end of the outer catheter 12, while the contraction member 226 is disposed entirely within the outer catheter 12.

[0601] Reference Figure 3B and 23A After the distal portion of the flexible sleeve 26 is deployed in the atrium of the heart, the adjustment mechanism 40 can be moved away from the main body portion 750 and away from the flexible sleeve 26 (i.e., the main body portion 750 of the structure 631) by 10-15 mm, for example, 10 mm, which corresponds to the longitudinal length L4, as shown in FIG. Fig.23A Typically, the adjustment mechanism 40 is spaced from the sleeve via the second portion 6332 of the retraction member 226 and / or, as shown, the adjustment mechanism 40 is spaced from the sleeve via the retraction member protection element 633 .

[0602] like Fig. 23B As shown, after the distal deployment of the flexible sleeve 26, the structure 631 presents a deployed state, wherein by actuating the adjustment mechanism 40 and adjusting the tension of the contraction member 226, the mechanism 40 moves closer to the connection point 635, and the distance between the adjustment mechanism 40 and the main body 750 of the structure 631 (i.e., the flexible sleeve 26) is reduced, as shown in FIG. Fig. 23B shown.

[0603] When the adjustment mechanism 40 is actuated, tension is applied to the contraction member 226 as successive portions of the member 226 are wound around the reel of the mechanism 40. In response to the tensioning of the member 226, successive portions of the first sleeve 637 are contracted. After the first sleeve 637 is contracted, the second sleeve 639 (i.e., the contraction member protection element 633) contracts and changes shape due to the tension applied to the second portion 6332 of the contraction member 226. The contraction member protection element 633 protects the second portion 6332 of the contraction member 226 during the tensioning of the second portion 6332 of the contraction member 226.

[0604] In the process of reducing the distance between the adjustment mechanisms 40, the length of the contraction member protection element 633 is reduced, and the shape of the contraction member protection element 633 is changed. As shown in FIG. 23, the contraction member protection element 633 is closer to the wall 253 of the flexible sleeve 26 when compressed and / or folded, and a portion of the element 633 is pressed against the wall 253 of the flexible sleeve 26 of the structure 631. That is, at least a portion of the element 633 is pressed against the wall 253 of the flexible sleeve 26, and the element 633 has a compressed longitudinal length L44 of 0.5-1.5 mm, for example, 1 mm, measured along the longitudinal axis of the element 633. Fig. 23B As shown, before the adjustment mechanism 40 is actuated, the distance between the adjustment mechanism 40 and the flexible sleeve 26 is less than the distance between the adjustment mechanism 40 and the flexible sleeve 26 - corresponding to Fig.23A Length L4 shown.

[0605] like Fig. 23B As shown, after the structure 631 is in the deployed state, a plurality of tissue anchors 32 are used to anchor the structure 631 to the annulus 240. The plurality of tissue anchors 32 include (i) at least three tissue anchors 32 disposed at the distal portion (i.e., the non-contracted portion 6333) of the structure 631, and (ii) at least one tissue anchor 32 (e.g., a plurality, as shown) disposed at the contracted portion (i.e., the sleeve portion through which the first portion 6331 of the contraction member 226 extends) of the structure 631.

[0606] For some applications of the present invention, adjustment mechanism 40 is surrounded by a sheath 636 that is a continuation of second sleeve 639 .

[0607] Reference again Fig.23A -B. For some applications, retraction member protection element 633 includes a radiopaque material that acts as an adjustment indicator 632, providing an indication of the adjustment of retraction member 226 and the valvuloplasty structure. For some applications of the present invention, adjustment indicator 632 acts as a tension indicator, providing an indication of the tension of retraction member 226 and the valvuloplasty structure. Because element 633 changes shape based on the increase or decrease in the degree of tension of retraction member 226 (i.e., through portion 6332 of sleeve 639), the radiopaque material in element 633 enables element 633 to act as indicator 632. Fig. 23B As shown, a portion of the indicator 632 is pressed against the flexible sleeve 26 of the structure 631 .

[0608] For some applications of the present invention, the adjustment indicator 632 is generally coupled to the body portion 750 of the implant. For example, the implant includes an annuloplasty ring structure having a body portion 750 (e.g., the flexible sleeve 26), and the indicator 632 is directly coupled to the body portion 750 of the annuloplasty ring structure. As shown, the indicator 632 is directly coupled to the outer surface of the body portion 750 of the annuloplasty ring structure.

[0609] Note that the contraction member protection element 633 can be used in combination with any annuloplasty structure described herein (e.g., the annuloplasty ring structure 222, 611, or any other annuloplasty structure described below). Note that for some applications of the present invention, the annuloplasty structures described herein can be configured with or without the contraction member protection element 633.

[0610] Reference Fig.24A -B, these are schematic diagrams of a system 640 according to some applications of the present invention, the system 640 comprising an implant configured to be delivered into a subject's heart. The implant comprises an annuloplasty ring structure 641 (i.e., an implant, e.g., an annuloplasty band), the annuloplasty ring structure 641 comprising a flexible sleeve 26. Note that the annuloplasty ring structure 641 is similar to the annuloplasty ring structure 641 described above with reference to Fig.23A -B is similar to the structure 631 described above, except that the structure 641 includes a spring 642. The flexible sleeve 26 defines a basic body portion 750 of the annuloplasty structure 641.

[0611] The spring 642 is shaped so as to define a cavity surrounding the second portion 6332 of the retraction member 226. For some applications, the second portion 6332 extends side by side with the spring 642. The spring 642 is disposed within the retraction member protection element sleeve 634. For some applications of the present invention, the spring 642 comprises a telescopic spring, such as a truncated cone scroll spring, as shown. Note that any suitable spring can be positioned within the retraction member protection element sleeve 634. For example, a helical spring can be positioned within the retraction member protection element sleeve 634.

[0612] For some applications of the invention, spring 642 comprises a radiopaque material such that retraction member protection element 633 acts as adjustment indicator 632. For some applications of the invention, adjustment indicator 632 is generally coupled to a body portion of an implant. For example, the implant comprises an annuloplasty ring structure having a body portion (e.g., flexible sleeve 26), and indicator 632 is coupled directly to the body portion of the annuloplasty ring structure. As shown, indicator 632 is coupled directly to an outer surface of the body portion of the annuloplasty ring structure.

[0613] During the process of reducing the distance between the adjustment mechanism 40 and the flexible sleeve 26, as described above with reference to Fig.23A-B, the length of the contraction member protection element 633 is reduced, and the shape of the contraction member protection element 633 is changed. That is, in the process of reducing the distance between the adjustment mechanism 40 and the flexible sleeve 26, the spring 642 is compressed, as shown in FIG. Fig. 24B During the compression of spring 642, the shape of spring 642 changes, and thus, the radiopaque material of spring 642 provides an indication of the contraction of structure 641. That is, in response to the increase in the tension level of contraction member 226, by compressing spring 642, the shape of the radiopaque element of spring 642 changes. Fig. 24B As shown, a portion of the indicator 632 is pressed against the flexible sleeve 26 of the structure 641 .

[0614] Note that the contraction member protection element 633 and / or spring 642 can be used in combination with any annuloplasty structure described herein (e.g., annuloplasty ring structure 222, 611, 631, or any other annuloplasty structure described below). Note that for some applications of the present invention, the annuloplasty structures described herein can be configured with or without the contraction member protection element 633.

[0615] Reference Fig.25A -B, these are schematic diagrams of a system 640 according to some applications of the present invention, the system 640 comprising an implant configured to be delivered into a subject's heart. The implant comprises an annuloplasty ring structure 651 (i.e., an implant, e.g., an annuloplasty band), the annuloplasty ring structure 651 comprising a flexible sleeve 26. Note that the annuloplasty ring structure 651 is similar to the annuloplasty ring structure 651 described above with reference to Fig.23A -B is similar to the structure 631 described above, except that the structure 651 includes a band 654. The flexible sleeve 26 defines a basic body portion 750 of the annuloplasty structure 641.

[0616] The strap 654 defines the retraction member protection element 633 because the second portion 6332 of the retraction member 226 is interwoven, for example, through the strap 654 , and thus the strap 654 protects the portion 6332 of the retraction member 226 and prevents the portion 6332 from interfering with actuation of the adjustment mechanism 40 . Fig.25A The structure 651 is shown before the contraction member 226 is fully tensioned. In this state, the second portion 6332 is not tensioned, and the band 654 is in a relaxed state and is not pressed against the flexible sleeve 26 (i.e., it is in an unstressed state). In the relaxed, unstressed state, the band 654 defines a longitudinal length L4 of 10-15 mm, a width W3 of 3-5 mm, and a thickness of 0.1-0.3 mm measured along the longitudinal axis of the band. Typically, the width W3 of the band 654 is 10 times greater than the width of the contraction member 226.

[0617] In the relaxed, unstressed state of the band 654, the distance between the adjustment mechanism 40 and the flexible sleeve 26 (ie, the main body of the structure 631) is 10-15 mm, corresponding to the longitudinal length L4. Fig.25A Typically, the adjustment mechanism 40 is spaced from the flexible sleeve 26 via the second portion 6332 of the retraction member 226 and / or, as shown, the adjustment mechanism 40 is spaced from the flexible sleeve 26 via the band 654 of the retraction member protection element 633 .

[0618] For some applications of the present invention, retraction member protection element 633 includes a strip that acts as strap 654 .

[0619] When the contraction member 226 is sufficiently tightened by the adjustment mechanism 40 (i.e., when the tension level of the member 226 increases), the band 654 changes shape (e.g., compresses and / or folds, such as Fig.25B 654), thereby bringing the adjustment mechanism 40 closer to the wall 253 of the flexible sleeve 26. During the pulling of the retracting member 226, the portion 6332 slides along the length of the strap 654, which provides protection and a path for the sliding of the portion 6332 of the retracting member 226 during the sliding of the portion 6332 along the strap 654. Additionally, the strap 654 prevents the portion 6332 from becoming tangled during the pulling of the retracting member 226.

[0620] During the pulling of the contraction member 226 and the sliding of the portion 6332 along the belt 654, at least a portion of the belt 654 is pressed against the wall 253 of the flexible sleeve 26, and the belt 654 has a compressed longitudinal length L44 of 0.5-1.5 mm, for example 1 mm, measured along the longitudinal axis of the belt 654.

[0621] For some applications of the present invention, band 654 is used with the Figure 1 Flexible sleeve 26 is described as comprising the same material. For some applications, band 654 of retraction member protection element 633 comprises a radiopaque material that acts as adjustment indicator 632, providing an indication of adjustment of structure 651. Since element 633 changes shape in response to an increase or decrease in the degree of tension in retraction member 226 (i.e., along portion 6332 passing along band 654), the radiopaque material in element 633 enables element 633 to act as indicator 632. Fig.25B As shown, a portion of the indicator 632 is pressed against the flexible sleeve 26 of the structure 651 .

[0622] For some applications of the present invention, the adjustment indicator 632 is generally coupled to the main body portion of the implant. For example, the implant includes an annuloplasty ring structure having a main body portion (e.g., the flexible sleeve 26), and the indicator 632 is directly coupled to the main body portion of the annuloplasty ring structure. As shown, the indicator 632 is directly coupled to the outer surface of the main body portion of the annuloplasty ring structure.

[0623] Note that the band 654 may be used in combination with any of the annuloplasty structures described herein (eg, the annuloplasty ring structures 222, 611, 631, 641, or any other annuloplasty structure described below).

[0624] Reference Figures 23A-25B , these display adjustment mechanism 40 is coupled to the retracting member 226 at a first end of the retracting member 226, and the indicator 632 is coupled to the retracting member 226 at a second portion 6332 of the retracting member 226. Figures 23A-25B In the embodiment of the present invention, the second portion 6332 is adjacent to the adjustment mechanism 40 such that the indicator 632 and the radiopaque material are arranged adjacent to the adjustment mechanism 40.

[0625] Reference Fig.26A -B, these are schematic diagrams of a system 660 according to some applications of the present invention, the system 660 including an annuloplasty structure 662 including an adjustment indicator 632 including an adjustment indicator band 666. Note that the structure 662 is similar to the annuloplasty ring structure 222 described herein, except that the structure 662 includes the band 666. The band 666 generally includes a flexible material, such as polyester and a radiopaque material, and generally provides an indication of contraction of the contraction member 226 and the structure 662. The portion of the contraction member 226 adjacent to the distal end 429 of the member 226 passes through the band 666. That is, as shown in FIG. Fig.26A -B, the adjustment mechanism 40 is coupled to the contraction member 226 at a first end thereof, and the indicator 632 is coupled to the contraction member 226 at a second end thereof. The flexible sleeve 26 defines a general body portion 750 of the annuloplasty ring structure 222.

[0626] The tape 666 has a width W22 of 1-5 mm, for example 3 mm, and a thickness of 0.1-0.5 mm.

[0627] For some applications of the present invention, adjustment indicator band 666 comprises a ribbon.

[0628] For some applications of the present invention, the adjustment indicator 632 is generally coupled to the main body portion of the implant. For example, the implant includes an annuloplasty ring structure having a main body portion (e.g., the flexible sleeve 26), and the indicator 632 is directly coupled to the main body portion of the annuloplasty ring structure. As shown, the indicator 632 is directly coupled to the outer surface of the main body portion of the annuloplasty ring structure.

[0629] Fig.26A The structure 662 is shown before the contraction member 226 is tightened. In this state, the band 666 is in a relaxed state and is not pressed against the flexible sleeve 26 (i.e., it is in an unstressed state). In the relaxed, unstressed state, the band 666 defines a longitudinal length L2 of 4-6 mm measured along the longitudinal axis of the band 666 from a first end of the band 666 to a second end of the band 666. In the relaxed, unstressed state of the band 666, the upper portion of the band 666, e.g., the top end of the band 666, is a distance Di3 of 2-4 mm from the flexible sleeve 26 (i.e., the main body of the structure 662).

[0630] like Fig.26B As shown, when the contraction member 226 is fully tightened by the adjustment mechanism 40 (i.e., when the tension level of the member 226 increases), the band 666 changes shape. That is, the band 666 is flattened, and at least a portion of the band 666 is pressed closer to and against the flexible sleeve 26. During the flattening of the band 666, as at least a portion of the band 666 is pressed against the flexible sleeve 26, the band 666 has a flattened and compressed longitudinal length L3 of 7-10 mm measured along the longitudinal axis of the band 666 from the first end of the band 666 to the second end of the band 666. In the flattened compressed state of the band 666, the upper portion of the band 666, such as the top end of the band 666, is closer to the flexible sleeve 26 (i.e., the main body of the structure 662) by a distance Di4 of 0-1 mm.

[0631] Note that the adjustment indicator band 666 may be used in combination with any annuloplasty structure described herein (eg, the annuloplasty ring structure 222, 611, 631, 641, 651, 711, 721, or any other annuloplasty structure described below).

[0632] Reference Fig.27A-B, these are schematic diagrams of a system 670 according to some applications of the present invention, the system 670 including an annuloplasty structure 672. Note that the structure 672 is similar to the annuloplasty ring structure 222 described herein, except that the structure 672 includes an adjustment indicator 632, which indicator 632 includes a deforming element 674, which includes first and second arms 676. The element 674 generally includes a flexible material, such as stainless steel, and includes a radiopaque material and generally provides an indication of contraction of the contraction member 226 and the structure 672. The portion of the contraction member 226 adjacent to the end 429 of the member 226 is coupled to the element 674. That is, a corresponding portion of the member 226 is coupled to (e.g., passes through) each arm 676 of the element 674. That is, as Fig.27A -B, the adjustment mechanism 40 is coupled to the retraction member 226 at a first end of the retraction member 226, and the indicator 632 is coupled to the retraction member 226 at a second end of the retraction member 226. The flexible sleeve 26 defines a general body portion 750 of the structure 672.

[0633] For some applications of the present invention, the adjustment indicator 632 is generally coupled to the main body portion of the implant. For example, the implant includes an annuloplasty ring structure having a main body portion (e.g., the flexible sleeve 26), and the indicator 632 is directly coupled to the main body portion of the annuloplasty ring structure. As shown, the indicator 632 is directly coupled to the outer surface of the main body portion of the annuloplasty ring structure.

[0634] Fig.27A The structure 672 is shown before the retraction member 226 is tightened. In this state, the element 674 is in a relaxed state and the arms 676 are spaced apart from each other.

[0635] like Fig.27B As shown, when the contraction member 226 is sufficiently tightened by the adjustment mechanism 40 (i.e., when the degree of tension in the member 226 increases), the element 674 changes shape to change the distance between the first and second arms 676. That is, the arms 676 are pulled closer toward each other, and the distance between the arms 676 decreases. Conversely, when the tension in the contraction member 226 decreases, the tension on the arms 676 decreases, and the arms 676 are stretched away from each other and return to their resting state.

[0636] Note that the deforming element 674 may be used in combination with any annuloplasty structure described herein (eg, annuloplasty ring structures 222, 611, 631, 641, 651, 711, 721, or any other annuloplasty structure described below).

[0637] Reference Fig.28A-B, these are schematic diagrams of a system 680 including an annuloplasty structure 682 according to some applications of the present invention. Note that structure 682 is similar to annuloplasty ring structure 222 described herein, except that the structure includes an adjustment indicator 632, which includes a container 684 and a plug 686. Container 684 is coupled to the outer surface of flexible sleeve 26. Container 684 and plug 686 include radiopaque materials and generally provide an indication of contraction of contraction member 226 and structure 682. The portion of contraction member 226 adjacent to end 429 of member 226 is coupled to plug 686. That is, as shown in FIG. Fig.28A -B, the adjustment mechanism 40 is coupled to the retraction member 226 at a first end of the retraction member 226, and the indicator 632 is coupled to the retraction member 226 at a second end of the retraction member 226. The flexible sleeve 26 defines a general body portion 750 of the structure 682.

[0638] Fig.28A The structure 682 is shown before the constriction member 226 is tightened. In this state, at least a majority of the plug 686 is arranged outside the space defined by the container 684.

[0639] like Fig.28B As shown, when the contraction member 226 is fully tightened by the adjustment mechanism 40 (i.e., when the tension level of the member 226 increases), the indicator 632 changes shape to position and fit the plug 686 within the space defined by the container 684. Conversely, when the tension of the contraction member 226 decreases, the plug 686 is moved away from the space defined by the container 684.

[0640] For some applications of the present invention, the adjustment indicator 632 is generally coupled to the main body portion of the implant. For example, the implant includes an annuloplasty ring structure having a main body portion (e.g., the flexible sleeve 26), and the indicator 632 (e.g., at least the reservoir 684) is directly coupled to the main body portion of the annuloplasty ring structure. As shown, the indicator 632 (e.g., at least the reservoir 684) is directly coupled to the outer surface of the main body portion of the annuloplasty ring structure.

[0641] Note that the container 684 and plug 686 may be used in combination with any annuloplasty structure described herein (eg, the annuloplasty ring structures 222, 611, 631, 641, 651, 711, 721, or any other annuloplasty structure described below).

[0642] Reference Fig.29A-B, these are schematic diagrams of a system 690 according to some applications of the present invention, the system 690 comprising an annuloplasty structure 692 comprising an adjustment indicator 632, the adjustment indicator 632 comprising an adjustment indication spring 694. Note that the structure 692 is similar to the annuloplasty ring structure 222 described herein, except that the structure 692 comprises a spring 694. The spring 694 generally comprises a flexible material such as stainless steel and a radiopaque material, and generally provides an indication of the contraction of the contraction member 226 and the structure 692. For some applications, the spring 694 comprises a folded spring with peaks and valleys, such as Fig.29A -B. For some applications, spring 694 comprises a helical spring. For some applications, spring 694 comprises a telescopic spring, such as a truncated cone scroll spring or any other telescopic spring. The flexible sleeve 26 defines a basic body portion 750 of the structure 692.

[0643] The portion of the retraction member 226 adjacent the distal end 429 of the member 226 is coupled to one end of a spring 694. The second end of the spring 694 includes a sleeve coupler 696 that fixedly couples the second end of the spring 694 to the flexible sleeve 26. Fig.29A -B, the adjustment mechanism 40 is coupled to the contraction member 226 at a first end of the contraction member 226, and the indicator 632 is coupled to the contraction member 226 at a second end of the contraction member 226.

[0644] Fig.29A The structure 662 is shown before the contraction member 226 is tightened. In this state, the spring 694 is in a relaxed, untensioned state. In the relaxed, untensioned state, the spring 694 defines a longitudinal length L5 of 2-4 mm measured from the first end of the spring 694 to the second end of the spring 694 along the longitudinal axis of the spring 694 at the leading edge of the coupler 696.

[0645] like Fig.29B As shown, when the contraction member 226 is fully tightened by the adjustment mechanism 40 (i.e., when the tension level of the member 226 increases), the spring 694 changes shape. That is, the spring 694 is longitudinally pulled and elongated. During the pulling process of the spring 694, the spring 694 has a pulled longitudinal length L5 of 6-8 mm measured from the first end of the spring 694 to the second end of the spring 694 along the longitudinal axis of the spring 694 at the leading edge of the coupling 696. For some applications of the present invention, the mark 25 is used as a reference point for how far the spring 694 is pulled.

[0646] For some applications of the present invention, the adjustment indicator 632 is generally coupled to the main body portion of the implant. For example, the implant includes an annuloplasty ring structure having a main body portion (e.g., the flexible sleeve 26), and the indicator 632 is directly coupled to the main body portion of the annuloplasty ring structure. As shown, the indicator 632 is directly coupled to the outer surface of the main body portion of the annuloplasty ring structure.

[0647] Note that the adjustment-indicating spring 694 may be used in combination with any of the annuloplasty structures described herein (eg, the annuloplasty ring structures 222 , 611 , 631 , 641 , 651 , 711 , or 721 ).

[0648] Reference Fig.30 , which is a schematic diagram of a system 700 including an implant configured to be delivered into a subject's heart according to some applications of the present invention. The implant includes an annuloplasty ring structure 711 (i.e., an implant, e.g., an annuloplasty band) including a flexible sleeve 26 and an adjustment mechanism 40 (as described above with respect to the annuloplasty ring structure 222, see Figure 1 ).

[0649] Structure 711 is similar to annuloplasty ring structure 222, except that contraction members 226 are coupled to flexible sleeve 26 in such a manner that at least a portion of contraction members 226 are helically arranged about a longitudinal axis A of flexible sleeve 26 of annuloplasty ring structure 222 in the absence of a twist or torsion applied to flexible sleeve 26. For some applications, at least 50%, such as at least 60%, of contraction members 226 are helically arranged about axis A. Flexible sleeve 26 defines a substantial body portion 750 of structure 711. Flexible sleeve 26 has a sidewall through which contraction members 226 are interwoven.

[0650] As shown, the retraction member 226 extends along a first portion 6331 defining the retraction portion of the flexible sleeve 26. The retraction member 226 extends at least along the retraction portion of the flexible sleeve 26 at a torsion angle of 170-190 degrees (e.g., 180 degrees) between the proximal and distal ends of the flexible sleeve 26.

[0651] like Fig.30 , the second end 429 of the retracting member 226 is located between 2.5 and 3.5 arcs from a position 624 along the flexible sleeve 26 where the retracting member 226 leaves the flexible sleeve 26 and travels to the adjustment mechanism 40. The twist angle between the second end 429 of the retracting member 226 and the position 624 is between 170 and 190 degrees, for example, 180 degrees. That is, the adjustment mechanism 40 is positioned at an angle between 140-180 degrees from the second end 429 of the retracting member 226, for example, between 155 and 175 degrees from the second end 429 of the retracting member 226.

[0652] Alternatively, after the structure 711 is bent in accordance with the shape of the valve ring, as shown in FIG. Fig.30 As shown in the following figure of FIG, the spiral connection of the contraction member 226 to the flexible sleeve 26 enables the structure 711 to assume the following configuration: the entire contraction member 226 is arranged along the inner periphery of the structure 711 (i.e., facing the center C) and not along any part of the outer periphery of the structure 711. As such, this configuration prevents the member 226 from becoming entangled with any anchors anchored to the outer periphery of the structure 711 through the flexible sleeve 26, as described above, for example with reference to Figure 3A -G and 4A-B.

[0653] Reference Fig.31A -C, these are schematic diagrams of a system 720 including an implant configured to be delivered into a subject's heart according to some applications of the present invention. The implant includes an annuloplasty ring structure 721 (i.e., an implant, e.g., an annuloplasty band) that includes a flexible sleeve 26 and an adjustment mechanism 40 (as described above with respect to the annuloplasty ring structure 222, see Figure 1 ). The flexible sleeve 26 defines a basic body portion 750 of the structure 721 .

[0654] The structure 711 is similar to the structure 651 described above with reference to FIG. 25, except that the flexible sleeve 26 is shaped to define first and second apertures 723 and 725 near the contraction member protection element 633. Generally, the apertures 723 and 725 are arranged near the connection point 635. A portion of the contraction member 226 exits the flexible sleeve 26 from the aperture 723 and reenters the cavity of the flexible sleeve 26 through the aperture 725. That is, the portion of the contraction member 226 exits the basic body portion 750 of the structure 721 through the first aperture 723 and reengages the basic body portion 750 of the structure 721 through the second aperture 725. Generally, the second aperture 725 is arranged at a distance L46 of 16-22 mm from the end wall 251 of the basic body portion 750 (e.g., the flexible sleeve 26). Generally, the diameter of the apertures 723 and 725 is 0.3-0.7 mm.

[0655] A majority of the contraction member 226 passes through the flexible sleeve 26 and is interwoven within and outside the lumen of the flexible sleeve 26 through a plurality of pass-through sites 722. The pass-through sites 722 are areas of the flexible sleeve 26 through which the contraction member 226 passes. In addition to the pass-through sites 722, the flexible sleeve 26 also defines apertures 723 and 725 that are larger than the openings provided by the sites 722. That is, the friction between the flexible sleeve 26 and the contraction member 226 at the apertures 723 and 725 is less than that at the pass-through sites 722. Thus, the structure 721 defines a first portion 726 having a first degree of friction between a basic body portion 750 (e.g., the flexible sleeve 26) and a first portion of the contraction member 226, and the structure 721 defines a second portion 724 having a second degree of friction between the basic body portion 750 (e.g., the flexible sleeve 26) and a second portion of the contraction member 226. The second degree of friction is less than the first degree of friction. Generally, when the contraction member 226 is not sufficiently tightened, as in Fig.31A -B, the second portion 724 defines a non-constricting member segment of the basic body portion 750 (eg, the flexible sleeve 26) between the first and second apertures 723 and 725.

[0656] like Fig.31B As shown, during the process of placing the flexible sleeve 26 around the valve annulus 240, the flexible sleeve 26 is bent and initially passively contracts to conform to the shape of the valve annulus 240. During the initial contraction process (i.e., contraction occurs passively in response to placing the flexible sleeve 26 around the valve annulus 240, rather than by actuation of the adjustment mechanism 40), the contracted shape of the flexible sleeve 26 does not accommodate the length ( Fig.31A 725). As such, a portion of the contraction member 226 is forced to pass through the apertures 723 and 725 slightly outside of the base body portion 750 (e.g., the flexible sleeve 26). The apertures 723 and 725 thereby accommodate and facilitate movement of the protruding portion of the contraction member 226 during bending of the flexible sleeve 26 in response to anchoring the flexible sleeve 26 along the annulus and prior to actuation of the adjustment mechanism 40. The apertures 723 and 725 enable the protruding portion of the contraction member 226 to exit the surface of the annuloplasty structure at a location of the structure along the base body portion 750 (e.g., the flexible sleeve 26) of the annuloplasty structure, but not at the adjustment mechanism 40, which is advantageous because the protruding portion of the contraction member 226 that exits along the base body portion 750 of the annuloplasty structure generally does not interfere with the function of the adjustment mechanism 40.

[0657] Fig.31C The structure 721 is shown in a fully contracted state, wherein the contraction member 226 is tensioned even at the second portion 724 of the structure 721 between the first and second apertures 723 and 725 .

[0658] In response to actuation of adjustment mechanism 40 to pull member 226 , retraction member 226 slides freely and with minimal friction through apertures 723 and 725 relative to sliding of retraction member 226 through site 722 , which occurs with greater friction.

[0659] Note that system 710 may be used in combination with any of the annuloplasty structures described herein (eg, annuloplasty ring structures 222, 611, 631, 641, 651, or 711).

[0660] Note that any of the devices or methods described herein may be used in combination with those described in PCT Application Publication No. WO 2014 / 064694, which is incorporated herein by reference in its entirety.

Claims

1. A device, comprising: An implant capable of percutaneous implantation, the implant capable of percutaneous implantation comprising: at least one small anchor, the at least one small anchor comprising (i) a small anchor head, and (ii) a small anchor tissue coupling element, and at least one large anchor, the at least one large anchor comprising (i) a large anchor head having the same width as the small anchor head, and (ii) a large anchor tissue coupling element that is larger than the small anchor tissue coupling element; The regulating device comprises: an adjustment mechanism coupled to the implant and configured to change a size of the implant upon actuation of the adjustment mechanism; and Lock: having a locked state wherein the lock inhibits actuation of the adjustment mechanism, having an unlocked state in which the adjustment mechanism can be actuated, and reversibly movable between the locked state and the unlocked state; longitudinal guide member; Connectors: coupled to the guide member, including a fastener that couples the connector to the adjustment device and is capable of being disconnected from the adjustment device in vivo, configured for transdermal delivery when coupled to the regulating device, and An unlocking mechanism is included, the unlocking mechanism being configured such that, when the joint is coupled to the adjustment device, actuation of the unlocking mechanism causes the lock to move between the locked state and the unlocked state. 2 . The device of claim 1 , wherein actuation of the unlocking mechanism causes the lock to move from the locked state to the unlocked state by pressing the unlocking mechanism on a depressible portion of the lock.

3. The apparatus of claim 2, wherein the unlocking mechanism comprises a pin disposed in a channel, and actuation of the unlocking mechanism to move the lock from the locked state to the unlocked state comprises sliding of the pin within the channel.

4. The apparatus of claim 3, wherein the fastener is shaped to define at least a portion of the channel.

5. The apparatus according to claim 4, wherein: The adjustment device is shaped to define a first thread, and The fastener is (i) shaped to define a second thread that couples the fastener to the adjustment device by engaging the first thread, and (ii) is capable of being disconnected from the adjustment device in vivo by the second thread being unthreaded from the first thread.

6. The apparatus of claim 2, wherein in the absence of depression of the depressible portion, the lock is biased to be in the locked state.

7. The apparatus of claim 1, further comprising an adjustment tool, wherein the adjustment tool: After the implant is implanted, it can be percutaneously advanced along the guide member to the joint. comprising an adjustment mechanism interface sized to interface with the adjustment mechanism, comprising a joint interface sized to receive the joint and comprising a force applying device, and Configured to: actuating the unlocking mechanism by applying a force to the unlocking mechanism with the force applying device when the joint is coupled to the adjustment device, so that the lock moves to the unlocked state, and The adjusting mechanism is actuated via the connection between the adjusting mechanism interface and the adjusting mechanism.

8. The apparatus of claim 7, wherein the tool is configured to decouple the connector from the adjustment device.

9. The apparatus of claim 8, wherein the adjustment mechanism interface and the joint interface are independently controllable.

10. The apparatus of claim 8, wherein the tool is configured to decouple the connector from the adjustment device independently of actuating the unlocking mechanism.

11. The apparatus of claim 7, wherein the force applying device is axially slidable relative to the joint and is configured to actuate the unlocking mechanism by applying an axial force to the unlocking mechanism.

12. The apparatus of claim 11, wherein: The connector includes a body shaped to define a passageway, The unlocking mechanism includes the channel, and a pin arranged in the channel and capable of sliding, and The force applying device is configured to actuate the unlocking mechanism by applying an axial force to the pin to slide the pin within the channel.

13. The apparatus of claim 12, wherein the body is shaped to define a side opening, the pin includes an appendage projecting laterally from the opening, and the joint interface is sized to be able to slide proximally of the body sufficient to allow the force applying device to reach the appendage.

14. The apparatus of claim 13, wherein a cross-section of a proximal portion of the body has a non-circular outer shape, and the tool is configured to decouple the connector from the adjustment device by applying torque to the body via the connector interface.

15. The apparatus of claim 13, wherein the distal portion of the joint interface is angled such that, in response to axial sliding of the joint interface over the proximal portion of the body, the joint interface automatically assumes a predetermined rotational orientation relative to the body.

16. The apparatus of claim 15, wherein the distal portion of the joint interface is angled such that, in the predetermined rotational orientation, the force applying device is aligned with the accessory.

17. The apparatus of claim 13, wherein the force applying device is angled such that, in response to axial sliding of the joint interface on the proximal portion of the body, the joint interface automatically assumes a predetermined rotational orientation relative to the body.

18. The apparatus of claim 17, wherein the distal portion of the joint interface is angled such that, in the predetermined rotational orientation, the force applying device is aligned with the accessory.

19. The apparatus according to claim 18, wherein: When the joint interface assumes the predetermined rotational orientation in which the force applying device is aligned with the attachment, the non-circular shape of the proximal portion of the body inhibits further rotation of the joint interface in response to further axial sliding of the joint interface on the body.

20. The apparatus of claim 13, wherein the body is shaped to define one or more shoulders, the shoulders being angled such that, in response to axial sliding of the joint interface over the shoulders, the joint interface automatically assumes a predetermined rotational orientation relative to the body.

21. The apparatus of claim 20, wherein a distal portion of the joint interface is angled such that, in the predetermined rotational orientation, the force applying device is aligned with the accessory.

22. A device for use with tissue of a subject, the device comprising a valvuloplasty structure, the valvuloplasty structure comprising: a sleeve having a first end and a second end, a bearing site, and including a sidewall defining a cavity from the first end to the second end, regulating mechanism, and Contraction components: having a first end coupled to the adjustment mechanism, having a first portion extending from the adjustment mechanism along the sleeve toward the second end to the bearing location, and having a second portion extending from the bearing location back toward the adjustment mechanism and the first end, at least one small anchor coupled to the contraction member and comprising (i) a small anchor head, and (ii) a small anchor tissue coupling element; at least one large anchor coupled to the contraction member and comprising (i) a large anchor head having the same width as the small anchor head, and (ii) a large anchor tissue coupling element that is larger than the small anchor tissue coupling element; The adjustment mechanism is configured to reduce a length of the sleeve between the first end and the second end by pulling the first portion of the retraction member such that the second portion of the retraction member progressively slides past the bearing site.

23. The apparatus of claim 22, wherein the first portion is interwoven through a side wall of the sleeve.

24. The apparatus of claim 22, wherein the second portion is interwoven through a side wall of the sleeve.

25. The apparatus of claim 22, wherein the first portion passes along the cavity.

26. The apparatus of claim 22, wherein the second portion passes along the cavity.

27. The apparatus of claim 22, wherein the retraction member has a second end fixedly coupled to the sleeve.

28. Apparatus according to any one of claims 22 to 27, wherein the sleeve has a cavity therein, the cavity defining the bearing site, the constriction member being slidable through the cavity.

29. An apparatus for treating tissue of a subject, the apparatus comprising: Percutaneous catheters; an implant sized to be advanced into the subject via the catheter; an anchor delivery channel shaped to define a lumen therethrough, the lumen having a diameter, and the channel being sized to be deployable within the catheter; at least one small anchor including a small anchor head coupled to a small anchor tissue coupling element and having a central longitudinal axis from the small anchor head to the small anchor tissue coupling element, the small anchor having a maximum transverse width less than a diameter of the lumen of the passageway; at least one large anchor, the large anchor comprising (i) a large anchor anchor head, the large anchor anchor head having the same width as the small anchor anchor head, and (ii) a large anchor tissue coupling element, the large anchor tissue coupling element being larger than the small anchor tissue coupling element and coupled to the large anchor anchor head, the large anchor having a central longitudinal axis from the large anchor anchor head to the large anchor tissue coupling element, the large anchor having a maximum transverse width greater than a diameter of the lumen of the passageway; and An anchor driver includes a driver head reversibly couplable to the large anchor anchor head, and a trunk sized to extend from the driver head through the lumen of the channel and out of the proximal end of the channel when the driver head is coupled to the large anchor anchor head.

30. The apparatus of claim 29, wherein: The large anchor is disposed at a distal portion of the channel, and at least the large anchor tissue coupling element is outside the lumen of the channel, The driving head is coupled to the large anchor head. The trunk extends proximally from the drive head through the lumen of the channel to the outside of the proximal end of the channel, The implant is shaped to define a cavity, The distal portion of the channel and the large anchor tissue coupling element are disposed within the lumen of the implant and are slidable with the implant through the catheter while within the lumen of the implant.

31. The apparatus of claim 29, wherein the lumen of the channel has a diameter of 2-3 mm.

32. The device of claim 29, wherein the large anchor has a maximum lateral width of 3-4 mm.

33. The apparatus of any one of claims 29-32, wherein the large anchor tissue engaging element is shaped to define a helix having a transverse width of 3-4 mm.

34. The apparatus of claim 33, wherein the large anchor head has a maximum transverse width of 2-3 mm.

35. The apparatus of claim 33, wherein the small anchor tissue engaging element is shaped to define a helix having a transverse width of 2-3 mm.

36. The apparatus of any one of claims 29-32, wherein the maximum lateral width of the macro-anchor is the maximum lateral width of the macro-anchor tissue coupling element.

37. The apparatus of claim 36, wherein the maximum transverse width of the large anchor head is less than the diameter of the lumen of the passageway.

38. The apparatus of claim 36, wherein the maximum transverse width of the large anchor head is greater than the diameter of the lumen of the passageway.

39. A device, comprising: An implant, comprising: contraction member; at least one small anchor coupled to the contraction member and comprising (i) a small anchor head, and (ii) a small anchor tissue coupling element; at least one large anchor coupled to the contraction member and comprising (i) a large anchor head having the same width as the small anchor head, and (ii) a large anchor tissue coupling element that is larger than the small anchor tissue coupling element; an actuatable adjustment mechanism coupled to the retraction member and configured to adjust a size of the body portion of the implant by applying tension to the retraction member when actuated; and An adjustment indicator is coupled to the contraction member and directly to the body portion of the implant and is configured to change shape based on a degree of tension of the contraction member.

40. The apparatus of claim 39, wherein the implant comprises an annuloplasty ring structure.

41. The apparatus of claim 39, wherein the body portion comprises a sleeve.

42. The apparatus of claim 39, wherein the adjustment indicator is directly coupled to an outer surface of the body portion of the implant.

43. The apparatus of any one of claims 39-42, wherein the adjustment indicator comprises a radiopaque element.

44. The apparatus of claim 43, wherein the implant comprises an annuloplasty structure and the retraction member is coupled to the annuloplasty structure via the radiopaque element.

45. The apparatus of claim 43, wherein: The radiopaque element comprises: Container; and a stopper shaped to fit within said container, The constriction member is coupled to the radiopaque element by coupling to the plug such that an increase in the degree of tension of the constriction member causes a change in the shape of the radiopaque element by positioning the plug within the container.

46. ​​The apparatus of claim 43, wherein the radiopaque element is disposed adjacent to the adjustment mechanism.

47. The apparatus of claim 43, wherein the adjustment mechanism is coupled to the contraction member at a first end of the contraction member, and wherein the radiopaque element is coupled to the contraction member at a second end of the contraction member.

48. The apparatus of claim 43, wherein the constriction member passes through the radiopaque element.

49. The apparatus of claim 48, wherein the implant comprises a valvuloplasty structure and the radiopaque element is coupled to the contraction member such that an increase in the degree of tension of the contraction member changes the shape of the radiopaque element by pressing the radiopaque element against the valvuloplasty structure.

50. The apparatus of claim 48, wherein the radiopaque element comprises a belt.

51. The apparatus of claim 48, wherein the strip has a width of 1-3 mm.

52. The apparatus of claim 50, wherein: When no tension is applied to the contraction member, the shape of the belt in an unstressed state has an unstressed longitudinal length measured along the longitudinal axis of the belt of 4-6 mm, and In response to an increase in the degree of tension of the contraction member, at least a portion of the band is pressed against the implant, assumes a compressed state, and has a compressed longitudinal length of 7-10 mm measured along the longitudinal axis of the band.

53. The apparatus of claim 43, wherein the radiopaque element comprises a tube surrounding a portion of the constriction member.

54. The apparatus of claim 53, wherein the radiopaque element is coupled to the contraction member such that an increase in the degree of tension of the contraction member causes the shape of the radiopaque element to change by compressing the tube.

55. The apparatus of claim 43, wherein the radiopaque element comprises a spring.

56. The apparatus of claim 55, wherein the radiopaque element is coupled to the contraction member such that an increase in the degree of tension of the contraction member causes a change in the shape of the radiopaque element by expanding the spring.

57. The apparatus of claim 55, wherein the spring comprises a truncated cone scroll spring.

58. The apparatus of claim 55, wherein the spring comprises a telescopic spring surrounding a portion of the retraction member.

59. The apparatus of claim 58, wherein the radiopaque element is coupled to the contraction member such that an increase in the degree of tension of the contraction member causes a change in shape of the radiopaque element by compressing the spring.

60. The apparatus of claim 43, wherein: The radiopaque element is shaped to define at least a first arm and a second arm, and The contraction member is coupled to the radiopaque element by coupling each of the first and second arms such that an increase in the degree of tension of the contraction member changes the shape of the radiopaque element by changing the distance between the first and second arms.

61. The apparatus of claim 60, wherein the first and second arms are pulled toward each other in response to an increase in the degree of tension in the contraction member.

62. The apparatus of claim 60, wherein the retraction member passes through respective portions of the first and second arms.

63. A device comprising an implant comprising: an annuloplasty structure having a basic body portion; a constriction member extending along at least a constriction portion of the annuloplasty structure; at least one small anchor coupled to the contraction member and comprising (i) a small anchor head, and (ii) a small anchor tissue coupling element; at least one large anchor coupled to the contraction member and comprising (i) a large anchor head having the same width as the small anchor head, and (ii) a large anchor tissue coupling element that is larger than the small anchor tissue coupling element; an actuatable adjustment mechanism coupled to the contraction member and configured to adjust the length of the annuloplasty structure by applying tension to the contraction member when actuated; and a contraction member protection element having a first end coupled to the base body portion of the annuloplasty structure and a second end coupled to the adjustment mechanism, The contraction member extends from the adjustment mechanism via the contraction member protection element to a substantial body portion of the annuloplasty structure.

64. The apparatus of claim 63, wherein the first end of the retraction member protection element is connected to the annuloplasty structure at a connection point that is at least 10 mm from either end of the annuloplasty structure.

65. An apparatus according to claim 63, wherein the valve forming structure includes a first sleeve, the first sleeve includes a tubular sidewall, the tubular sidewall defines a first cavity through the first sleeve, wherein the contraction member protection element includes a second sleeve, the second sleeve defines a second cavity through the second sleeve, and wherein a portion of the contraction member is arranged in the second cavity.

66. The apparatus of any one of claims 63-65, wherein the retracting member protection element comprises a belt, and wherein the retracting member passes through the belt.

67. Apparatus according to claim 66, wherein the strip has a width of 3-5 mm.

68. The apparatus of claim 66, wherein the belt width of the belt is 10 times greater than the width of the contracting member.

69. The apparatus of any one of claims 63-65, wherein the retraction member protection element comprises a spring, and wherein the retraction member is disposed within a cavity of the spring.

70. The apparatus of claim 69, wherein the spring comprises a telescopic spring.

71. The apparatus of claim 69, wherein the spring comprises a truncated cone scroll spring.

72. The apparatus of any one of claims 63-65, further comprising a catheter, and wherein: The first end of the retraction member protection element is connected to the annuloplasty structure at a connection point, The annuloplasty structure defines a central longitudinal axis, The implant has a delivery state wherein: The implant is capable of being percutaneously advanced through the catheter to an implantation site, and The adjustment mechanism is arranged on the central longitudinal axis, distal to the annuloplasty structure, and the retraction member protection element extends from the connection point alongside the annuloplasty structure to the adjustment mechanism, The implant has a deployed state wherein: The adjustment mechanism is arranged laterally of the central longitudinal axis, and Tensioning the retraction member through the adjustment mechanism moves the adjustment mechanism closer to the connection point and compresses the retraction member protection element.

73. The apparatus of claim 72, wherein the retracting member protection element has a longitudinal length of 10-15 mm when measured along a central longitudinal axis of the retracting member protection element before tensioning of the retracting member.

74. The apparatus of claim 72, further comprising a plurality of tissue anchors, wherein: The annuloplasty structure has a distal end and a distal portion extending between the connection point and the distal end, The plurality of tissue anchors includes (i) at least three tissue anchors disposed at a distal portion of the annuloplasty structure, and (ii) at least one tissue anchor disposed at a constriction portion of the annuloplasty structure.

75. A device comprising an implant comprising: A valvuloplasty structure comprising a first sleeve, the first sleeve comprising a tubular sidewall defining a first lumen through the first sleeve; a retraction member having a first portion extending along at least a retraction portion of the first sleeve of the annuloplasty structure, the retraction member exiting the first lumen at an exit point of the first lumen; at least one small anchor coupled to the contraction member and comprising (i) a small anchor head, and (ii) a small anchor tissue coupling element; at least one large anchor coupled to the contraction member and comprising (i) a large anchor head having the same width as the small anchor head, and (ii) a large anchor tissue coupling element that is larger than the small anchor tissue coupling element; an actuatable adjustment mechanism coupled to the contraction member at an end of the contraction member and configured to adjust the length of the annuloplasty structure by applying tension to the contraction member when actuated; and a second sleeve coupled to the first sleeve at an exit point of the constriction member from the first cavity, the second sleeve: defining a second lumen through the second sleeve, a second portion of the retraction member being disposed within the second lumen and extending to the adjustment mechanism, and The adjustment mechanism is coupled to the first sleeve.

76. An apparatus for use with a subject, the apparatus comprising: a catheter capable of being advanced transluminally into a subject; and An implant capable of being advanced through the catheter, the implant comprising: at least one small anchor, the at least one small anchor comprising (i) a small anchor head, and (ii) a small anchor tissue coupling element; at least one large anchor, the at least one large anchor comprising (i) a large anchor head having the same width as the small anchor head, and (ii) a large anchor tissue coupling element that is larger than the small anchor tissue coupling element; and A flexible sleeve defines a lumen having a proximal end, a distal end, and a central longitudinal axis therebetween, the implant being twistable about the longitudinal axis of the sleeve and being longitudinally slidable through the catheter when the sleeve is twisted about the longitudinal axis of the sleeve.

77. The apparatus of claim 76, wherein the torsion angle between the proximal and distal ends of the sleeve is 170-190 degrees.

78. The device according to claim 76 further includes a channel capable of longitudinally sliding through the catheter, wherein when the sleeve is twisted about the axis of the sleeve, the flexible sleeve of the implant covers the distal portion of the channel, and wherein when the sleeve covers the distal portion of the channel and the sleeve is twisted about the axis of the sleeve, the implant is capable of longitudinally sliding through the catheter together with the channel.

79. The apparatus of any one of claims 76-78, wherein the implant comprises: a retraction member extending longitudinally along the sleeve; and An actuatable adjustment mechanism is coupled to the retraction member and is configured to adjust a size of the implant by applying tension to the retraction member when actuated.

80. The apparatus of claim 79, wherein the contraction member has a first end coupled to the adjustment mechanism, and a second end coupled to a sleeve of the implant, wherein the adjustment mechanism twists from the second end of the contraction member at an angle between 155 and 175 degrees when the sleeve is twisted about the axis of the sleeve.

81. The device according to claim 79 further includes a channel capable of sliding longitudinally through the catheter, wherein the flexible sleeve of the implant covers the distal portion of the channel when twisted around the axis of the sleeve, and wherein the implant is capable of sliding longitudinally through the catheter together with the channel when the sleeve covers the distal portion of the channel while twisting around the axis of the sleeve.

82. The apparatus of claim 81 , wherein the implant rotates about a central longitudinal axis of the passage when the sleeve covers a distal portion of the passage while twisting about the axis of the sleeve.

83. The apparatus of claim 79, wherein the contraction member has a first end coupled to the adjustment mechanism and a second end coupled to a portion of a sleeve of the implant, and wherein the contraction member defines: a first longitudinal portion extending from the adjustment mechanism along a first longitudinal path, a second longitudinal portion extending to the portion of the sleeve of the implant along a second longitudinal path offset relative to the first longitudinal path, and An offset portion offsets the first and second longitudinal portions of the contraction member.

84. The apparatus of claim 83, wherein the offset portion extends along a stepped path.

85. The apparatus of claim 83, wherein the offset portion extends along a spiral path.

86. The apparatus of claim 83, wherein the sleeve of the implant is tubular, and wherein the first and second longitudinal portions are offset by a distance of 0.3-0.7 radians.

87. The apparatus of claim 83, wherein the first longitudinal portion and the second longitudinal portion are offset by a distance of 0.8-1.2 mm.

88. Apparatus comprising an implant comprising: an annuloplasty structure having a main body portion; a constriction member extending along at least a constriction portion of the annuloplasty structure; at least one small anchor coupled to the contraction member and comprising (i) a small anchor head, and (ii) a small anchor tissue coupling element; at least one large anchor coupled to the contraction member and comprising (i) a large anchor head having the same width as the small anchor head, and (ii) a large anchor tissue coupling element that is larger than the small anchor tissue coupling element; and an actuatable adjustment mechanism coupled to the contraction member and configured to adjust the length of the annuloplasty structure by applying tension to the contraction member when actuated, wherein The retraction member has a first end coupled to the adjustment mechanism and a second end coupled to a portion of the body portion of the implant, the retraction member defining: a first longitudinal portion extending from the adjustment mechanism along a first longitudinal path, a second longitudinal portion extending to the portion of the sleeve of the implant along a second longitudinal path offset relative to the first longitudinal path, and An offset portion offsets the first and second longitudinal portions of the contraction member.

89. The apparatus of claim 88, wherein the offset portion extends along a stepped path.

90. The apparatus of claim 88, wherein the offset portion extends along a helical path.

91. The apparatus of claim 88, wherein the body portion of the annuloplasty structure is tubular, and wherein the first and second longitudinal portions are offset by a distance of 0.3-0.7 radians.

92. The apparatus of any one of claims 88-91, wherein the first longitudinal portion and the second longitudinal portion are offset by a distance of 0.8-1.2 mm.

93. An apparatus for a subject, the apparatus comprising: a flexible sleeve capable of being advanced through the lumen into the subject and comprising a tubular sidewall that (i) defines a central longitudinal axis of the sleeve and (ii) defines a lumen having a distal end, a proximal end, and a length therebetween; Longitudinal contraction member: coupled to the flexible sleeve so as to tension the constriction member to reduce the lumen length, and coupled to the sidewall such that, in the absence of twisting of the sleeve about the longitudinal axis, at least a portion of the constriction member is helically arranged about the longitudinal axis; and at least one small anchor coupled to the contraction member and comprising (i) a small anchor head, and (ii) a small anchor tissue coupling element; At least one large anchor is coupled to the retraction member and includes (i) a large anchor head having the same width as the small anchor head, and (ii) a large anchor tissue coupling element that is larger than the small anchor tissue coupling element.

94. The apparatus of claim 93, wherein the contraction members are interwoven through the side walls.

95. The apparatus of claim 93, wherein the constriction member extends along at least a constriction portion of the sleeve.

96. The apparatus of claim 95, wherein the retraction member extends along at least the retraction portion of the sleeve at a twist angle of 170-190 degrees between the proximal and distal ends of the sleeve.

97. The apparatus of claim 93, further comprising an actuatable adjustment mechanism coupled to the retraction member and configured to adjust the size of the sleeve by applying tension to the retraction member when actuated.

98. The device of claim 97, wherein the contraction member has a first end connected to the adjustment mechanism, and a second end connected to a sleeve of the implant, wherein when the contraction member is spirally arranged around the axis of the sleeve, the adjustment mechanism twists from the second end of the contraction member at a twisting angle between 140-180 degrees.

99. An apparatus for a subject, the apparatus comprising: a base body portion capable of being advanced transluminally into a subject and having a distal end, a proximal end, and a length therebetween as measured along a longitudinal axis of the base body portion; Longitudinal contraction member: coupled to the basic body portion such that tensioning the contraction member reduces the length of the basic body portion, and coupled to the basic body portion such that in the absence of twisting of the basic body portion about the longitudinal axis, at least a portion of the constriction member is helically arranged about the longitudinal axis; and at least one small anchor coupled to the contraction member and comprising (i) a small anchor head, and (ii) a small anchor tissue coupling element; At least one large anchor is coupled to the retraction member and includes (i) a large anchor head having the same width as the small anchor head, and (ii) a large anchor tissue coupling element that is larger than the small anchor tissue coupling element.

100. An apparatus for a subject, the apparatus comprising: an annuloplasty structure having a basic body portion, the annuloplasty structure being capable of being advanced transluminally into a subject; and Longitudinal contraction member: coupled to the annuloplasty structure such that tensioning the constriction member reduces the length of a substantial body portion of the annuloplasty structure, interweaving through the basic body portion multiple times, wherein the base body portion of the annuloplasty structure defines a first aperture and a second aperture, and a portion of the retraction member exits the base body portion through the first aperture and reengages the base body portion through the second aperture; and at least one small anchor coupled to the contraction member and comprising (i) a small anchor head, and (ii) a small anchor tissue coupling element; At least one large anchor is coupled to the retraction member and includes (i) a large anchor head having the same width as the small anchor head, and (ii) a large anchor tissue coupling element that is larger than the small anchor tissue coupling element.

101. The apparatus of claim 100, wherein: The basic body portion includes a sleeve defining a cavity therethrough, The retraction member is interwoven inside and outside the lumen of the sleeve, and The sleeve defines a first aperture and a second aperture, and a portion of the retraction member exits the sleeve through the first aperture and reenters the lumen of the sleeve through the second aperture.

102. The apparatus of claim 100, wherein the second aperture is disposed at a distance of 16-22 mm from the end of the basic body portion.

103. An apparatus according to claim 100, wherein the basic main body portion is defined as a non-shrinkage member segment of the basic main body portion between the first hole and the second hole, and the friction of the non-shrinkage member segment is less than that of a segment of the basic main body portion adjacent to the first hole and the second hole and the non-shrinkage member segment.

104. The apparatus according to any one of claims 100-103 further comprises an actuatable adjustment mechanism connected to the contraction member and configured to adjust the size of the basic body portion of the valvuloplasty structure by applying tension to the contraction member when actuated.

105. The apparatus of claim 104, wherein the retraction member has a first end coupled to the adjustment mechanism, and a second end coupled to a substantial body portion of the annuloplasty structure.

106. The device according to claim 105 further includes a contraction member protection element, which has a first end connected to the basic main body part of the valve forming structure, and a second end connected to the adjustment mechanism, wherein the contraction member extends from the adjustment mechanism via the contraction member protection element to the basic main body part of the valve forming structure.

107. The apparatus of claim 106, wherein the first end of the retraction member protection element is connected to the annuloplasty structure at a connection point that is at least 10 mm from either end of the annuloplasty structure.

108. The apparatus of claim 107, wherein the first cavity and the second cavity are arranged in the vicinity of the connection point.

109. An apparatus for a subject, the apparatus comprising: an annuloplasty structure having a basic body portion, the annuloplasty structure being capable of being advanced transluminally into a subject; a longitudinal contraction member coupled to the annuloplasty structure such that tensioning the contraction member reduces the length of a substantial body portion of the annuloplasty structure; and at least one small anchor coupled to the contraction member and comprising (i) a small anchor head, and (ii) a small anchor tissue coupling element; at least one large anchor coupled to the contraction member and comprising (i) a large anchor head having the same width as the small anchor head, and (ii) a large anchor tissue coupling element that is larger than the small anchor tissue coupling element, wherein the annuloplasty structure defines a first portion such that a first degree of friction exists between the base body portion and the first portion of the constriction member, and The annuloplasty structure defines a second portion such that a second degree of friction exists between the base body portion and the second portion of the contraction member, the second degree of tension being less than the first degree of tension.

110. The apparatus of claim 109, wherein: The first portion of the contraction member is interwoven multiple times through the basic body portion of the first portion of the annuloplasty structure, and The second portion of the annuloplasty structure defines a first aperture and a second aperture in the base body portion of the annuloplasty structure, the second portion of the retraction member exiting the base body portion through the first aperture and reengaging the base body portion through the second aperture.

111. The apparatus of claim 109, wherein: The basic body portion includes a sleeve defining a cavity therethrough, The retraction member is interwoven inside and outside the lumen of the sleeve, and The sleeve defines a first aperture and a second aperture, and the second portion of the retraction member exits the sleeve through the first aperture and re-enters the lumen of the sleeve through the second aperture.

112. The apparatus of claim 109, wherein the second aperture is arranged at a distance of 16-22 mm from the end of the basic body portion.

113. The apparatus according to any one of claims 109-112 further comprises an actuatable adjustment mechanism connected to the contraction member and configured to adjust the size of the basic body portion of the valvuloplasty structure by applying tension to the contraction member when actuated.

114. The apparatus of claim 113, wherein the retraction member has a first end coupled to the adjustment mechanism, and a second end coupled to a substantial body portion of the annuloplasty structure.

115. The device according to claim 114 further includes a contraction member protection element, which has a first end connected to the basic main body part of the valve forming structure, and a second end connected to the adjustment mechanism, wherein the contraction member extends from the adjustment mechanism via the contraction member protection element to the basic main body part of the valve forming structure.

116. The apparatus of claim 115, wherein the first end of the retraction member protection element is connected to the annuloplasty structure at a connection point that is at least 10 mm from either end of the annuloplasty structure.

117. The apparatus of claim 116, wherein the first and second holes are arranged in the vicinity of the connection point.

118. Apparatus comprising: a tube having a distal end configured to be advanced into a patient's heart; an implant movable at least partially through the lumen of the tube, the implant comprising: an annuloplasty structure having a main body portion; a contraction member extending at least along the contraction portion of the annuloplasty structure and extending until 10-15 mm from the end of the main body portion; at least one small anchor coupled to the contraction member and comprising (i) a small anchor head, and (ii) a small anchor tissue coupling element; at least one large anchor coupled to the contraction member and comprising (i) a large anchor head having the same width as the small anchor head, and (ii) a large anchor tissue coupling element that is larger than the small anchor tissue coupling element; and an actuatable adjustment mechanism coupled to the contraction member and configured to adjust the length of the annuloplasty structure by applying tension to the contraction member when actuated, Wherein when the contraction member is completely disposed within the tube, a portion of the adjustment mechanism is disposed distally of a distal end of the tube.

119. The apparatus of claim 118, wherein the adjustment mechanism is movable relative to the base body portion.

120. An apparatus comprising: a tube having a distal end configured to be advanced into a patient's heart; an implant movable at least partially through the lumen of the tube, the implant comprising: an annuloplasty structure having a main body portion; a contraction member extending at least along the contraction portion of the annuloplasty structure and extending until 10-15 mm from the end of the main body portion; at least one small anchor coupled to the contraction member and comprising (i) a small anchor head, and (ii) a small anchor tissue coupling element; at least one large anchor coupled to the contraction member and comprising (i) a large anchor head having the same width as the small anchor head, and (ii) a large anchor tissue coupling element that is larger than the small anchor tissue coupling element; and an actuatable adjustment mechanism coupled to the contraction member and configured to adjust the length of the annuloplasty structure by applying tension to the contraction member when actuated, The distal-most portion of the contraction member is disposed distally of the distal end of the tube at a first distance therefrom, and a portion of the adjustment mechanism is disposed distally of the contraction member at a second distance therefrom, the second distance being greater than the first distance.

121. The apparatus of claim 120, wherein the adjustment mechanism is movable relative to the base body portion.

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