Apparatus for delivering lacing cord near valve annulus

Abstract

An apparatus for delivering a lacing cord near a valve annulus, in some embodiments, includes an elongate core having a main channel, a set of first channels, and at least one second channel, all channels passing through the core. The first channel accommodates a pull wire for triggering the anchor launcher and the second channel accommodates a portion of the cord. Support arms extend distally beyond the core, and an anchor emitter is mounted to each of the support arms. The support arm holds the distal end of the anchor emitter at a location distributed around the annulus of the valve. The anchor is launched to secure the cord, and the cord is tightened in a subsequent process.

Description

[0001] This application is a divisional application of Chinese patent application 2021103805591, filed on September 8, 2017, entitled “Device for delivering a tightening rope to the vicinity of the valve ring”. Divisional application 2021103805591 is a divisional application of Chinese patent application 2017800676158 (PCT / US2017 / 050716), filed on September 8, 2017, entitled “Device for delivering a tightening rope to the vicinity of the valve ring”.

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS

[0003] This application claims the benefit of U.S. Provisional Application No. 62 / 395,357, filed September 15, 2016, and U.S. Provisional Application No. 62 / 519,529, filed June 14, 2017, the entire contents of each of which are incorporated herein by reference. Background Art

[0004] Various methods for delivering and installing a cinching cord or valve ring to a heart valve annulus are described in U.S. Application Nos. 14 / 364,060 (published as US2014 / 0309730) and 14 / 895,711 (published as US2016 / 0120645), the entire contents of each of which are incorporated herein by reference. Summary of the invention

[0005] One aspect of the present invention relates to a first device for delivering a cinching cord near a valve annulus. The first device includes an elongated core, at least four support arms, and at least four anchor transmitters. The elongated core has: (a) a distal end; (b) a main channel passing through the core in a proximal-to-distal direction; (c) at least four first channels passing through the core in a proximal-to-distal direction, each of which is sized to accommodate a corresponding pull wire; and (d) at least one second channel passing through the core in a proximal-to-distal direction, which is sized to accommodate a first proximal portion and a second proximal portion of the cinching cord. The at least four support arms are mounted to the core and extend distally beyond the distal end of the core. Each of the anchor transmitters has a distal end, and each of the anchor transmitters is supported by a corresponding one of the support arms.

[0006] The support arms are configured to hold distal ends of the anchor transmitters at positions corresponding to the shape of the valve annulus, wherein the distal ends of the anchor transmitters are distributed around the periphery of the shape of the valve annulus.

[0007] Some embodiments of the first device further include at least four anchors, a lacing cord, and at least four pull wires. Each of the anchors is disposed in a corresponding one of the anchor launchers. The lacing cord has a distal loop portion, a first proximal portion, and a second proximal portion, wherein the first proximal portion and the second proximal portion are disposed in the at least one second channel, and wherein the anchor is connected to the distal loop portion of the lacing cord. Each of the pull wires is disposed in a corresponding one of the first channels, wherein each of the pull wires is operably connected to a corresponding one of the anchor launchers such that the corresponding anchor is launched by pulling the corresponding pull wire.

[0008] Some embodiments of the first device also include a plurality of support rings and a plurality of support rods. The support arm is fixed to the support ring and extends from the support ring in a distal direction. The support rod is fixed to the support ring, and the support rod extends from the support ring in a proximal direction. In these embodiments, the core has a plurality of third channels, which pass through the core in a proximal to distal direction and are sized to accommodate the support rods, and the support arm is installed to the core by inserting the support rods into the third channels. Optionally, these embodiments also include radiopaque materials distributed on the support rods in an asymmetric pattern.

[0009] In some embodiments of the first apparatus, the main channel is centered at the radial center of the core. In some embodiments of the first apparatus, each of the first channels and each of the at least one second channel are located at the same radial distance from the radial center of the core. In some embodiments of the first apparatus, each of the first channels includes an inner cavity, and each of the at least one second channel includes an inner cavity. In some embodiments of the first apparatus, each of the first channels and each of the at least one second channel are located at the same radial distance from the radial center of the core, each of the first channels includes an inner cavity, and each of the at least one second channel includes an inner cavity.

[0010] In some embodiments of the first device, the at least four support arms include at least eight support arms, the at least four first channels include at least eight first channels, and the at least four anchor transmitters include at least eight anchor transmitters. In some embodiments of the first device, the valve annulus is a mitral valve annulus. In other embodiments of the first device, the valve annulus is a tricuspid valve annulus.

[0011] Some embodiments of the first device also include an outer sleeve disposed around the core, the outer sleeve having a distal end. The outer sleeve can slide relative to the core between an extended position and a withdrawn position. When the outer sleeve is in the extended position, the support arm and the anchor transmitter are disposed within the outer sleeve. When the outer sleeve is in the withdrawn position, at least a portion of the support arm and the anchor transmitter extend distally beyond the distal end of the outer sleeve.

[0012] Some embodiments of the first device further include: a first sleeve disposed around the core, the first sleeve having a distal portion, wherein the first sleeve is slidable relative to the core between an extended position and a retracted position; and a removable second sleeve slidably disposed around the distal portion of the first sleeve. When the second sleeve is in the initial position, the support arm and the anchor transmitter are disposed within the second sleeve, and when the second sleeve is removed and the first sleeve is in the retracted position, the anchor transmitter is freely movable to a position corresponding to the shape of the valve annulus.

[0013] Another aspect of the present invention relates to a second device for delivering a lacing cord near a valve annulus. The second device includes an elongated core, at least a support arm, and at least eight anchor transmitters. The elongated core has: (a) a distal end; (b) a main channel passing through the core in a proximal-to-distal direction; (c) at least eight first channels passing through the core in a proximal-to-distal direction and located radially beyond the main channel, each of the first channels being sized to accommodate a corresponding pull wire; and (d) a plurality of second channels passing through the core in a proximal-to-distal direction and located radially beyond the main channel, each of the second channels being sized to accommodate a corresponding proximal portion of the lacing cord. The at least eight support arms are mounted to the core and extend distally beyond the distal end of the core. Each of the anchor transmitters has a distal end, and each of the anchor transmitters is supported by a corresponding one of the support arms. The support arms are configured to hold the distal ends of the anchor transmitters at positions corresponding to the shape of the valve annulus, wherein the distal ends of the anchor transmitters are distributed around the periphery of the shape of the valve annulus.

[0014] Some embodiments of the second device also include at least eight anchors, a lacing cord, and at least eight pull wires. Each of the anchors is disposed in a corresponding one of the anchor launchers. The lacing cord has a distal loop portion, a first proximal portion, and a second proximal portion, wherein the first proximal portion and the second proximal portion are disposed in a corresponding second channel of the second channel, and wherein the at least eight anchors are connected to the distal loop portion of the lacing cord. Each of the pull wires is disposed in a corresponding one of the first channels, and each pull wire is operably connected to a corresponding one of the anchor launchers, so that the corresponding anchor will be launched by pulling the corresponding pull wire.

[0015] Some embodiments of the second device also include a plurality of support rings and a plurality of support rods. The support arm is fixed to the support ring and extends from the support ring in a distal direction. The support rod is fixed to the support ring, and the support rod extends from the support ring in a proximal direction. In these embodiments, the core has a plurality of third channels, which pass through the core in a proximal to distal direction and are sized to accommodate the support rods, and the support arm is installed to the core by inserting the support rods into the third channels. Optionally, these embodiments also include radiopaque materials distributed on the support rods in an asymmetric pattern.

[0016] In some embodiments of the second apparatus, each of the first channels is located at the same radial distance from the radial center of the core. In some embodiments of the second apparatus, each of the first channels and each of the second channels are located at the same radial distance from the radial center of the core. In some embodiments of the second apparatus, each of the first channels includes an inner cavity, and each of the second channels includes an inner cavity.

[0017] Some embodiments of the second device also include a plurality of support rings, a plurality of support rods, and radiopaque material. The support arm is fixed to the support ring and extends from the support ring in a distal direction. The support rod is fixed to the support ring, and the support rod extends from the support ring in a proximal direction. The radiopaque material is distributed on the support rod in an asymmetric pattern. In these embodiments, the core has a plurality of third channels that pass through the core in a proximal to distal direction and are sized to accommodate the support rods, and the support arm is mounted to the core by inserting the support rods into the third channels. In these embodiments, each of the first channels and each of the second channels are located at the same radial distance from the radial center of the core, each of the first channels includes an inner cavity, and each of the second channels includes an inner cavity.

[0018] Some embodiments of the second device also include an outer sleeve disposed around the core, the outer sleeve having a distal end. The outer sleeve can slide relative to the core between an extended position and a retracted position. When the outer sleeve is in the extended position, the support arm and the anchor transmitter are disposed within the outer sleeve. When the outer sleeve is in the retracted position, at least a portion of the anchor transmitter and the support arm extend distally beyond the distal end of the outer sleeve.

[0019] Some embodiments of the second device further include: a first sleeve disposed around the core, the first sleeve having a distal portion, wherein the first sleeve is slidable relative to the core between an extended position and a retracted position; and a removable second sleeve slidably disposed around the distal portion of the first sleeve. When the second sleeve is in the initial position, the support arm and the anchor transmitter are disposed within the second sleeve, and when the second sleeve is removed and the first sleeve is in the retracted position, the anchor transmitter is freely movable to a position corresponding to the shape of the valve annulus.

[0020] Another aspect of the present invention relates to a third device for delivering a valve ring to the vicinity of the valve annulus. The third device includes an elongated core, at least four support arms, and at least four anchor transmitters. The elongated core has: (a) a distal end; (b) a main channel passing through the core in a proximal to distal direction; and (c) at least four lumens, which pass through the core in a proximal to distal direction. The size of each lumen is designed to accommodate a corresponding pull wire. The support arm is mounted to the core and extends distally beyond the distal end of the core. Each anchor transmitter has a distal end, and each anchor transmitter is supported by a corresponding one of the support arms. The support arm is configured to maintain the distal end of the anchor transmitter at a position corresponding to the shape of the valve annulus, wherein the distal ends of the anchor transmitters are distributed around the periphery of the shape of the valve annulus.

[0021] Some embodiments of the third device also include at least four anchors, a valve ring, and at least four pull wires. In these embodiments, each of the anchors is disposed in a corresponding one of the anchor launchers, and the anchor is connected to the valve ring. Each of the pull wires is disposed in a corresponding one of the inner cavities, and each of the pull wires is operably connected to a corresponding one of the anchor launchers, so that the corresponding anchor will be launched by pulling the corresponding pull wire.

[0022] Some embodiments of the third device also include a plurality of support rings and a plurality of support rods. In these embodiments, the support arm is fixed to the support ring and extends from the support ring in a distal direction. The support rod is fixed to the support ring, and the support rod extends from the support ring in a proximal direction. The core has a plurality of support channels, which pass through the core in a proximal to distal direction and are sized to accommodate the support rods, and the support arms are installed to the core by inserting the support rods into the support channels. Optionally, these embodiments also include radiopaque materials distributed on the support rods in an asymmetric pattern.

[0023] In some embodiments of the third apparatus, the main channel is centered at a radial center of the core, and each of the lumens is located at the same radial distance from the radial center of the core. In some embodiments of the third apparatus, the at least four support arms include at least eight support arms, the at least four lumens include at least eight lumens, and the at least four anchor launchers include at least eight anchor launchers.

[0024] Some embodiments of the third device also include an outer sleeve disposed around the core, the outer sleeve having a distal end. The outer sleeve can slide relative to the core between an extended position and a withdrawn position. When the outer sleeve is in the extended position, the support arm and the anchor transmitter are disposed within the outer sleeve. When the outer sleeve is in the withdrawn position, at least a portion of the support arm and the anchor transmitter extend distally beyond the distal end of the outer sleeve.

[0025] Some embodiments of the third device further include: a first sleeve disposed around the core, the first sleeve having a distal portion, wherein the first sleeve is slidable relative to the core between an extended position and a retracted position; and a removable second sleeve slidably disposed around the distal portion of the first sleeve. When the second sleeve is in the initial position, the support arm and the anchor transmitter are disposed within the second sleeve, and when the second sleeve is removed and the first sleeve is in the retracted position, the anchor transmitter is freely movable to a position corresponding to the shape of the valve annulus.

[0026] Another aspect of the present invention relates to a fourth device for mounting a lacing cord on a valve annulus or on tissue near the valve annulus. The fourth device includes a housing, an elongated core, a lacing cord, at least four anchors, and first and second cord extension segments. The elongated core is mounted relative to the housing. The core has (a) a distal end, (b) a proximal end, (c) a first lumen passing through the core in a proximal-to-distal direction, and (d) a second lumen passing through the core in a proximal-to-distal direction. The lacing cord has a distal ring portion, a first proximal portion, and a second proximal portion, wherein the first proximal portion of the lacing cord extends distally beyond the distal end of the core, passes through the first lumen, and extends proximally beyond the proximal end of the core, and wherein the second proximal portion of the lacing cord extends distally beyond the distal end of the core, passes through the second lumen, and extends proximally beyond the proximal end of the core. The anchor is configured to anchor the distal ring portion of the lacing cord into the valve annulus or into tissue near the valve annulus. The first rope extension segment has a distal end and a proximal segment, wherein the distal end of the first rope extension segment is connected to the first proximal portion of the tightening rope. The second rope extension segment has a distal end and a proximal segment, wherein the distal end of the second rope extension segment is connected to the second proximal portion of the tightening rope. The first inner cavity is sized to slidably accommodate the first proximal portion of the tightening rope and the first rope extension segment, and the second inner cavity is sized to slidably accommodate the second proximal portion of the tightening rope and the second rope extension segment. The tightening rope, the first and second rope extension segments, and the first and second inner cavities are configured so that after the distal ring portion of the tightening rope is anchored to the valve annulus or to the tissue near the valve annulus by the at least four anchors, the progressive movement of the shell in the proximal direction will (a) cause the core to move progressively in the proximal direction relative to the first and second proximal portions of the tightening rope and (b) cause the first and second rope extension segments to be progressively pulled into the first and second inner cavities, respectively.

[0027] In some embodiments of the fourth apparatus, the lacing cord, the first cord extension segment, and the second cord extension segment are continuous segments of a single cord.

[0028] Some embodiments of the fourth device also include at least one reel rotatably mounted relative to the housing. In these embodiments, the proximal segment of the first rope extension segment is wound around the at least one reel, and the proximal segment of the second rope extension segment is wound around the at least one reel. The tightening rope, the first and second rope extension segments, the first and second cavities, and the at least one reel are configured so that after the distal ring portion of the tightening rope is anchored to the valve annulus or to tissue near the valve annulus by the at least four anchors, the progressive movement of the housing in the proximal direction will cause the first and second rope extension segments to be progressively unwound from the at least one reel.

[0029] Some embodiments of the fourth device also include a locking member that selectively (a) prevents the at least one reel from rotating or (b) allows the at least one reel to rotate. In these embodiments, the at least one reel has spokes or markers that increase visibility of the rotation of the at least one reel, and the at least one reel is arranged relative to the housing so that at least a portion of the spokes or markers are visible from outside the housing. The lacing rope, the first rope extension segment, and the second rope extension segment are continuous segments of a single rope.

[0030] Another aspect of the present invention relates to a fifth device for mounting a lacing cord on a valve annulus or on tissue near the valve annulus. The fifth device includes a housing, at least one reel, an elongated core, a lacing cord, at least four anchors, at least four anchor transmitters, at least four support arms, and first and second cord extension segments. The at least one reel is rotatably mounted relative to the housing. The elongated core is mounted relative to the housing. The core has (a) a distal end, (b) a proximal end, (c) a first lumen passing through the core in a proximal-to-distal direction, and (d) a second lumen passing through the core in a proximal-to-distal direction. The lacing cord has a distal ring portion, a first proximal portion, and a second proximal portion, wherein the first proximal portion of the lacing cord extends distally beyond the distal end of the core, passes through the first lumen, and extends proximally beyond the proximal end of the core, and wherein the second proximal portion of the lacing cord extends distally beyond the distal end of the core, passes through the second lumen, and extends proximally beyond the proximal end of the core. The anchor is configured to anchor the distal ring portion of the tightening rope into the valve annulus or into tissue near the valve annulus. Each anchor transmitter is configured to launch a corresponding one of the at least four anchors into the valve annulus or into tissue near the valve annulus, and each anchor transmitter has a distal end. The support arm is mounted to the core and extends distally beyond the distal end of the core and supports the anchor transmitter. The support arm is shaped to keep the distal end of the anchor transmitter at a position corresponding to the shape of the valve annulus, wherein the distal end of the anchor transmitter is distributed around the periphery of the shape of the valve annulus. The first rope extension section has a distal end and a proximal section. The distal end of the first rope extension section is connected to the first proximal portion of the tightening rope, and the proximal section of the first rope extension section is wound on the at least one reel. The second rope extension section has a distal end and a proximal section, and the distal end of the second rope extension section is connected to the second proximal portion of the tightening rope. The proximal section of the second rope extension section is wound on the at least one reel. The first lumen is sized to slidably receive the first proximal portion and the first cord extension of the lacing cord, and the second lumen is sized to slidably receive the second proximal portion and the second cord extension of the lacing cord. The lacing cord, the first and second cord extensions, the first and second lumens, and the at least one reel are configured such that after the distal ring portion of the lacing cord is anchored to the valve annulus or to tissue near the valve annulus by the at least four anchors, progressive movement of the housing in the proximal direction will (a) cause the core to progressively move in the proximal direction relative to the first and second proximal portions of the lacing cord and (b) cause the first and second cord extensions to progressively unwind from the at least one reel and be progressively pulled into the first and second lumens, respectively.

[0031] In some embodiments of the fifth apparatus, the lacing cord, the first cord extension segment, and the second cord extension segment are continuous segments of a single cord. In some of these embodiments, the single cord is an ultra-high molecular weight polyethylene cord. In other embodiments of the fifth apparatus, the distal end of the first cord extension segment is secured to a first proximal portion of the lacing cord, and wherein the distal end of the second cord extension segment is secured to a second proximal portion of the lacing cord.

[0032] Some embodiments of the fifth device also include a locking member that selectively (a) prevents the at least one reel from rotating or (b) allows the at least one reel to rotate. In some of these embodiments, the locking member includes a removable pin that prevents the at least one reel from rotating when the removable pin is installed and allows the at least one reel to rotate when the pin is removed.

[0033] In some embodiments of the fifth apparatus, the at least one reel is arranged relative to the housing such that at least a portion of the at least one reel is visible from outside the housing. In some embodiments of the fifth apparatus, the at least one reel has spokes or markers that increase visibility of rotation of the at least one reel, and the at least one reel is arranged relative to the housing such that at least a portion of the spokes or markers is visible from outside the housing.

[0034] In some embodiments of the fifth device, the at least one reel includes a first reel on which the proximal segment of the first rope extension segment is wound and a second reel on which the second rope extension segment is wound. In some embodiments of the fifth device, the at least one reel includes a single reel having: (a) a first region on which the proximal segment of the first rope extension segment is wound; and (b) a second region on which the proximal segment of the second rope extension segment is wound, wherein the first region and the second region do not overlap. In some embodiments of the fifth device, the first lumen and the second lumen have smooth polymer walls.

[0035] Some embodiments of the fifth device also include at least four pull wires and a spring-loaded actuator. Each of the pull wires has a proximal end and a distal end, wherein the distal end of each pull wire is operably connected to a corresponding one of the anchor launchers, so that pulling the corresponding pull wire in the proximal direction causes the corresponding anchor launcher to launch the corresponding anchor. The spring-loaded actuator is configured to keep the proximal end of each pull wire stable before actuating the trigger and to pull the proximal end of each pull wire in the proximal direction when the trigger is actuated.

[0036] In some embodiments of the fifth apparatus, the at least four anchors include at least eight anchors, the at least four anchor transmitters include at least eight anchor transmitters, and the at least four support arms include at least eight support arms. In some embodiments of the fifth apparatus, the valve annulus is a mitral valve annulus. In other embodiments of the fifth apparatus, the valve annulus is a tricuspid valve annulus.

[0037] Some embodiments of the fifth device also include a locking member that selectively (a) prevents the at least one reel from rotating or (b) allows the at least one reel to rotate. In these embodiments, the at least one reel has spokes or markers that increase visibility of the rotation of the at least one reel, and the at least one reel is arranged relative to the housing so that at least a portion of the spokes or markers are visible from outside the housing. The tightening rope, the first rope extension segment, and the second rope extension segment are continuous segments of a single rope. In addition, the at least four anchors include at least eight anchors, the at least four anchor transmitters include at least eight anchor transmitters, and the at least four support arms include at least eight support arms.

[0038] In some embodiments of the fifth device, the at least one reel includes a single reel having: (a) a first region, on which a proximal segment of the first rope extension segment is wound; and (b) a second region, on which a proximal segment of the second rope extension segment is wound, and the first region and the second region do not overlap.

[0039] Some embodiments of the fifth device also include an outer sleeve arranged around the core, the outer sleeve having a distal end. The outer sleeve can slide relative to the core between an extended position and a withdrawn position. When the outer sleeve is in the extended position, the support arm and the anchor transmitter are arranged in the outer sleeve. And when the outer sleeve is in the withdrawn position, at least a portion of the support arm and the anchor transmitter extend distally beyond the distal end of the outer sleeve. Some embodiments of these embodiments also include a rack and pinion mounted relative to the housing, wherein the rack is connected to the outer sleeve so that actuation of the pinion causes the outer sleeve to move between the extended position and the withdrawn position.

[0040] Some embodiments of the fifth device further include: a first sleeve disposed around the core, the first sleeve having a distal portion, wherein the first sleeve is slidable relative to the core between an extended position and a retracted position; and a removable second sleeve slidably disposed around the distal portion of the first sleeve. When the second sleeve is in the initial position, the support arm and the anchor transmitter are disposed within the second sleeve, and when the second sleeve is removed and the first sleeve is in the retracted position, the anchor transmitter is freely movable to a position corresponding to the shape of the valve annulus.

[0041] Another aspect of the present invention relates to a first method for preventing tissue ingrowth from interfering with tightening a valve annulus using a lacing cord. The lacing cord has a distal ring portion, a first proximal portion, and a second proximal portion, the distal ring portion being disposed within a sleeve that promotes tissue ingrowth. The first method includes manipulating the lacing cord so that (a) the distal ring portion of the lacing cord disposed within the sleeve is located proximal to the valve annulus and (b) the first and second proximal portions of the lacing cord extend from the distal ring portion of the lacing cord in a proximal direction. The first method also includes anchoring the distal ring portion of the lacing cord to at least one of the valve annulus and tissue proximal to the valve annulus, and covering the first and second proximal portions of the lacing cord with a material that resists tissue ingrowth. The first method also includes, after the anchoring step and the covering step, waiting for tissue ingrowth to strengthen the bond between the distal ring portion of the lacing cord and at least one of the valve annulus and tissue proximal to the valve annulus. The first method also includes, after the waiting step, tightening the lacing cord by pulling the first and second proximal portions of the lacing cord so as to reduce the diameter of the valve annulus. The first method further comprises: after the tightening step, tightening the tightening cord so that the tightening cord maintains the valve annulus in a reduced diameter state. Preferably, the covering step comprises: sliding an elongated cord protector having a first lumen and a second lumen over first and second proximal portions of the tightening cord so that the first proximal portion of the tightening cord passes through the first lumen and the second proximal portion of the tightening cord passes through the second lumen.

[0042] Some embodiments of the first method further include: threading a first proximal portion of the lacing cord through the first lumen using a first threading cord, and threading a second proximal portion of the lacing cord through the second lumen using a second threading cord. In these embodiments, prior to the threading step, the first threading cord is disposed in the first lumen and the second threading cord is disposed in the second lumen. In these embodiments, in the sliding step, the first and second proximal portions of the lacing cord operate as guidewires over which the elongated cord protector slides, and the elongated cord protector slides to a position where a distal end of the elongated cord protector is adjacent to a distal loop portion of the lacing cord.

[0043] Some embodiments of the first method further include the step of removing the elongated cord protector after the waiting step and before the tightening step. Some embodiments of the first method further include the step of sliding the reinforcing member through a third lumen in a proximal to distal direction, the third lumen passing through the elongated cord protector, wherein the sliding step is performed after the anchoring step and before the covering step.

[0044] In some embodiments of the first method, the tightening step includes advancing the push tube in a distal direction over the first and second proximal portions of the lacing cord until the push tube reaches a distal loop portion of the lacing cord and then pressing the push tube in a distal direction while pulling the first and second proximal portions of the lacing cord in a proximal direction.

[0045] In some embodiments of the first method, the fastening step includes fastening two portions of the lacing tether together using at least one of a knot, a clip, and a crimp fastener. In some embodiments of the first method, in the anchoring step, the distal ring portion of the lacing tether is anchored by anchoring the sleeve to at least one of the valve annulus and tissue near the valve annulus using a plurality of anchors.

[0046] In some embodiments of the first method, in the anchoring step, the distal ring portion of the lacing tether is anchored by anchoring a plurality of anchors to at least one of the annulus and tissue near the annulus, each of the anchors having an eyelet through which the lacing tether is passed.

[0047] In some embodiments of the first method, the covering step includes sliding an elongated cord protector having at least one lumen over the first and second proximal portions of the lacing cord such that the first and second proximal portions of the lacing cord pass through the at least one lumen. In some of these embodiments, the first method further includes removing the elongated cord protector after the waiting step and before the lacing step.

[0048] Another aspect of the present invention relates to a sixth device for preventing tissue ingrowth from interfering with the operation of a cinching rope implanted in a subject's body. The cinching rope has a distal loop portion, a first proximal portion, and a second proximal portion. The sixth device includes a flexible, elongated body having a proximal end and a distal end. The elongated body has a first lumen extending between the proximal end and the distal end and a second lumen extending between the proximal end and the distal end. The first lumen is sized to slidably accommodate the first proximal portion of the cinching rope, and the second lumen is sized to slidably accommodate the second proximal portion of the cinching rope. The elongated body, the first lumen, and the second lumen are configured to facilitate slidable mounting of the elongated body on the first and second proximal portions of the cinching rope, so that the elongated body covers the first and second proximal portions of the cinching rope, wherein the first proximal portion of the cinching rope is disposed in the first lumen and the second proximal portion of the cinching rope is disposed in the second lumen. The elongated body prevents tissue ingrowth into the elongated body and, when the elongated body covers the first and second proximal portions of the lacing cord, the elongated body further prevents tissue ingrowth into the first and second proximal portions of the lacing cord.

[0049] Some embodiments of the sixth device also include a first string passing through the first lumen and extending distally beyond the distal end of the elongated body and a second string passing through the second lumen and extending distally beyond the distal end of the elongated body. Some of these embodiments also include a sterile envelope, and the elongated body, the first string passing through the first lumen, and the second string passing through the second lumen are all packaged inside the sterile envelope.

[0050] In some embodiments of the sixth apparatus, the first string is configured to pull the first proximal portion of the lacing cord into the first lumen, and the second string is configured to pull the second proximal portion of the lacing cord into the second lumen, such that the first and second proximal portions of the lacing cord can be operated as a guidewire over which the elongated body can slide to a position where the distal end of the elongated body is adjacent to the distal loop portion of the lacing cord. In some of these embodiments, the first string extends proximally beyond the proximal end of the elongated body, and the second string extends proximally beyond the proximal end of the elongated body.

[0051] In some embodiments of the sixth device, the elongated body is formed of at least one of polyurethane and silicone. In some embodiments of the sixth device, the length of the elongated body is between 35 cm and 65 cm, and the diameter is between 1 mm and 4 mm. In some embodiments of the sixth device, the length of the elongated body is between 45 cm and 55 cm. In some embodiments of the sixth device, the diameter of the elongated body is between 1.5 mm and 2.5 mm. In some embodiments of the sixth device, the length of the elongated body is between 45 cm and 55 cm, and the diameter is between 1.5 mm and 2.5 mm. In some embodiments of the sixth device, the diameter of the first lumen is between 0.2 mm and 1 mm, and the diameter of the second lumen is between 0.2 mm and 1 mm. In some embodiments of the sixth device, the elongated body has a third lumen, which is open at the proximal end, closed at the distal end, and extends through at least three quarters of the elongated body, and the third lumen is sized to slidably accommodate the reinforcement wire. In some embodiments of the sixth device, the elongated body has a third lumen that is open at the proximal end, closed at the distal end, and extends through at least three-quarters of the elongated body, and the diameter of the third lumen is between 0.2 mm and 1 mm. Some embodiments of the sixth device also include a radiopaque marker disposed near the distal end of the elongated body.

[0052] Some embodiments of the sixth device also include a first string passing through the first lumen and extending distally beyond the distal end of the elongated body and a second string passing through the second lumen and extending distally beyond the distal end of the elongated body. In these embodiments, the first string is configured to pull the first proximal portion of the lacing rope into the first lumen, and the second string is configured to pull the second proximal portion of the lacing rope into the second lumen, so that the first and second proximal portions of the lacing rope can be operated as a guide wire, and the elongated body can slide on the guide wire to a position where the distal end of the elongated body is adjacent to the distal loop portion of the lacing rope. In these embodiments, the elongated body is formed of at least one of polyurethane and silicone, the length of the elongated body is between 45 cm and 55 cm, the diameter is between 1.5 mm and 2.5 mm, the diameter of the first lumen is between 0.2 mm and 1 mm, and the diameter of the second lumen is between 0.2 mm and 1 mm. Some of these embodiments also include a radiopaque marker disposed near the distal end of the elongated body. In some of these embodiments, the elongate body has a third lumen that is open at the proximal end, closed at the distal end, and extends through at least nine-tenths of the elongate body, the third lumen having a diameter between 0.2 mm and 1 mm.

[0053] Another aspect of the present invention relates to a seventh device for delivering a valve ring or a tightening rope near the valve annulus. The seventh device includes an elongated core, at least four support arms, at least four anchor transmitters, an inflatable balloon, and at least one retainer rope. The elongated core has a distal end. The support arms are mounted to the core and extend distally beyond the distal end of the core. Each of the anchor transmitters has a distal end, and each of the anchor transmitters is supported by a corresponding one of the support arms. The inflatable balloon is disposed between the support arms and is configured so that when the balloon is inflated, the balloon will push the support arms away from each other. The at least one retainer rope is connected to the support arms and is arranged relative to the support arms to surround the balloon and prevent the balloon from slipping out from between the support arms.

[0054] In some embodiments of the seventh device, the at least one retainer string comprises a single retainer string that surrounds the balloon and prevents the balloon from sliding out between the support arms. In some of these embodiments, the single retainer string is connected to the support arms using at least one knot. In some of these embodiments, the single retainer string comprises at least one of silk, nylon, polypropylene, and polyester.

[0055] In some embodiments of the seventh apparatus, each support arm is enclosed in a sleeve, and the at least one retainer tether is connected to the support arm by threading the at least one retainer tether through a hole in each of the sleeves. In some embodiments of the seventh apparatus, each support arm is enclosed in a sleeve, and the at least one retainer tether is connected to the support arm by threading the at least one retainer tether through a hole in each of the sleeves and tying a knot at each of the sleeves. In some embodiments of the seventh apparatus, the at least one retainer tether includes at least two rope segments that together surround the balloon and prevent the balloon from sliding out from between the support arms.

[0056] Some embodiments of the seventh device further include a cinching cord and at least four anchors, wherein each anchor is disposed in a corresponding one of the anchor transmitters and connected to the cinching cord. In these embodiments, the support arm is configured to hold the distal ends of the anchor transmitters at positions corresponding to the shape of the valve annulus, wherein the distal ends of the anchor transmitters are distributed around the periphery of the shape of the valve annulus.

[0057] Some embodiments of the seventh device also include a valve ring and at least four anchors, each of which is disposed in a corresponding one of the anchor transmitters and connected to the valve ring. In these embodiments, the support arm is configured to hold the distal ends of the anchor transmitters at positions corresponding to the shape of the valve ring, wherein the distal ends of the anchor transmitters are distributed around the periphery of the shape of the valve ring.

[0058] In some embodiments of the seventh apparatus, the at least four support arms include at least eight support arms, and the at least four anchor transmitters include at least eight anchor transmitters.

[0059] Some embodiments of the seventh device also include an outer sleeve arranged around the core, the outer sleeve having a distal end. The outer sleeve can slide between an extended position and a withdrawn position relative to the core. When the outer sleeve is in the extended position, the support arm, the anchor transmitter, the balloon and the at least one retainer rope are arranged in the outer sleeve. When the outer sleeve is in the withdrawn position, at least a portion of the anchor transmitter, the at least one retainer rope and the support arm extends distally beyond the distal end of the outer sleeve.

[0060] Some embodiments of the seventh device also include a first sleeve disposed around the core, the first sleeve having a distal portion, wherein the first sleeve is slidable relative to the core between an extended position and a retracted position; and a removable second sleeve slidably disposed around the distal portion of the first sleeve. When the second sleeve is in the initial position, the support arm, the anchor transmitter, the balloon, and the at least one retainer string are disposed within the second sleeve. When the second sleeve is removed and the first sleeve is in the retracted position, the anchor transmitter is free to move to a position corresponding to the shape of the valve annulus.

[0061] Another aspect of the present invention relates to an eighth device for delivering a valve ring or tightening rope near a valve annulus. The eighth device includes an elongated core, at least four support arms, at least four anchor transmitters, a shaft, an inflatable balloon, and at least one retainer rope. The elongated core has a distal end and a channel passing through the core in a proximal to distal direction. The support arms are mounted to the core and extend distally beyond the distal end of the core. Each of the anchor transmitters has a distal end, and each of the anchor transmitters is supported by a corresponding one of the support arms. The shaft is slidably disposed in the channel, and the shaft has an inflation lumen. The inflatable balloon is mounted to the shaft and connected to the inflation lumen to allow the balloon to be inflated through the inflation lumen. By slidably adjusting the position of the shaft, the balloon can be moved to a first position between the support arms, and the balloon is configured so that when the balloon is inflated at the first position, the balloon will push the support arms away from each other. The at least one retainer tether is connected to the support arms and is arranged relative to the support arms to surround the balloon and prevent the balloon from sliding out from between the support arms when the balloon is in the first position.

[0062] In some embodiments of the eighth apparatus, the balloon can be moved to a second position by slidably adjusting the position of the shaft, the second position being within the channel and proximal to the support arm. In some embodiments of the eighth apparatus, the balloon can be moved to a second position by slidably adjusting the position of the shaft, the second position being distally beyond the anchor transmitter.

[0063] In some embodiments of the eighth apparatus, the at least one retainer string comprises a single retainer string that surrounds the balloon and prevents the balloon from sliding out between the support arms. In some of these embodiments, the single retainer string is connected to the support arms using at least one knot. In some of these embodiments, the single retainer string comprises at least one of silk, nylon, polypropylene, and polyester.

[0064] In some embodiments of the eighth apparatus, each support arm is enclosed in a sleeve, and the at least one retainer tether is connected to the support arm by threading the at least one retainer tether through a hole in each of the sleeves. In some embodiments of the eighth apparatus, each support arm is enclosed in a sleeve, and the at least one retainer tether is connected to the support arm by threading the at least one retainer tether through a hole in each of the sleeves and tying a knot at each of the sleeves. In some embodiments of the eighth apparatus, the at least one retainer tether includes at least two tether segments that together surround the balloon and prevent the balloon from sliding out from between the support arms.

[0065] Some embodiments of the eighth device also include a cinching cord and at least four anchors, each of which is disposed in a corresponding one of the anchor transmitters and connected to the cinching cord. In these embodiments, the support arm is configured to hold the distal ends of the anchor transmitters at positions corresponding to the shape of the valve annulus, wherein the distal ends of the anchor transmitters are distributed around the periphery of the shape of the valve annulus.

[0066] Some embodiments of the eighth device also include a valve ring and at least four anchors, each of which is disposed in a corresponding one of the anchor transmitters and connected to the valve ring. In these embodiments, the support arm is configured to hold the distal ends of the anchor transmitters at positions corresponding to the shape of the valve ring, wherein the distal ends of the anchor transmitters are distributed around the periphery of the shape of the valve ring.

[0067] In some embodiments of the eighth apparatus, the at least four support arms include at least eight support arms, and the at least four anchor transmitters include at least eight anchor transmitters.

[0068] Some embodiments of the eighth device also include an outer sleeve arranged around the core, the outer sleeve having a distal end. The outer sleeve can slide between an extended position and a withdrawn position relative to the core. When the outer sleeve is in the extended position, the support arm, the anchor transmitter, the balloon and the at least one retainer rope are arranged in the outer sleeve. When the outer sleeve is in the withdrawn position, at least a portion of the anchor transmitter, the at least one retainer rope and the support arm extends distally beyond the distal end of the outer sleeve.

[0069] Some embodiments of the eighth device also include a first sleeve disposed around the core, the first sleeve having a distal portion, wherein the first sleeve is slidable relative to the core between an extended position and a retracted position; and a removable second sleeve slidably disposed around the distal portion of the first sleeve. When the second sleeve is in the initial position, the support arm, the anchor transmitter, the balloon, and the at least one retainer tether are disposed within the second sleeve. When the second sleeve is removed and the first sleeve is in the retracted position, the anchor transmitter is free to move to a position corresponding to the shape of the valve annulus.

[0070] Another aspect of the present invention relates to a ninth device for delivering a valve ring or a tightening cord near a valve annulus. The ninth device includes an elongated core, at least four support arms, at least four anchor transmitters, a first shaft, an inflatable first balloon, a nose cone, a second shaft, and an inflatable second balloon. The elongated core has a distal end and a passage through the core in a proximal to distal direction. The support arms are mounted to the core and extend distally beyond the distal end of the core. Each anchor transmitter has a distal end, and each anchor transmitter is supported by a corresponding one of the support arms. The first shaft is disposed in the passage, and the first shaft has a first inflation lumen. The inflatable first balloon is mounted to the first shaft and connected to the first inflation lumen so as to allow the first balloon to be inflated via the first inflation lumen, and the first balloon is configured so that when the first balloon is inflated at a first position, the first balloon will push the support arms away from each other. The second shaft is slidably disposed in the passage, and the second shaft has a second inflation lumen. An inflatable second balloon is mounted to the second shaft and connected to the second inflation lumen to allow the second balloon to be inflated via the second inflation lumen, the second balloon being disposed distally beyond the first balloon.

[0071] In some embodiments of the ninth device, the first shaft is slidably disposed in the channel, and the first balloon is movable to a first position by slidably adjusting the position of the first shaft. In some of these embodiments, the first balloon is movable to a second position by slidably adjusting the position of the first shaft, the second position being located in the channel and proximal to the support arm.

[0072] Some embodiments of the ninth device also include an outer sleeve arranged around the core, the outer sleeve having a distal end. The outer sleeve can slide between an extended position and a withdrawn position relative to the core. When the outer sleeve is in the extended position, the support arm, the anchor launcher and the first balloon are arranged in the outer sleeve. When the outer sleeve is in the withdrawn position, at least a portion of the anchor launcher and the support arm extends distally beyond the distal end of the outer sleeve. Some of these embodiments also include a nose cone, the nose cone can be moved between a proximal position and a distal position, so that when the nose cone is in the proximal position and the outer sleeve is in the extended position, the nose cone is arranged at the distal end of the outer sleeve.

[0073] In some embodiments of the ninth apparatus including a nose cone, the second shaft extends distally beyond the nose cone, and the second balloon is positioned distally beyond the nose cone. In some embodiments of the ninth apparatus, the nose cone is mounted to the second shaft, and the nose cone is movable between a proximal position and a distal position by slidably adjusting a position of the second shaft.

[0074] In some embodiments of the ninth device including a nose cone, the first shaft is slidably disposed within the channel, and the first balloon is movable to a first position by slidably adjusting a position of the first shaft. The second shaft extends distally beyond the nose cone, and the second balloon is positioned distally beyond the nose cone. The nose cone is mounted to the second shaft, and the nose cone is movable between a proximal position and a distal position by slidably adjusting a position of the second shaft.

[0075] Some embodiments of the ninth device including the nose cone further include a third shaft slidably disposed within the channel. In these embodiments, the nose cone is mounted to the third shaft, and the nose cone can be moved between a proximal position and a distal position by slidably adjusting the position of the third shaft. In some embodiments of the ninth device, the nose cone is positioned distally beyond the second balloon.

[0076] Some embodiments of the ninth device further include a cinching cord and at least four anchors. In these embodiments, each of the anchors is disposed in a corresponding one of the anchor transmitters and connected to the cinching cord. The support arm is configured to hold the distal end of the anchor transmitter at a position corresponding to the shape of the valve annulus, wherein the distal ends of the anchor transmitters are distributed around the periphery of the shape of the valve annulus.

[0077] Some embodiments of the ninth device also include a valve ring and at least four anchors, wherein each of the anchors is disposed in a corresponding one of the anchor transmitters and connected to the valve ring. In these embodiments, the support arm is configured to hold the distal ends of the anchor transmitters at positions corresponding to the shape of the valve ring, wherein the distal ends of the anchor transmitters are distributed around the periphery of the shape of the valve ring.

[0078] In some embodiments of the ninth device, the at least four support arms include at least eight support arms, and the at least four anchor transmitters include at least eight anchor transmitters. In some embodiments of the ninth device, the valve ring is a mitral valve ring. In other embodiments of the ninth device, the valve ring is a tricuspid valve ring.

[0079] Another aspect of the present invention relates to a second method for implanting a valve ring or a tightening rope into a heart valve annulus or into tissue near the heart valve annulus. The valve annulus is located between the atrium and the ventricle of the heart, and the heart has an apex. The second method includes delivering a component into the atrium, wherein the component includes (a) a valve ring or a tightening rope, (b) a plurality of anchors connected to the valve ring or the tightening rope, and (c) a plurality of anchor launchers configured to launch the anchors into the valve annulus or into tissue near the valve annulus. The component is supported by a support member. The second method also includes positioning the component so that the valve ring or the tightening rope is adjacent to the valve annulus or adjacent to tissue near the valve annulus on the atrial side of the valve annulus. The second method also includes: advancing an inflatable balloon into the ventricle, wherein the balloon is supported by a support member; and inflating the balloon when the balloon is in the ventricle. The second method also includes adjusting the position of the balloon within the ventricle so that when the selected portion of the cardiac cycle occurs when the balloon is inflated, a force acting on the balloon will push the balloon toward the apex of the heart, which will push the support member toward the apex of the heart, which will push the valve ring or cinching tether toward the valve annulus or toward tissue near the valve annulus. The second method also includes: determining when the selected portion of the cardiac cycle occurs when the inflated balloon is in the adjusted position; and triggering the anchor transmitter so that the anchor transmitter launches the anchor into the valve annulus or into tissue near the valve annulus during the selected portion of the cardiac cycle when the inflated balloon is in the adjusted position.

[0080] In some embodiments of the second method, determining includes detecting when the support member is pulled in a distal direction. In some embodiments of the second method, advancing includes sliding a shaft in a distal direction relative to the support member, the inflatable balloon being mounted on the shaft. In some embodiments of the second method, positioning includes inflating an additional balloon between a plurality of support arms supporting the anchor transmitter such that the additional balloon pushes the support arms away from each other.

[0081] In some embodiments of the second method, the delivering comprises: (a) introducing the valve annulus or the cinching tethers, anchors and anchor transmitters into the atrium while the cinching tethers, anchors and anchor transmitters are retracted within the outer sleeve; (b) withdrawing the outer sleeve so that the cinching tethers, anchors and anchor transmitters extend beyond the distal end of the outer sleeve. In some embodiments of the second method, the valve annulus is a mitral valve annulus. In some embodiments of the second method, the valve annulus is a tricuspid valve annulus.

[0082] Another aspect of the present invention relates to a third method for implanting a valve ring or cinching tether into the tricuspid valve annulus or into tissue near the valve annulus. The third method includes delivering an assembly into the right atrium, wherein the assembly includes: (a) a valve ring or cinching tether; (b) a plurality of anchors connected to the valve ring or cinching tether; and (c) a plurality of anchor launchers, the anchor launchers being configured to launch anchors into the valve annulus or into tissue near the valve annulus, wherein the assembly is supported by a support member. The third method also includes: positioning the assembly so that the valve ring or cinching tether is adjacent to the valve annulus or adjacent to tissue near the valve annulus on the right atrial side of the valve annulus; and advancing an inflatable balloon in a collapsed state into the pulmonary artery. The balloon is supported by a support member. The third method also includes inflating the balloon while the balloon is in the pulmonary artery to fix the balloon in a position; and adjusting the position of the assembly while the balloon remains anchored in the position to press the valve ring or the cinching cord toward the valve annulus or toward tissue near the valve annulus. The third method also includes launching an anchor into the valve annulus or into tissue near the valve annulus after the adjustment, collapsing the balloon, and retracting the assembly.

[0083] In some embodiments of the third method, the pulmonary artery is a right pulmonary artery.

[0084] In some embodiments of the third method, the pulmonary artery is a left pulmonary artery.

[0085] In some embodiments of the third method, advancing includes sliding a shaft on which the inflatable balloon is mounted in a distal direction relative to the support member.

[0086] In some embodiments of the third method, positioning includes inflating an additional balloon between a plurality of support arms supporting the anchor transmitter such that the additional balloon urges the support arms away from each other.

[0087] In some embodiments of the third method, delivering includes introducing the valve annulus or tether, anchor, and anchor transmitter into the right atrium while the tether, anchor, and anchor transmitter are retracted within an outer sleeve.

[0088] Another aspect of the present invention relates to a tenth device for mounting a lacing cord on a valve annulus or on tissue near the valve annulus. The device includes a housing, an elongated core, a lacing cord, at least four support arms, at least four anchors, at least four anchor transmitters, at least one wire, and a push member. The elongated core is mounted relative to the housing. The core has: (a) a distal end; (b) at least one second channel that passes through the core in a proximal to distal direction; and (c) at least one fourth channel that passes through the core in a proximal to distal direction. The lacing cord has a distal ring portion, a first proximal portion, and a second proximal portion, wherein the first proximal portion of the lacing cord is slidably disposed within the at least one second channel and extends distally beyond the distal end of the core, and the second proximal portion of the lacing cord is slidably disposed within the at least one second channel and extends distally beyond the distal end of the core. The support arm is mounted to the core and extends distally beyond the distal end of the core. The anchors are configured to anchor the distal ring portion of the lacing cord into the valve annulus or into tissue near the valve annulus. Each of the anchor launchers is supported by a corresponding one of the support arms, and each of the anchor launchers is configured to launch a corresponding one of the anchors into the valve annulus or into tissue near the valve annulus. The at least one wire: (i) is slidably disposed within the at least one fourth channel, (ii) has a distal end that extends distally beyond the distal end of the core, and (iii) has a proximal end that extends proximally beyond the fourth channel. A pushing member is fixed to the distal end of the at least one wire, so that by pushing the proximal end of the at least one wire in the distal direction, the pushing member will be pushed in the distal direction. The lacing cord and the at least one second channel are configured so that after the distal ring portion of the lacing cord is anchored into the valve annulus or into tissue near the valve annulus by the at least four anchors, progressive movement of the housing in the proximal direction will cause the core to move progressively in the proximal direction relative to the first and second proximal portions of the lacing cord. The pushing member is configured such that after the distal ring portion of the tightening rope is anchored to the valve annulus or to the tissue near the valve annulus through the at least four anchors, pushing the pushing member in the distal direction will hinder the displacement of the anchors during the movement of the housing in the proximal direction.

[0089] In some embodiments of the tenth apparatus, the distal loop portion of the lacing cord is covered by a sleeve that promotes tissue ingrowth.

[0090] In some embodiments of the tenth apparatus, the pushing member has at least one passageway, and the first and second proximal portions of the lacing cord are slidably disposed in the at least one passageway.

[0091] In some embodiments of the tenth apparatus, the pushing member has a distal end and a proximal end and at least one passageway passing through the pushing member in a proximal-to-distal direction, and the first and second proximal portions of the lacing cord are slidably disposed in the at least one passageway.

[0092] In some embodiments of the tenth apparatus, the pushing member comprises a hollow cylinder arranged such that an axial axis of the hollow cylinder is parallel to the at least one wire, and the first and second proximal portions of the lacing cord are slidably disposed within the hollow cylinder.

[0093] In some embodiments of the tenth apparatus, the at least one second channel comprises a plurality of lumens, and each of the first proximal portion of the lacing cord and the second proximal portion of the lacing cord is slidably disposed within a respective one of the plurality of lumens. In some of these embodiments, the at least one wire comprises a plurality of wires, the at least one fourth channel comprises a plurality of channels, and each of the plurality of wires is slidably disposed within a respective one of the plurality of channels.

[0094] In some embodiments of the tenth device, the pushing member is configured such that after the distal ring portion of the tightening rope is anchored to the valve annulus or to tissue near the valve annulus by the at least four anchors, the tightening rope will be pressed against the valve annulus or tissue near the valve annulus by pushing the pushing member in the distal direction.

[0095] Some embodiments of the tenth device further include at least one anti-extrusion channel disposed distally beyond the distal end of the core, wherein the first and second proximal portions of the lacing cord are slidably disposed within the at least one anti-extrusion channel. In some of these embodiments, the at least one anti-extrusion channel extends to the pushing member before the distal ring portion of the lacing cord is anchored to the valve annulus or to tissue near the valve annulus by the at least four anchors. In some of these embodiments, the at least one anti-extrusion channel is supported by at least one support arm fixed to the core.

[0096] In some embodiments of the tenth device, the at least one second channel includes a plurality of lumens, and each of the first proximal portion of the lacing cord and the second proximal portion of the lacing cord is slidably disposed within a corresponding one of the plurality of lumens. The at least one wire includes a plurality of wires, the at least one fourth channel includes a plurality of channels, and each of the plurality of wires is slidably disposed within a corresponding one of the plurality of channels. The pushing member is configured such that after the distal ring portion of the lacing cord is anchored to the valve annulus or to tissue near the valve annulus by the at least four anchors, the lacing cord is pressed against the valve annulus or tissue near the valve annulus by pushing the pushing member in the distal direction. In some of these embodiments, the pushing member has a distal end and a proximal end and at least one passageway passing through the pushing member in a proximal-to-distal direction. The first proximal portion and the second proximal portion of the lacing cord are slidably disposed in the at least one passageway.

[0097] Another aspect of the present invention relates to a fourth method of attaching a lacing rope with a distal ring portion to a valve annulus or tissue near the valve annulus. The fourth method includes: delivering the distal ring portion of the lacing rope near the valve annulus using a percutaneous delivery tool, and launching at least four anchors into the valve annulus or into tissue near the valve annulus. The at least four anchors are configured to fix the distal ring portion of the lacing rope to the valve annulus or tissue near the valve annulus. The fourth method also includes: retracting the percutaneous delivery tool in a proximal direction after the at least four anchors have been launched, and pressing a push member in a distal direction so that the push member uses sufficient pressure to keep a portion of the lacing rope against the valve annulus or tissue near the valve annulus to prevent any of the at least four anchors from being displaced during the retraction of the percutaneous delivery tool.

[0098] In some embodiments of the fourth method, the at least four anchors include at least eight anchors. BRIEF DESCRIPTION OF THE DRAWINGS

[0099] Figure 1A and 1B are left and right side views, respectively, of an embodiment of an apparatus for mounting a cinching cord or valve ring to a heart valve annulus with the outer sleeve in an extended position;

[0100] Figure 2A and 2B 1 are respectively a left side view and a right side view of the embodiment when the outer sleeve is in the retracted position;

[0101] Figure 3 is a detailed view of the distal end of the embodiment of FIG. 1 when the outer sleeve is in the extended position;

[0102] Figure 4A yes Figure 3Detailed view of the core in an embodiment of the present invention;

[0103] Figure 4B Depicted Figure 3 how the support arms are secured to the core in the embodiment;

[0104] Figure 5A , 5B and 5C depict corresponding views of a portion of the embodiment of FIG. 1 that moves the outer sleeve between an extended position and a retracted position;

[0105] Fig. 6A is a detailed view of the distal assembly exposed from the outer sleeve in the embodiment of FIG. 1 ;

[0106] Figure 6B Depicted Fig. 6A , with additional sleeves covering certain components;

[0107] Fig. 7A Depicted after the distal end of the device has been inserted into the left atrium and the outer sleeve has been partially withdrawn Figure 3 equipment;

[0108] Figure 7B Depicted after the outer sleeve has been fully retracted Figure 3 equipment;

[0109] Figure 7C Depicts the balloon after it has been inflated Figure 3 equipment;

[0110] Fig.7D Depicted immediately after the anchor has been launched into the valve annulus Figure 3 equipment;

[0111] Fig. 8A Depicts the balloon after it has been collapsed and some components have been partially pulled back into the outer sleeve. Figure 3 equipment;

[0112] Figure 8B Depicted after these components have been further pulled back into the outer sleeve Figure 3 equipment;

[0113] Fig.9A yes Figure 5A Details of the proximal part of the;

[0114] Fig. 9B yes Fig.9A A detailed cross-sectional view of the central portion of the

[0115] Fig. 10A depicts a cord protector used to prevent tissue ingrowth;

[0116] Fig. 10B Depicted with a set of ropes Fig. 10A Rope protector;

[0117] Fig.11 is a flow chart of a method for preventing tissue ingrowth from interfering with valve annular tightening;

[0118] Fig. 12A depicts a cord protector sliding in a distal direction over a proximal portion of a cinching cord;

[0119] Fig. 12B Depicts the distal loop portion of the lacing rope after reaching it. Fig. 12A Rope protector;

[0120] Fig.13A Depicts the rope after the belay device has been retracted. Fig. 12A The cinching rope;

[0121] Fig. 13B Depicts the push tube after it has slid over the proximal portion of the lacing cord and reached the distal loop portion of the lacing cord. Fig. 12A The cinching rope;

[0122] Fig.14 Depicts a saccule attached to the Figure 3 A variation of the embodiment of;

[0123] Fig.15 Is used for Fig.14 A flowchart of a method of an embodiment of the present invention;

[0124] Fig.16 Depicted Fig. 6A A variation of the embodiment wherein the cinching cord has been replaced with a valve ring;

[0125] Fig.17 Another embodiment of a device for installing a lacing rope that reduces the risk of dislocation is depicted;

[0126] Fig.18 Depicts the following after the anchor has been implanted and retrieval of the device has begun. Fig.17 Embodiment:

[0127] Fig.19 Depicted with Fig.14 Another embodiment that is similar to the embodiment of , but uses a two-piece sleeve and omits the nose cone.

[0128] Various embodiments are described in detail below with reference to the drawings, wherein like reference numerals represent like elements. DETAILED DESCRIPTION

[0129] The present application describes methods and apparatus for delivering and installing a cinching cord or valve ring into a heart valve annulus. In a cinching cord embodiment, once the cinching cord is installed into the heart valve annulus using the apparatus and / or methods described herein, and after waiting for tissue ingrowth to occur, the cinching cord can be tightened to reduce the diameter of the valve annulus. These embodiments can be used to correct or improve various valve-related conditions (including but not limited to mitral regurgitation). In a valve ring embodiment, the valve ring is installed into the heart valve annulus to (a) stabilize the shape of the valve annulus and prevent the valve annulus from expanding, or (b) serve as a basis for an installable replacement valve. These embodiments can be used in the context of reducing valve regurgitation and heart valve replacement.

[0130] Figure 1A , 1B , 2A and 2B are views of a device 25 for delivering and installing a tightening cord or valve ring to a heart valve ring (e.g., a mitral valve ring or a tricuspid valve ring). In all four figures, the housing 40 is disposed on the proximal side of the device 25 and the outer sleeve 60 is disposed at the distal side of the device. More specifically, Figure 1A and 1B are respectively a left side view and a right side view of the device 25 when the outer sleeve 60 is in the extended position; Figure 2A and 2B 25 are left and right views of the device 25 when the outer sleeve 60 is in the retracted position. Figure 2A and 2B ), the distal assembly 70 (which includes the distal ring portion of the valve ring or the tightening rope) extends out through the distal end of the outer sleeve 60. When the outer sleeve 60 is extended (as shown in FIG. Figure 1A and 1B ), the distal assembly is retracted and disposed within the outer sleeve 60 and is therefore not visible in those figures. The extension and retraction of the outer sleeve 60 relative to the core 50 is controlled by the sleeve retractor 44, which will be described below.

[0131] Figure 3 1 is a detailed view of the distal end of the device 25 when the outer sleeve 60 is in its extended position. In this figure, the distal assembly 70 ( Figure 2A All components of the outer sleeve 60 are collapsed and contained in the outer sleeve 60. The preferred length of the outer sleeve 60 is 50 cm. In some embodiments, the outer diameter of the outer sleeve 60 is 22 French. Note that in alternative embodiments (e.g., the following discussion) Fig.17 / 18 embodiment), the single-piece outer sleeve 60 can be replaced by multiple sleeves.

[0132] Outer sleeve 60 is arranged around elongated core 50 so that outer sleeve can slide between extended position and withdrawn position relative to core.In certain embodiments, core 50 is made of flexible and incompressible polymer.In certain embodiments, the outer diameter of core 50 is 5.7mm.In alternative embodiments, the outer diameter of core is between 5.0mm to 6.5mm.The size of the gap between the inner diameter of the outer surface of core 50 and outer sleeve 60 is designed to facilitate the slidable relationship between outer sleeve 60 and core 50.Main channel 55 passes the center of core 50.In certain embodiments, the diameter of this main channel 55 is 3.7mm.In alternative embodiments, this diameter can change between 3.0mm to 4.5mm.

[0133] At least four support arms 72 are mounted to the core 50. The support arms 72 extend distally beyond the distal end of the core. Suitable materials for forming the support arms 72 include stainless steel, nitinol and other biocompatible metals. The support arms are flexible enough to collapse within the outer sleeve 60, but rebound to their original shape when extended distally beyond the limits of the outer sleeve 60.

[0134] At least four anchor launchers 74 are supported by corresponding support arms in the at least four support arms 72. Each of the anchor launchers has a distal end. Suitable designs of anchor launchers and anchors contained therein can be found in U.S. Applications 14 / 895,711 and 15 / 163,453, each of which is incorporated herein by reference. Anchors are provided in each of the anchor launchers 74. Each anchor launcher 74 has a pull wire trigger, and each pull wire 76 is operably connected to one of the anchor launchers 74 so that the corresponding anchor will be launched by pulling the corresponding pull wire.

[0135] Note that although Figure 3 Four support arms 72 and four anchor transmitters 74 are depicted, but it is more preferred to use at least eight support arms 72 and at least eight anchor transmitters 74 (e.g., 8 to 16 support arms and 8 to 16 anchor transmitters). Figure 3 Only four of the support arms and anchor launchers are depicted to make these components easier to see.

[0136] The lacing cord has a distal loop portion, a first proximal portion 84, and a second proximal portion 84. The distal loop portion 82 ( Fig. 6A82 of the lacing cord.

[0137] A shaft 106 is disposed within the main channel 55, the shaft 106 having an inflation lumen. An inflatable balloon 105 is mounted to the shaft 106 and connected to the inflation lumen to allow the balloon 105 to be inflated through the inflation lumen. The balloon 105 is configured such that when the outer sleeve 60 is withdrawn and the balloon 105 is inflated at a first position disposed between the support arms 72 (e.g., Figure 7B and 7C As can be clearly seen), the balloon 105 will push the support arms 72 away from each other to help move the support arms 72 to a position where the support arms 72 maintain the distal ends of the anchor transmitters 74 at a position corresponding to the shape of the valve annulus, wherein the distal ends of the anchor transmitters 74 are distributed around the periphery of the shape of the valve annulus.

[0138] Note that even without the balloon 105, the support arms 72 are shaped to hold the distal ends of the anchor transmitters 74 in a position corresponding to the shape of the valve annulus. However, because the support arms 72 may become entangled with each other when collapsed within the outer sleeve 60, the balloon 105 can be used to untangle the support arms. In addition, the balloon 105 reinforces the structure formed by the support arms 72 and the distal ring portion 82 of the lacing cord so that it becomes a relatively rigid structure that, in some preferred embodiments, fits very closely into the shape of the atrium.

[0139] Preferably, the shaft 106 is slidably disposed in the main channel 55, and the balloon 105 can be moved to a first position by slidably adjusting the position of the shaft 106. Optionally, the balloon 105 can be moved to a second position by slidably adjusting the position of the shaft 106, the second position being located in the main channel 55 and proximal to the support arm 72.

[0140] This embodiment also includes a nose cone 100 that can move between a proximal position and a distal position. When the nose cone 100 is in the proximal position and the outer sleeve 60 is in the extended position, the nose cone 100 is disposed at the distal end of the outer sleeve 60, such as Figure 3 shown.

[0141] In some embodiments, the nose cone 100 is mounted to a nose cone shaft 101 , and the nose cone is movable between a proximal position and a distal position by slidably adjusting the position of the nose cone shaft 101 . Figures 7A-7D The nose cone 100 is shown in a distal position. In an alternative embodiment, the nose cone is omitted entirely.

[0142] Figure 4A yes Figure 3 Detailed view of the core 50 in an embodiment of the present invention. The core 50 has a distal end and a main channel 55, which passes through the core in a proximal to distal direction and is centered on the radial center of the core 50. The core 50 also has at least four first channels 51, which pass through the core in a proximal to distal direction, and each first channel 51 is sized to accommodate a corresponding one of the pull wires 76. Preferably, each of the first channels 51 is an inner cavity. In some embodiments, the walls of these inner cavities 51 are made of the same material as the core 50. In alternative embodiments, the walls of these inner cavities 51 are lined with a smooth material such as PTFE.

[0143] The core 50 also has at least one second passage 52 that passes through the core in a proximal-to-distal direction and is sized to accommodate first and second proximal portions 84 of the lacing cord. Preferably, each proximal portion 84 of the lacing cord passes through its own separate second passage 52, and each of these second passages is sized to accommodate a respective proximal portion 84 of the lacing cord. However, in less preferred embodiments, both the first and second proximal portions 84 of the lacing cord may pass through a single second passage 52. Preferably, each of the second passages 52 is a lumen. In some embodiments, the walls of these lumens 52 are made of the same material as the core 50. In alternative embodiments, the walls of these lumens 52 are lined with a lubricious material such as PTFE.

[0144] Preferably, each of the first channels 51 and each of the at least one second channel 52 is located radially beyond the main channel 55. Optionally, each of the first channels 51 and each of the at least one second channel 52 is located at the same radial distance from the radial center of the core 50.

[0145] The core 50 also has a plurality of third channels 53 that pass through the core in a proximal to distal direction and are sized to accommodate the following combination of Figure 4B Described support rod 95. In some preferred embodiments, each of the first channels 51, each of the second channels 52, and each of the third channels 53 has a diameter of 0.45 mm.

[0146] Figure 4BA preferred method for mounting the support arm 72 to the core 50 is depicted. In this method, the support arm 72 is fixed to a plurality of support rings 90, and the support arm extends from the support rings in a distal direction. A plurality of support rods 95 are also fixed to the support rings, and the support rods extend from the support rings in a proximal direction. These support rods 95 can be formed of metal wires. Using this subassembly (which includes the support rings 90, the support rods 95 and the support arm 72), the support arm 72 can be mounted to the core 50 by inserting the support rods 95 into the third channel 53 of the core 50 so as to obtain Figure 3 The structure depicted.

[0147] The support rings 90 each have a plurality of holes 92, and these holes 92 are positioned so that when the support rod 95 has been inserted into the third channel 53 of the core 50, the holes 92 in the support ring will be aligned with the first channel 51 and the second channel 52 in the core 50. The support ring 90 also includes: at least four cutouts 93, which are sized and configured to support the support arms 72; and a plurality of cutouts 94, which are sized and configured to support the support rod 95.

[0148] Optionally, a radiopaque material (e.g., 80% platinum and 20% iridium, or other alternatives apparent to one skilled in the relevant art) may be added to the subassembly to aid in determining the position of the device during the procedure of installing the cinching cord or valve ring using fluoroscopy. Preferably, the radiopaque material is distributed in an asymmetric pattern. For example, a pair of radiopaque sleeves 98 may be disposed on one of the support rods 95, and a single radiopaque sleeve 98 may be disposed on another of the support rods 95. Using an asymmetric distribution of radiopaque material makes it easier to determine the orientation of the device during the process of installing the cinching cord or valve ring because different portions of the device will appear different under fluoroscopy. Of course, one skilled in the relevant art will appreciate that the radiopaque material may be distributed in a variety of different asymmetric patterns and still be useful for positioning and orientation purposes.

[0149] Back to Figure 3 , the first and second proximal portions 84 of the lacing cord are disposed in the at least one second channel 52 and can easily slide within the at least one second channel 52. In addition, each of the at least four pull wires 76 is disposed in a corresponding one of the first channels 51 and can easily slide within the first channel 51.

[0150] When the outer sleeve 60 is in the extended position (eg Figure 3 ), the support arm 72 and the anchor launcher 74 are disposed within the outer sleeve 60. However, when the outer sleeve 60 is in the retracted position, at least a portion of the support arm 72 and the anchor launcher 74 extend distally beyond the distal end of the outer sleeve 60 (as in Fig. 6A and6B (clearly seen in the figure).

[0151] Figures 5A-5C A portion of the device 25 is depicted that moves the outer sleeve 60 between an extended position (shown in Figures 1 and 3) and a retracted position (shown in Figures 2 and 6). Components with like numbers correspond to the same components discussed above in connection with Figures 1-4.

[0152] The device 25 includes a housing 40 that is sized to be held in a human hand and that has a plurality of controls 44a, 47 for operating the device 25. The housing may be formed of a thermoplastic material, metal, or any other suitable material. An elongated core 50 is mounted in a fixed spatial relationship relative to the housing 40, and the mounting of the core 50 to the housing 40 may be performed directly or through an intermediate component. An outer sleeve 60 (e.g., Figure 3 and 5A As shown) is arranged around the core 50, and the outer sleeve 60 can slide relative to the core 50 between an extended position and a retracted position.

[0153] In the illustrated embodiment, the sleeve withdrawer 44 is responsible for moving the outer sleeve 60 relative to the core 50. This is achieved using a rack-pinion assembly including a rack 44r and a pinion 44p. The steering control assembly 42 (which preferably promotes the medial deflection and frontal deflection of the catheter shaft and the rotation relative to the housing 40) is fixed to the distal end of the rack 44r, and the outer sleeve 60 is fixed to the distal end of the steering control assembly 42. As a result, the outer sleeve 60 will track the movement of the rack 44r. The clockwise rotation of the actuator 44a will cause the pinion 44p to rotate in a clockwise direction, which will cause the rack 44r to move in a proximal direction relative to the housing 40. Preferably, when the locking pin 44k is inserted, the locking pin 44k prevents the rack 44r from moving, which prevents the inadvertent withdrawal of the outer sleeve 60 during the device insertion.

[0154] Since the core 50 is in a fixed spatial relationship relative to the housing, movement of the rack 44r in the proximal direction will cause the outer sleeve 60 to slide in the proximal direction relative to the core 50. This will cause the outer sleeve 60 to move from the extended position (as shown in Figures 1 and 3) to the retracted position shown in Figures 2 and 6A.

[0155] Fig. 6A 7 is a detailed view of the distal assembly 70, which has been exposed from the outer sleeve 60 due to the withdrawal of the outer sleeve 60, so that the distal assembly 70 extends distally beyond the distal end of the outer sleeve 60. In this embodiment, the distal assembly 70 includes ten anchor launchers 74, each of which is supported by its own independent support arm 72. In some embodiments, the support arm 72 is mounted to the core 50, as described above in conjunction with Figure 3-4. The support arms are shaped so that when the outer sleeve 60 is in the retracted position, the support arms 72 hold the distal ends of the anchor transmitters 74 in a position corresponding to the shape of the valve annulus, wherein the distal ends of the anchor transmitters 74 are distributed around the periphery of the shape of the valve annulus (see also Figure 7C ).

[0156] Notice, Fig. 6A The distal ring portion 82 of the lacing tether in the embodiment can be circular in shape, which is suitable when the lacing tether is installed on a circular valve annulus. In an alternative embodiment, when the lacing tether is installed on a valve annulus with a different shape (e.g., a D-shaped mitral valve annulus), the support arm 72 is pre-formed so that the distal end of the anchor transmitter 74 will be distributed around the periphery of the valve annulus with a different shape.

[0157] Preferably, the support arms 72 are shaped and sized to fit the anatomy of the individual patient so that when the outer sleeve 60 is withdrawn, the distal ring portion 82 of the cinch cord will be opened by the support arms 72 and deployed around the valve annulus so that it is ready in the correct position to fire the anchor with minimal adjustment. This can be achieved, for example, by designing the 3D shape of the support arms 72 so that they each extend from the core 50 at a predetermined angle.

[0158] The desired shape of the support arm 72 and the circumference of the distal ring portion 82 of the tightening rope can be determined by converting a CT scan of the patient into a 3D CAD file. The support arms 72 can then be formed so that they will keep the distal ring portion 82 of the tightening rope in a configuration that matches the target valve ring. A preferred method of achieving this is to insert the anchor transmitter 74 into a fixture that holds the distal end of the anchor transmitter 74 in a position that matches the valve ring in the CAD file. The assembly including the support ring 90, the support rod 95 and the support arm 72 is then attached to the anchor transmitter 74 (e.g., using welding or a suitable adhesive). The fixture also holds the support rod 95 in a position that provides an appropriate angle between the support rod 95 and the support arm 72. The assembly (with the anchor transmitter 74 attached) is then heated to assume the shape that is being applied to it by the fixture. Optionally, the support arm can be made of a shape memory material, such as nitinol.

[0159] The lacing cord has a distal loop portion 82, a first proximal portion 84, and a second proximal portion 84. The distal loop portion 82 of the lacing cord is preferably surrounded by a sleeve 86 made of a material (e.g., braid) that promotes tissue ingrowth. As described above, the anchor disposed within the anchor launcher 74 is connected to the distal loop portion 82 of the lacing cord, and the anchor launcher 74 is configured so that by pulling the corresponding pull wire 76, the corresponding anchor will be launched.

[0160] Figure 6BSimilar to Fig. 6A (like reference numerals correspond to like features), except that Figure 6B Also shown is a set of sleeves 79, 89 which are shown in the figure for clarity. Fig. 6A Each of the anchor launchers 74 is supported by one of the support arms 72 and actuated by one of the pull wires 76. In order to facilitate smoother opening of the support arms 72, Figure 6B The configuration shown preferably encompasses support arms 72 and pull wires 76 that terminate in sleeves 79 at each individual anchor transmitter 74. Figure 6B In an embodiment, each anchor launcher 74 will have a sleeve 79, and the support arm 72 and pull wire 76 for that anchor launcher 74 will pass through the center of the corresponding sleeve 79. In some embodiments, these sleeves 79 are made of clear shrink tubing, the inner diameter of which (after shrinking) is large enough so as not to interfere with the slidability of the pull wire 76 within the sleeve 79. In alternative embodiments, the sleeves 79 can be made of other polymer materials with similar inner diameters.

[0161] Preferably, an additional sleeve 89 is provided and through which the proximal portion 84 of the lacing cord passes. Sleeve 89 is similar to sleeve 79 discussed above and is sized to have an inner diameter large enough not to interfere with the slidability of the proximal portion 84 of the lacing cord within sleeve 89.

[0162] In some embodiments, retainer tether 78 is connected to support arms 72 and arranged relative to support arms 72 such that when balloon 105 is positioned between support arms 72 and inflated (e.g., Fig.7D As shown), the retainer rope 78 will surround the balloon 105 and prevent the balloon 105 from sliding out from between the support arms 72.

[0163] At least one knot may be used to connect the retainer string 78 to the support arm 72. In some embodiments, the retainer string 78 comprises a silk suture. In alternative embodiments, the retainer string 78 comprises a polymer (eg, nylon, polypropylene, polyester, etc.) string.

[0164] In some preferred embodiments, as described above, the support arm 72 is enclosed in a sleeve 79, and the retainer string 78 is connected to the support arm 72 by threading the retainer string 78 through a hole in each of the sleeves 79 and tying a knot at each of the sleeves 79. For example, this can be achieved by using a continuous surgical silk suture or polymer string, which is sequentially connected between each support arm 72 and its adjacent neighbor. The retainer string 78 can be attached to the support arm 72 by the assembler piercing each sleeve 79 with an integrated needle of a surgical suture, which will ultimately serve as the retainer string 78. After the puncture is made, the retainer string 78 is passed through the puncture and fastened to the sleeve 79 using a knot (e.g., an overhand knot). The assembler then continues to the next support arm 72 and sleeve 79 and repeats the same process, eventually returning to the first support arm 72 and sleeve 79. When using this process to connect the retainer cord 78 to the support arm 72, it is preferred to ensure that there are no knots surrounding any of the pull wires (so as not to interfere with the pulling ability of the pull wires).

[0165] In an alternative embodiment (not shown), the single retainer cord 78 attached to each support arm 72 may be replaced with two or more shorter retainer cord segments that together collectively surround the balloon and prevent the balloon from sliding out between the support arms.

[0166] Figures 7A-7D Depicted is the installation of a cinching cord onto the mitral valve annulus of a human subject at successive time stages using the embodiments of FIGS. 1-6 described above. In this example, the distal end of the device 25 is passed through the subject's jugular vein and superior vena cava into the right atrium of the subject's heart 30 with the outer sleeve 60 in its extended position (as shown in FIG. 1 ). The distal tip is then passed through a puncture in the septum and into the subject's left atrium 32 using any conventional method.

[0167] Fig. 7A The device is depicted after the distal end of the device has reached the left atrium 32 and the outer sleeve 60 has been partially withdrawn. The anchor transmitter 74 and the distal loop portion 82 of the lacing tether (which is disposed inside the sleeve 86) extend distally beyond the distal end of the outer sleeve 60. The nose cone 100, mounted on the shaft 101, is lowered into the left ventricle 33 of the subject's heart. Note that at this point in the sequence, only a portion of the support arm 72 extends distally beyond the distal end of the outer sleeve 60, and the distal loop portion of the lacing tether (within the sleeve 86) remains partially collapsed.

[0168] Figure 7BThe device is depicted after the outer sleeve 60 has been fully withdrawn. The anchor transmitter 74, the distal loop portion of the lacing cord (which is disposed inside the sleeve 86), the support arm 72, the end of the pull wire 76, the balloon 105, and the balloon retainer 78 now all extend distally beyond the distal end of the outer sleeve 60. At this point, the spring action of the support arm 72 has significantly opened the distal loop portion of the lacing cord (within the sleeve 86).

[0169] Figure 7C The device is depicted after the balloon 105 has been inflated. The balloon retainer 78 prevents the balloon 105 from sliding out from between the support arms 72. The anchor transmitter 74, the distal ring portion of the tightening line (within the sleeve 86), the support arm 72, the end of the pull wire 76, the balloon 105 and the balloon retainer 78 are all maintained distally beyond the distal end of the outer sleeve 60. At this point, the balloon 105 has pushed the support arms away from each other to help move the support arms 72 to a position in which the support arms hold the distal ends of the anchor transmitters 74 in a position corresponding to the shape of the valve annulus, wherein the distal ends of the anchor transmitters 74 are distributed around the periphery of the shape of the valve annulus. Preferably, the support arms 72 have been preformed (as described above in conjunction with Fig. 6A As described above), no anchor transmitter 74 will be positioned on or near the AV node to prevent potential damage to the node.

[0170] The distal ends of the anchor launchers 74 are pressed against the valve annulus, and after proper positioning has been confirmed (e.g., using fluoroscopy), the anchor launchers 74 are triggered by pulling the proximal ends of the pull wires 76. This causes each of the anchor launchers 74 to launch its anchor into the valve annulus. Preferably, all of the anchor launchers 74 are triggered simultaneously. This is preferred because the structural shape of the support arm 72 determines the position and shape of the distal ring portion 82 of the tightening cord around the valve annulus before the anchor is launched. (In contrast, once the distal ring portion 82 is disconnected from the support arm 72, it may be difficult to control the shape of the implant. Therefore, in an alternative embodiment in which the anchors are launched sequentially rather than simultaneously, the position of each anchor launcher 74 may need to be adjusted prior to launching, which may be very challenging.)

[0171] Fig.7D The device is depicted after the anchors 75 have been launched into the valve annulus. At this point in the sequence, the anchors 75 have been deployed and they hold the distal ring portion 82 of the lacing tether (within the sleeve 86) to the valve annulus. The proximal portion 84 of the lacing tether remains connected to the distal ring portion of the lacing tether, but the delivery system (e.g., support arm 72, anchor launcher 74, etc.) is no longer connected to the distal ring portion 82 of the lacing tether.

[0172] Next, the balloon 105 is collapsed and the balloon 105, support arm 72 and anchor launcher 74 are pulled back into the outer sleeve 60, as shown in FIG. Fig. 8A These components are then further pulled back into the outer sleeve 60, as shown. Figure 8B The anchor 75 continues to retain the distal ring portion 82 of the lacing tether (within the sleeve 86) to the annulus 35, and the proximal portion 84 of the lacing tether remains connected to the distal ring portion of the lacing tether.

[0173] Fig.9A yes Figure 5A Detail of the proximal portion of the device 25 shown. The detail depicts a portion of the housing 40, at least one spool 150, and a removable locking pin 155. The at least one spool 150 is rotatably mounted relative to the housing. The locking pin 155 selectively: (a) prevents the at least one spool 150 from rotating when the pin 155 is installed, or (b) allows the at least one spool 150 to rotate when the pin 155 is removed. The at least one spool is arranged relative to the housing so that at least a portion of the at least one spool is visible from outside the housing.

[0174] In some preferred embodiments, the at least one reel has spokes 152 that improve visibility of the rotation of the at least one reel 150, and the at least one reel 150 is arranged relative to the housing 40 so that at least a portion of the spokes 152 is visible from outside the housing 40. In an alternative embodiment, the at least one reel has a marker (not shown) that improves visibility of the rotation of the at least one reel 150, and the at least one reel 150 is arranged relative to the housing 40 so that at least a portion of the marker is visible from outside the housing 40.

[0175] Fig. 9B A cross-sectional view of a preferred embodiment is depicted, wherein the at least one reel 150 comprises a single reel having: (a) a first region 150a, on which the proximal segment of the first rope extension segment 184 is wound; and (b) a second region 150b, on which the proximal segment of the second rope extension segment is wound. The first region 150a and the second region 150b do not overlap. In an alternative embodiment, two separate reels (not shown) may be used instead of a single reel comprising two regions 150a and 150b.

[0176] The first and second cord extension segments 184 each have a distal end and a proximal segment, and the distal ends of these cord extension segments are connected to the first and second proximal portions 84 of the lacing cord. The proximal segments of the first and second cord extension segments 184 are wound on the at least one reel 150.

[0177] Preferably, the entire lacing rope (including the distal loop portion 82 and the two proximal portions 84 of the lacing rope), the first rope extension segment 184 and the second rope extension segment 184 are continuous segments of a single high tensile strength rope. In some preferred embodiments, the single rope is a Dyneema rope. In some preferred embodiments, the single rope is an ultra-high molecular weight polyethylene rope. In alternative embodiments, the rope extension segments 184 are not adjacent to the lacing rope. Instead, in these embodiments, the distal end of the first rope extension segment 184 is fastened to the first proximal portion 84 of the lacing rope, and the distal end of the second rope extension segment 184 is fastened to the second proximal portion 84 of the lacing rope (e.g., using a suitable adhesive).

[0178] The lacing cord has a distal loop portion 82 ( Figure 8B ) and first and second proximal portions 84 ( Figure 8B The first and second proximal portions 84 of the lacing cord extend distally beyond the distal end of the core 50 and pass through the lumen 52 in the core 50 ( Figure 4A The first and second proximal portions 84 of the lacing cord also extend proximally beyond the proximal end of the core ( Figure 5C The lumen 52 is sized to slidably receive the first and second proximal portions 84 and the first and second cord extension segments 184 of the lacing cord.

[0179] The lacing cords 82, 84, the first and second cord extension segments 184, the inner cavity 52 and the at least one reel 150 are configured such that the lacing cords are connected to the distal loop portion 82 through the at least four anchors 75 ( Figure 8B ) is anchored to the valve annulus or to tissue near the valve annulus and the locking pin 155 has been removed ( Fig.9A ), thereafter, progressive movement of the shell 40 in the proximal direction will: (a) cause the core 50 to progressively move in the proximal direction relative to the first and second proximal portions 84 of the tightening rope, and (b) cause the first and second rope extension segments 184 to progressively unwind from the at least one reel and be progressively pulled into the inner cavity 52, respectively.

[0180] Preferably, the first and second proximal portions 84 of the lacing tethers and the first and second tether extension segments 184 pass through the lumen 52 with very low friction so that when the housing 40 is moved in the proximal direction, the anchors holding the distal ring portion 82 of the lacing tethers to the valve annulus will not be dislodged. Lumens 52 having smooth polymer walls (e.g., polyethylene, polyurethane, polyether block polyamide (pebax), etc.) are suitable for this purpose.

[0181] The housing 40 continues to move in the proximal direction and the cord extension segment 184 continues to unwind from the at least one reel 150 until the entire device 25 (shown in FIG. 1 ) has been removed. At this point, the distal ring portion 82 of the tightening cord remains attached to the valve annulus (eg, Figure 8B ), and the proximal portion 84 of the lacing cord is returned from the valve annulus through the patient's vasculature to an exit point (eg, through the superior vena cava and jugular vein).

[0182] The preferred embodiment relies on tissue ingrowth to strengthen the bond between the distal ring portion 82 of the cinching cord and the valve annulus. Figure 8B In an embodiment of the invention, the distal ring portion 82 of the lacing cord is attached to the valve annulus by anchoring a sleeve 86 (through which the distal ring portion 82 passes) to the valve annulus using an anchor 75. Preferably, the sleeve 86 is made of a material that promotes tissue ingrowth (e.g., a braid). Immediately after implantation, the bond between the distal ring portion 82 and the valve annulus is generally not strong enough to withstand lacing. However, because the sleeve 86 is made of a material that accepts tissue ingrowth, tissue that begins to occur at the valve annulus after implantation will grow into the sleeve 86. This tissue ingrowth eventually (e.g., over the course of 2-12 weeks) strengthens the bond between the sleeve 86 and the valve annulus until the bond is strong enough to withstand lacing.

[0183] It is preferred that the lacing cords 82, 84 have the ability to move freely when the lacing is finally implemented. A preferred method to promote this freedom of movement is to line the sleeve 86 with a material that inhibits tissue ingrowth (e.g., ePTFE, polyurethane, etc.), which will ensure that the distal loop portion 82 of the lacing cord can move freely within the sleeve 86 when the lacing is finally implemented.

[0184] During the period when tissue ingrowth strengthens the bond between the sleeve 86 and the valve annulus (which is desired), tissue ingrowth may also occur between the proximal portions 84 and the vasculature through which they travel. The latter type of ingrowth is undesirable because it may interfere with the ability of the proximal portions 84 to move freely when lacing is ultimately implemented. A preferred method for preventing tissue ingrowth between the proximal portions 84 of the lacing cords and the vasculature through which they travel is to (a) slide a cord protector over the proximal portions of the lacing cords and (b) leave the cord protector in place between when the distal ring portions 82 of the lacing cords are implanted and when lacing ultimately occurs.

[0185] Fig. 10A A suitable rope protector for this purpose is depicted. More particularly, Fig. 10AA cord protector for preventing tissue ingrowth from interfering with the operation of a lacing cord implanted in a subject's body is depicted. The cord protector has a flexible elongated body 120 having a proximal end and a distal end. The elongated body 120 has first and second lumens 122 extending between the proximal and distal ends of the body 120. The lumens 122 are sized to slidably receive a proximal portion of a lacing cord. The body 120 and the lumens 122 are configured to facilitate slidable mounting of the body 120 on the first and second proximal portions of the lacing cord, such that the elongated body 120 covers the first and second proximal portions of the lacing cord, wherein the first and second proximal portions are disposed in the first and second lumens 122, respectively. The body 120 prevents tissue ingrowth into the elongated body itself, and also prevents tissue ingrowth into the first and second proximal portions of the lacing cord when the elongated body 120 covers the first and second proximal portions of the lacing cord.

[0186] In some embodiments, the body 120 is formed of at least one of polyurethane and silicone. In some embodiments, the body 120 is formed of Pellethane 55D polyurethane. In some embodiments, the body 120 has a length between 35 cm and 65 cm and a diameter between 1 mm and 4 mm. In some embodiments, the body 120 has a length between 45 cm and 55 cm and a diameter between 1.5 mm and 2.5 mm. Suitable diameters of the first and second lumens 122 are between 0.2 mm and 1 mm.

[0187] Optionally, the body 120 may have a third lumen 123 that is open at the proximal end, closed at the distal end, and extends through at least three-quarters of the elongated body. The third lumen is sized to slidably receive a reinforcing wire, which may be useful in situations where the body 120 is not rigid enough to be guided to its intended destination by itself. In some embodiments, the diameter of the third lumen 123 is between 0.2 mm and 1 mm.

[0188] Optionally, a radiopaque marker 125 (e.g., 80% platinum and 20% iridium, or other substitutions apparent to those skilled in the relevant art) may be added, preferably disposed near the distal end of the elongated body. Optionally, an ePTFE cover sleeve (not shown) may be added to the cord protector.

[0189] Fig. 10B Depicted is a combination of a set of string 128 Fig. 10AThe first and second threading cords 128 pass through the first and second lumens and extend distally beyond the distal end of the elongated body. The first and second threading cords 128 are configured to pull the first and second proximal portions of the lacing cord into the first and second lumens 122, respectively, so that the first and second proximal portions of the lacing cord can be operated as a guidewire over which the elongated body 120 can be slid to a position where the distal end of the elongated body 120 is adjacent to the distal loop portion of the lacing cord. Suitable materials for the threading cords 128 include nitinol and stainless steel. Optionally, both the rope protector and the threading cord 128 can be packaged in a sterile envelope.

[0190] Fig.11 A method for preventing tissue ingrowth from interfering with tightening a valve annulus using a tightening tether is described. In step S10, the tightening tether is manipulated so that: (a) a distal ring portion of the tightening tether (disposed within a sleeve) is positioned proximal to the valve annulus, and (b) first and second proximal portions of the tightening tether are returned from the distal ring portion of the tightening tether in a proximal direction through the vasculature of the subject (e.g., Figure 7C In step S20, the distal ring portion of the tightening rope is anchored to at least one of the valve annulus and the tissue near the valve annulus. This step is preferably implemented by anchoring the sleeve to at least one of the valve annulus and the tissue near the valve annulus using a plurality of anchors (as shown in FIG. Figure 8B shown).

[0191] In optional step S25, a reinforcing member (e.g., a metal wire) is slid through a third lumen through the elongated cord protector in a proximal-to-distal direction. Then, in step S30, the first and second proximal portions of the lacing cord are covered by a cord protector made of a material that resists tissue ingrowth. The covering step can be performed by sliding an elongated cord protector with two lumens over the first and second proximal portions of the lacing cord so that the proximal portion of the lacing cord passes through the lumens (e.g., Fig. 12A and Fig. 12B as shown) to implement.

[0192] After the anchoring step and the covering step, in step S40, we wait for tissue ingrowth to strengthen the bond between the distal ring portion of the lacing cord and at least one of the annulus and the tissue near the annulus. In some embodiments, the waiting step includes waiting for at least two weeks. However, it is generally preferred to wait for at least two months to ensure that the bond strength is sufficient to withstand the lacing. In many cases, it is recommended to wait for at least three months to ensure that the bond strength is sufficient to withstand the lacing.

[0193] After the waiting step, the rope protector (e.g. Fig.13A shown).

[0194] Then, in step S60, the valve annulus is tightened by pulling the first and second proximal portions of the tightening cord to reduce the diameter of the valve annulus. Tightening can be performed by advancing the push tube 130 in the distal direction over the first and second proximal portions 84 of the tightening cord until the push tube 130 reaches the distal ring portion 82 of the tightening cord, and then pressing the push tube 130 in the distal direction while pulling the first and second proximal portions 84 of the tightening cord in the proximal direction (e.g., Fig. 13B shown).

[0195] After the tightening step, the tightening cord is tightened in step S70 so that the tightening cord holds the valve annulus in a reduced diameter state. This step can be implemented by fastening two parts of the tightening cord together using at least one of a knot, a clip, and a crimp fastener.

[0196] Note that Figures 2 and 6 depict the support arms 72 holding the distal ring portion 82 of the lacing tether in a circular configuration prior to implantation, and Figures 8, 12, and 13 show the distal ring portion 82 in a circular configuration after implantation. In an alternative embodiment (e.g., for installation in a D-shaped human mitral valve annulus), the support arms 72 are shaped to hold the distal ring portion 82 of the lacing tether in a D-shaped configuration prior to implantation, which will form a D-shaped distal ring portion 82 after implantation.

[0197] Fig.14 An alternative embodiment similar to the embodiment of FIGS. 1-8 discussed above is depicted, except that: Fig.14 The embodiment includes a second balloon mounted on the second shaft. More particularly, Fig.14 The embodiment of FIG. 5 adds a second shaft 108 that is slidably disposed within the main channel 55. The second shaft has a second inflation lumen. Fig.14 The embodiment of the present invention further adds an inflatable second balloon 107, which is mounted to the second shaft 108 and connected to the second inflation lumen to allow the second balloon 107 to be inflated via the second inflation lumen. The second balloon 107 is arranged to be distally beyond the first balloon 105. The second shaft 108 is preferably coaxially arranged relative to the first shaft 106 (i.e., the axis of the first balloon 105), wherein the first shaft 106 is arranged and configured so that the two shafts can be independently moved in the proximal to distal direction.

[0198] In some preferred embodiments, the second axis 108 is the innermost axis and the first axis 106 ( Figure 3 ) coaxially around the second axis 108, and the core 50 (also Figure 3 106. Optionally, a lumen (not shown) sized to accommodate a guidewire may be disposed within the second shaft 108. In some preferred embodiments, the lumen is sized to accommodate a 0.035 inch diameter guidewire.

[0199] In some embodiments (including Fig.14 ), the second shaft 108 extends distally beyond the nose cone 100, and the second balloon 107 is positioned distally beyond the nose cone 100. In these embodiments, the nose cone 100 can be mounted to the second shaft 108 (i.e., the same shaft to which the second balloon 107 is mounted), or alternatively, the nose cone 100 can be mounted on its own dedicated third shaft (not shown). In the latter case, the third shaft is preferably slidably disposed within the main channel 55, and the nose cone 100 can be moved between a proximal position and a distal position by slidably adjusting the position of the third shaft. The third shaft is preferably coaxially arranged relative to the first shaft 106 and the second shaft 108, and is configured so that all three shafts can be independently moved in the proximal to distal direction.

[0200] In alternative embodiments (not shown), the nose cone 100 is positioned distally beyond the second balloon 107. In these embodiments, the nose cone 100 can be mounted to a portion of the second shaft 108 that extends distally beyond the second balloon 107.

[0201] It is preferred that the anchor be fired when the distal end of the anchor launcher is pressed against the annulus or against tissue near the annulus, and the second balloon 107 may be used in different ways to help press the anchor launcher against the annulus or tissue depending on the anatomical environment in which the tether is installed.

[0202] In one example, when the lacing cord is installed at the tricuspid valve annulus, the distal assembly 70 ( Figure 6B ) is positioned in the right atrium, and a second balloon 107 ( Fig.14 The distal assembly 70 is shown in the figure) in a collapsed state and advanced through the bifurcation into the pulmonary artery (i.e., into the right pulmonary artery or into the left pulmonary artery). The second balloon 107 has been inflated. When the second balloon 107 is inflated at this location, it will act as a temporary anchor to help manipulate the distal assembly 70 toward the annular plane and gently press the valve ring against the annulus during anchor deployment.

[0203] In another example, when the lacing tether is installed at the mitral valve annulus, when the second balloon 107 is positioned near the middle of the subject's ventricle (e.g., the left ventricle 33) and inflated, the movement of the heart wall and / or the movement of blood traveling through the heart during a selected portion of the cardiac cycle (e.g., one of systole, diastole, etc.) will apply a force that pushes the second balloon 107 toward the apex of the heart. This phenomenon can be used to press the distal end of the anchor transmitter 74 against the valve annulus. The second balloon 107 and the assembly including the anchor transmitter 74 are formed by the same support member (e.g., Figure 3The triggering of the anchor transmitter 74 can then be timed to coincide with compression occurring during a selected portion of the cardiac cycle.

[0204] Fig.15 Is used for Fig.14 A flow chart of a method for implementing a double balloon embodiment of a method for implanting a valve ring or a tightening rope into a heart valve annulus (or into tissue near the valve annulus). The valve annulus is disposed between the atrium and the ventricle of the heart. The method includes step S100, in which an assembly is delivered into the atrium. The assembly includes (a) a valve ring or a tightening rope, (b) a plurality of anchors connected to the valve ring or the tightening rope, and (c) a plurality of anchor launchers configured to launch anchors into the valve annulus or into tissue near the valve annulus. The assembly is composed of a support member (e.g., a core 50, such as Figure 3 shown) support.

[0205] Next, in step S110, the assembly is positioned so that the valve ring or tightening tether is adjacent to the valve annulus or adjacent to tissue near the valve annulus on the atrial side of the valve annulus. In step S120, the inflatable balloon is advanced into the ventricle. The balloon is supported by the support member that supports the assembly. In step S130, the balloon is inflated while the balloon is in the ventricle. In step S140, the position of the balloon in the ventricle is adjusted so that when a selected portion of the cardiac cycle occurs when the balloon is inflated, the force acting on the balloon will push the balloon toward the apex of the heart, which will push the support member toward the apex of the heart, which will push the valve ring or tightening tether toward the valve annulus or toward tissue near the valve annulus. Next, in step S150, the time when the selected portion of the cardiac cycle occurs is determined when the inflated balloon is in the adjusted position.

[0206] In step S160, the anchor launcher is triggered (e.g., by actuating the trigger 47 after removing the locking pin 48, both in Figure 5C ), such that the anchor transmitter launches the anchor into the valve annulus or into tissue near the valve annulus during a selected portion of the cardiac cycle when the inflated balloon is in the adjusted position.

[0207] In some embodiments, the determining in step S150 includes detecting when the support member is pulled in the distal direction. In some embodiments, the advancing in step S120 includes sliding the shaft in the distal direction relative to the support member to which the inflatable balloon is mounted. In some embodiments, the positioning in step S110 includes inflating the first balloon 105 between the plurality of support arms 72 supporting the anchor transmitter 74, such that the additional balloon 105 pushes the support arms 72 away from each other (as described above). Figure 7C shown).

[0208] In some embodiments, the delivery in step S100 includes: introducing the valve ring or tightening rope, anchor and anchor transmitter into the atrium while the tightening rope, anchor and anchor transmitter are retracted within an outer sleeve; and withdrawing the outer sleeve so that the tightening rope, anchor and anchor transmitter extend beyond the distal end of the outer sleeve.

[0209] Fig.16 Depicted Fig. 6A A variation of the embodiment of the invention in which the lacing cord has been replaced with a valve ring. In this embodiment, instead of implanting the distal ring portion 82 of the lacing cord into the valve ring, the proximal portion 84 of the lacing cord extends back through the core 50 (as described above in conjunction with the Fig. 6A The valve ring 182 is implanted in the valve ring or in the tissue near the valve ring. Preferably, the valve ring 182 is surrounded by a sleeve 186 in a manner similar to that in which the distal ring portion 82 of the tightening rope is encapsulated in the valve ring. Fig. 6A Similarly, the tightening ropes in any other embodiments discussed above can be replaced with valve rings.

[0210] When the above is combined with Figures 1-9 and Fig.14 As the device 25 is withdrawn from the patient's body, there is a possibility that components moving in the proximal direction (e.g., anchor launcher 74, support arm 72, balloon 105, outer sleeve 60, etc.) will catch the proximal portion 84 of the lacing cord. (See, e.g., Fig. 8A and 8B If this occurs, the forces acting on the proximal portion 84 of the lacing tether will pull on the distal ring portion 82 of the lacing tether, and these forces may be sufficient to dislodge one or more of the anchors 75 from the valve annulus 35.

[0211] Fig.17 and 18 An alternative method of preventing dislocation of the anchor 75 in these circumstances is depicted. This embodiment is similar to the embodiment of Figures 1-9 described above, but with the addition of additional components 210-222 to reduce the risk of dislocation. Fig.17 Depicted is a distal portion of the device just prior to launching an anchor 75 from an anchor launcher 74; Fig.18 The device is depicted after the anchor 75 has been implanted in the annulus 35 and retrieval of the device has begun.

[0212] As can be clearly seen in Figures 1, 3 and 4A, the device includes a housing 40 and an elongated core 50 mounted relative to the housing 40. The core has: at least one second channel 52, which passes through the core in a proximal to distal direction; and at least one fourth channel (not shown) which passes through the core in a proximal to distal direction. These fourth channels are similar to those described above in conjunction with Figure 4A The second channel 52. In some preferred embodiments, there are two second channels and two fourth channels.

[0213] The lacing cord has a distal loop portion and first and second proximal portions 84. The proximal portion of the lacing cord is slidably disposed within the at least one second channel and extends distally beyond the distal end of the core. In some preferred embodiments, each proximal portion of the lacing cord is disposed within its own independent lumen.

[0214] Now go to Fig.17 At least four support arms 72 are mounted to the core and extend distally beyond the distal end of the core. At least four anchors 75 ( Fig.18 ) is configured to anchor the distal ring portion of the tightening cord into the valve annulus or into tissue adjacent to the valve annulus. (Note that Fig.17 , the distal ring portion of the tightening tether is covered by a sleeve 86 made of a material that promotes tissue ingrowth.) At least four anchor launchers 74 are supported by a corresponding one of the support arms 72, and each anchor launcher is configured to launch a corresponding one of the anchors into the valve annulus or into tissue near the valve annulus.

[0215] At least one wire 215 is slidably disposed within the at least one fourth channel. Each of these wires has a distal end that extends distally beyond the distal end of the core and has a proximal end that extends proximally beyond the fourth channel. In some preferred embodiments, the at least one wire comprises two wires and the at least one fourth channel comprises two channels, wherein each of the two wires is slidably disposed within a respective one of the two channels. In some preferred embodiments, each of these wires 215 is a nitinol wire having a diameter between 0.3 mm and 0.5 mm (e.g., 0.4 mm).

[0216] The pushing member 210 is fixed to the distal end of the at least one wire 215, so that by pushing the proximal end of the at least one wire 215 in the distal direction, the pushing member 210 will be pushed in the distal direction. Fig.17In some embodiments, the pushing member 210 is a hollow cylinder arranged so that the axial axis of the hollow cylinder is parallel to the at least one wire 215, and the first and second proximal portions 84 of the lacing cord pass through the interior of the hollow cylinder and are slidably disposed in the hollow cylinder. In some embodiments, the pushing member 210 is a hollow cylinder laser cut from a nitinol tube and has an outer diameter between 1.25 mm and 2 mm (e.g., 1.63 mm). In some embodiments, the hollow cylinder has a relatively large wall thickness (e.g., 0.23 mm), and the edges of the hollow cylinder are rounded (e.g., by electropolishing) to reduce the risk of damaging the proximal portions 84 of the lacing cord when they slide through the hollow cylinder.

[0217] It is preferred to use multiple wires 215 terminating on the pushing member 210 (compared to a single wire 215) to improve pushability and stability.

[0218] Fig.17 The embodiment of / 18 also includes an optional anti-extrusion channel 220, which is arranged to extend distally beyond the distal end of the core. Preferably, the inner wall of the anti-extrusion channel 220 is made of a low-friction material. The first and second proximal portions 84 of the tightening rope are slidably disposed in the anti-extrusion channel. Preferably, the space between the distal end of the core and the proximal end of the anti-extrusion channel is kept as small as possible. In some embodiments, the anti-extrusion channel 220 is configured so that before the anchor is fired, the anti-extrusion channel 220 extends all the way to the pushing member 210, such as Fig.17 One suitable method for implementing such an anti-crush channel 220 is to use a Pebax tube reinforced with a polyester braid having an inner diameter of approximately 1 mm. When these components 72, 74 are retracted, the anti-crush channel 220 prevents the support arm 72 and the anchor launcher 74 from grabbing the proximal portion 84 of the lacing cord (which passes through the anti-crush channel 220).

[0219] In some embodiments, the anti-extrusion channel 220 is supported by at least one support arm fixed to the core. These support arms can have a similar structure to the support arms 72 holding the anchor launchers 74, and can be connected to the core in the same manner as those support arms 72, as described above. The anti-extrusion channel 220 can be attached to its support arms using, for example, heat shrink tubing and / or adhesives.

[0220] After the anchor launcher has been manipulated to the desired position adjacent to the valve annulus 35, the anchor launcher is combined with the above Figures 7A-7D The same method as described above is followed.

[0221] Now go to Fig.18 After the anchor has been fired, the distal loop portion of the lacing rope (which is Fig.18 The core is then pulled back through the outer sleeve 60, which causes the support arms 72 and the anti-extrusion channel 220 to move in the proximal direction. As the core is pulled back, the operator pushes the wire 215 in the distal direction, which pushes the push member 210 against the tissue of the valve annulus 35, such as Fig.18 Because the proximal portion 84 of the lacing cord is threaded through the passage (e.g., the interior of the hollow cylinder) of the pushing member 210 extending in the proximal-to-distal direction, the distal end of the pushing member will hold the proximal portion 84 of the lacing cord against the tissue. This will hinder the anchor 75 from being displaced during the movement of the housing in the proximal direction by eliminating (or at least reducing) forces that may tend to pull the anchor 75 out of the tissue.

[0222] Progressive movement of housing 40 (shown in FIG. 1 ) in the proximal direction will cause core 50 (also shown in FIG. 1 ) to progressively move in the proximal direction relative to first and second proximal portions 84 of the lacing cord. Fig.18 The point in time depicted in FIG. 1 is when the core has been retracted several centimeters, causing the support arms 72 and anchor launchers 74 to begin to retract and be pulled back into the outer sheath 60. Because the proximal portion 84 of the lacing cord passes through the anti-crush channel 220, the channel will protect the proximal portion 84 of the lacing cord from being caught by the support arms 72 and anchor launchers 74 as these components move in the proximal direction.

[0223] The operator then continues to retract the entire device while continuing to compress the wires 215 in the distal direction. Once the entire device 25 has been removed, the operator can release the distal pressure on the wires 215 and pull the wires out of the patient's body in the proximal direction. The wires 215 pull the push member 210 out of the patient's body. As this occurs, the proximal portion 84 of the lacing cord will slide through the passage in the interior of the push member 210 until the push member 210 is fully retracted.

[0224] Fig.19 Another embodiment similar to that described above in conjunction with FIG. 4 is depicted, however, (a) Fig.14 The nose cone is deleted in the embodiment; and (b) the two-piece sleeve is replaced Fig.14 The outer sleeve 60 of the embodiment of the two-piece sleeve includes a first sleeve 62 and a second sleeve 65. Note that this two-piece sleeve construction can be used to replace the single outer sleeve 60 in any embodiment described herein.

[0225] Fig.19 The first sleeve 62 in the embodiment of Fig.14 The outer sleeve 60 in the embodiment of the present invention is different in that the first sleeve 62 is larger than Fig.14 More specifically, the length of the first sleeve 62 is such that the anchor launcher is not covered by the first sleeve 62 even when the first sleeve 62 is in its maximum extended position.

[0226] A second sleeve 65 is disposed at the distal end of the device and covers the distal end of the first sleeve 62 and extends distally beyond the distal end of the first sleeve 62 to cover the anchor launcher. The inner diameter of the second sleeve 65 is slightly larger than the outer diameter of the first sleeve 62 to allow the first sleeve 62 to slide within the second sleeve 65. The second sleeve 65 is preferably configured so that it can be torn open (e.g., by pulling the tab 66) and removed. An example of a commercially available component suitable for use as the second sleeve 65 is from Cook Medical 22 French outer sleeve component of the introducer kit (reference numbers C-PLI-22.0-38 and G04518).

[0227] When compared with This embodiment is particularly useful for accessing the tricuspid annulus when used in conjunction with an introducer sheath of the DrySeal sheath, which should have the same outer diameter as the second sleeve 65 (e.g., 22 French). To access the tricuspid annulus using this embodiment, The distal end of the DrySeal sheath is introduced via the jugular vein and advanced until it enters the right atrium. A guidewire is then passed through the DrySeal sheath, across the valve annulus into the right ventricle, and into the pulmonary artery until it passes the bifurcation in the pulmonary artery in either direction, into the right or left pulmonary artery.

[0228] Distal balloon 107 ( Fig.14 65) is advanced over the guidewire into the DrySeal sheath. Then, the entire device (including but not limited to the second sleeve 65) is advanced in the distal direction until the distal end of the second sleeve 65 reaches the proximal entrance of the DrySeal sheath. Because the outer diameter of the second sleeve 65 is the same as the outer diameter of the DrySeal sheath, the second sleeve 65 will not be able to move into the DrySeal sheath. The distal balloon 107 is threaded on the guidewire. Next, the entire device except the second sleeve 65 (blocked by the DrySeal sheath) is advanced in the distal direction, so that the first sleeve 62 slides in the distal direction inside the second sleeve 65. The distal assembly 70 will slide through the second sleeve 65 and slide into the DrySeal sheath, after which the distal end of the first sleeve 62 will slide into the DrySeal sheath. At this time, the operator pulls the tab 66 of the second sleeve 65 and removes the sleeve. Subsequently, the entire device continues to advance until the distal assembly 70 leaves the distal end of the DrySeal sheath. At this point, the DrySeal sheath may be retracted several centimeters to improve maneuverability of the distal assembly 70 within the right atrium.

[0229] The distal assembly 70 is then advanced relative to the first sleeve 62 and the DrySeal sheath until the support arm 72 can be sprung open due to spring action or shape memory effect. The distal balloon is then moved beyond the bifurcation in either direction into the pulmonary artery and inflated. The orientation of the distal assembly 70 is adjusted, for example, using the controller 42 or by moving the entire housing 40 so as to approach the valve annulus. Fluorine guidance can be used for this purpose, optionally relying on the radiopaque sleeve 98. The proximal balloon 105 is inflated to help expand the support arm 72 and allow the distal assembly to move as a single unit. Optionally, the shaft 106 of the proximal balloon 105 can be locked at this time. Additional adjustments are made to the orientation of the distal assembly, and the anchor is fired by actuating the trigger 47 of the spring-loaded actuator 46.

[0230] Pressure is applied to the push member 210 by pushing the wire 215 distally, collapsing the balloon and advancing the DrySeal sheath in the distal direction until the support arm 72 begins to contract. The entire device is then retracted by moving the housing 40 in the proximal direction. The distal pressure acting on the push member 210 will squeeze the proximal portion 84 of the lacing cord against the tissue, which will prevent displacement of the anchor, as described above. Continued retraction of the housing 40 will pull the support arm and anchor transmitter 74 through the DrySeal sheath in the proximal direction (while continuing to push on the push member 210) until only the lacing cords 82, 84, the surrounding sleeve 86, the anchor 75, the push member 210, and the push wire 215 remain. Finally, the push member 210, the push wire 215, and the DrySeal sheath are retracted.

[0231] Although the present invention has been disclosed with reference to certain embodiments, several modifications, variations and changes may be made to the described embodiments without departing from the scope and range of the invention as defined in the appended claims. Therefore, it is intended that the present invention is not limited to the described embodiments, but has the full scope defined by the language of the appended claims and their equivalents.

Claims

1. A device for delivering a tightening cord near a valve annulus, the device comprising: an elongated core having: (a) a distal end; (b) a main passage through the core in a proximal to distal direction; (c) at least four first passages extending through the core in a proximal to distal direction, each first passage being sized to receive a corresponding pull wire; and (d) at least one second passageway extending through the core in a proximal-to-distal direction, the second passageway being sized to receive a first proximal portion and a second proximal portion of a lacing cord; at least four support arms mounted to the core, the support arms extending distally beyond a distal end of the core; and at least four anchor transmitters, each anchor transmitter having a distal end, wherein each anchor transmitter is supported by a respective one of the at least four support arms, Wherein, the support arm is configured to maintain the distal end of the anchor transmitter at a position corresponding to the shape of the valve annulus, wherein the distal end of the anchor transmitter is distributed around the periphery of the shape of the valve annulus.

2. The device according to claim 1, further comprising: at least four anchors, each anchor disposed in a respective one of the at least four anchor transmitters; a lacing cord having a distal loop portion, a first proximal portion, and a second proximal portion, wherein the first proximal portion and the second proximal portion are disposed in the at least one second channel, and the anchor is connected to the distal loop portion of the lacing cord; and At least four pull wires are each disposed in a respective one of the at least four first channels, wherein each pull wire is operatively connected to a respective one of the at least four anchor launchers such that pulling the respective pull wire will launch the respective anchor.

3. The device according to claim 1, further comprising: a plurality of support rings, wherein the support arms are secured to the support rings and extend in a distal direction from the support rings; and a plurality of support rods fixed to the support ring, wherein the support rods extend from the support ring in a proximal direction, wherein the core has a plurality of third channels, the third channels passing through the core in a proximal to distal direction, and the dimensions of the third channels are designed to accommodate the support rods, and wherein the support arm is mounted to the core by inserting the support rod into the third channel.

4. The device of claim 3, further comprising a radiopaque material distributed on the support rods in an asymmetric pattern.

5. The device according to claim 1, wherein: The main channel is centered on the radial center of the core.

6. The device according to claim 1, wherein: Each of the first channels and each of the at least one second channel are located at the same radial distance from a radial center of the core.

7. The device according to claim 1, wherein: Each of the first channels includes an inner lumen, and each of the at least one second channel includes an inner lumen.

8. The device according to claim 1, wherein: Each of the first channels and each of the at least one second channel are located at the same radial distance from a radial center of the core, wherein each of the first channels includes an inner cavity and each of the at least one second channel includes an inner cavity.

9. The device according to claim 1, wherein: The at least four support arms include at least eight support arms, wherein the at least four first channels include at least eight first channels, and the at least four anchor launchers include at least eight anchor launchers.

10. The device according to claim 1, wherein: The valve annulus is a mitral valve annulus.

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