Tissue Contraction Implants for Heart Valves

Abstract

A system for use in a valve between the atrium and the ventricle of the heart includes a catheter (170), a first subassembly (112a), a second subassembly (112b), and a tool (180). The catheter is transluminally advanceable to the heart. Each of the subassemblies includes (i) a tether (130a, 130b) having two end portions (132a, 132b, 134a, 134b) and a curved portion (136a, 136b) therebetween, advanceable from the catheter distally into the heart starting at the curved portion, and (ii) a set (118a, 118b) of anchors (120) configured to secure the curved portions to tissue of the heart such that the anchors are slidably coupled to the curved portions in series. The tool is slidable over both end portions of both tethers toward both curved portions and configured to selectively apply tension to each tether by selectively pulling on each of the end portions. Other embodiments are also described.

Description

[Technical field]

[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This application claims priority to U.S. Provisional Patent Application No. 63 / 166,170, entitled “Tissue-contracting implants” (Guerrero et al.), filed March 25, 2021, which is incorporated herein by reference. [Background technology]

[0002] Annuloplasty involves remodeling tissue at the annulus of a heart valve. This can be done by pulling the tissue around the annulus into a new shape. Tissue anchors can be used to facilitate medical procedures including annuloplasty, other remodeling of tissue, and securing implants. In some cases, tissue anchors can be used as an alternative to sutures. For example, tissue anchors may be used to implant annuloplasty rings or bands that extend around at least a portion of the annulus. [Prior art documents] [Patent documents]

[0003] [Patent Document 1] U.S. Patent Application Serial No. 17 / 145,258 [Patent Document 2] U.S. Patent Application No. 63 / 162,443 [Patent Document 3] US Patent Application Publication No. 2018 / 0049875 [Patent Document 4] International Publication No. WO / 2020 / 240282 [Patent Document 5] US Patent Application Publication No. 2020 / 0015971 [Patent Document 6] US Patent Application Publication No. 2012 / 0078355 [Patent Document 7] US Patent Application Publication No. 2015 / 0272734 Summary of the Invention

[0004] Some of the concepts and applications disclosed herein relate to an implant for use in an atrioventricular valve (e.g., mitral or tricuspid valve) of a subject. Such an implant may include at least two anchoring assemblies connected to each other by a bridge having an adjustable bridge length. Each such anchoring assembly may include multiple anchors connected by connectors and is configured to be anchored by the anchors to respective portions of tissue around the valve (e.g., respective portions of the annulus, such as respective sides of the annulus) such that subsequent adjustment (e.g., reduction) of the bridge length reshapes the valve (e.g., shrinks the annulus).

[0005] In some applications, the bridges and connectors include (e.g., are defined by) various portions of the tether that are slidably coupled to the anchors. In such applications, the bridge length can be adjusted by adjusting the tension on the tether.

[0006] In some applications, the implant includes an adjustment mechanism operably coupled to one or more of the bridges, in which the bridge length may be adjusted by actuating the adjustment mechanism.

[0007] The implant may be advanced to the heart transluminally and / or transcatheterically. In some applications, the implant is advanced to the heart in a preassembled state. In some applications, the implant is assembled within the heart.

[0008] A driver is often used to secure the anchors to the tissue. When the implant is implanted, each of the bridges often extends at least part way across the valve (e.g., into the atrium, across the valve orifice and / or leaflets).

[0009] Adjustment of the bridge length may be performed using a tool that is advanced into the implant within the heart.

[0010] According to some applications, a system is provided for use with a valve disposed between an atrium and a ventricle of a subject's heart. The system includes an implant, a driver, a tool, and often also a catheter advanceable transluminally into the heart. For some applications, the implant includes (a) a first anchoring assembly and a second anchoring assembly, each including a plurality of anchors and a connector connecting the plurality of anchors to one another, and (b) one or more bridges connecting the first anchoring assembly to the second anchoring assembly and having an adjustable bridge length.

[0011] In some applications, the driver may be extendable through the catheter and is often further configured to secure a first anchoring assembly into the atrium at a first portion (e.g., a first side) of the valve using anchors of the first anchoring assembly and secure a second anchoring assembly into the atrium on a second side of the valve using anchors of the second anchoring assembly such that each of the bridges extends at least part way across. The tool is configured to adjust the distance between the first anchoring assembly and the second anchoring assembly by adjusting a bridge length of at least one of the bridges.

[0012] According to some applications, a method is provided for use with a valve, where a first series of anchors of a first anchoring assembly are anchored in the atrium in a first row (e.g., generally linear or arcuate) along a first portion of the annulus such that a first connector of the first anchoring assembly connects the first series to one another and extends along a first portion of the annulus, and a second series of anchors of a second anchoring assembly are anchored in the atrium in a second row along a second portion of the annulus such that a second connector of the second anchoring assembly connects the second series to one another and extends along a second portion of the annulus.

[0013] Typically, the tool is then advanced transluminally into the heart. The distal end of the tool may be positioned within the atrium, for example, over the orifice and / or leaflets of the valve. The tool may be used to reshape the valve annulus, for example, by reducing a bridge length of a bridge connecting a first anchoring assembly to a second anchoring assembly.

[0014] The above methods can be performed in live animals or in simulations, such as cadavers, cadaver hearts, simulators (eg, simulated body parts, cardiac tissue), and the like.

[0015] According to some applications, a system and / or device is provided for use with a valve disposed between an atrium and a ventricle of a subject's heart, the system and / or device including a catheter, a first subassembly, a second subassembly, and a tool. The catheter is transluminally advanceable to the heart. The first subassembly may include (i) a first tether having a first end portion, a second end portion, and a first curve therebetween, the first tether being advanceable starting at the curve and distally out of the catheter into the heart, and (ii) a first set of anchors configured to anchor the first curve to tissue of the heart such that the first set of anchors are slidably coupled to the first curve in a first series.

[0016] For some applications, the second subassembly may include (i) a second tether having a third end portion, a fourth end portion, and a second curved portion therebetween, the second tether being advanceable starting at the curved portion and distally out of the catheter and into the heart, and (ii) a second set of anchors configured to secure the second curved portion to tissue of the heart such that the second set of anchors are slidably coupled to the second curved portion in a second series.

[0017] For some applications, the tool is slidable around the first, second, third, and fourth end portions toward the first and second curved portions. The tool can be configured to selectively apply tension to the first and second tethers by selectively pulling each of the first, second, third, and fourth end portions.

[0018] For some applications, the system and / or device further includes a driver configured to secure each anchor of the first set to cardiac tissue.

[0019] For some applications, the driver is configured to be advanced transluminally into the heart while coupled to a first anchor of the first set to secure the first anchor to tissue.

[0020] For some applications, the driver is configured to be advanced transluminally into the heart while the first anchor of the first set is slidably coupled to the first curved portion.

[0021] For some applications, the driver is configured to transluminally advance the first curved portion through the catheter and into the heart by transluminally advancing a first anchor of the first set through the catheter while the first anchor of the first set is slidably coupled to the first curved portion.

[0022] For some applications, the driver is configured to slide a second anchor of the first set onto the first curved portion over and along the first end portion and then anchor the second anchor to the tissue, thereby positioning at least a portion of the first curved portion along the tissue between the first anchor and the second anchor of the first set.

[0023] For some applications, the driver is configured to anchor each anchor of the first set in a first row along the heart tissue, thereby positioning at least a portion of the first curve along the tissue, and to position each anchor of the second set in a second row along the heart tissue, the second row extending from the first row across the valve, thereby positioning at least a portion of the second curve from the first curve across the valve.

[0024] In some applications, when a first set of anchors is anchored in the first row and a second set of anchors is anchored in the second row, the tool is configured such that sliding of the tool over the first end portion, the second end portion, the third end portion, and the fourth end portion retracts the first end portion, the second end portion, the third end portion, and the fourth end portion halfway between the first and second rows, converging at the bridge node.

[0025] For some applications, the tool is configured to lock tension in the first and second tethers by advancing a lock over the first end portion, the second end portion, the third end portion, and the fourth end portion toward the first and second curved portions to lock the lock into the first end portion, the second end portion, the third end portion, and the fourth end portion.

[0026] In some applications, the valve has an annulus defining a valve orifice, and the tool is configured to engage the lock to the first end portion, the second end portion, the third end portion, and the fourth end portion such that the lock is positioned over the valve orifice.

[0027] For some applications, the tool has an extracorporeal proximal portion that includes a user interface including a first tether controller configured to pull the first end portion, a second tether controller configured to pull the second end portion, a third tether controller configured to pull the third end portion, and a fourth tether controller configured to pull the fourth end portion.

[0028] In some applications, the tool includes at least one engagement controller configured to engage the first tether controller with the first end portion, the second tether controller with the second end portion, the third tether controller with the third end portion, and the fourth tether controller with the fourth end portion following advancement of the tool over the first end portion, the second end portion, the third end portion, and the fourth end portion.

[0029] For some applications, a method for use with a valve disposed between an atrium and a ventricle of a subject's heart, the valve defining an orifice and having an annulus surrounding the orifice, the method including: (i) within the atrium, a first end portion and a second end portion of a first tether are disposed outside the heart, and a curved portion of a first tether is positioned along a first portion of the annulus by securing a first series of anchors, the first curved portion slidably coupled to the first curved portion, to a first portion of the annulus, such that the first curved portion and the first series define a first anchor securing assembly; and (ii) within the atrium, a third end portion and a fourth end portion of a second tether are disposed outside the heart, and a curved portion of a second tether is positioned along a second portion of the annulus by securing a second series of anchors, the second curved portion slidably coupled to the second curved portion, to a second portion of the annulus, such that the second curved portion and the second series define a second anchor securing assembly.

[0030] The method may further include defining (i) a bridge node at a distal end of the tool, (ii) a portion of the first tether as a first bridge portion extending between the first anchoring assembly and the bridge node, (iii) another portion of the first tether as a second bridge portion extending between the first anchoring assembly and the bridge node, (iv) a portion of the second tether as a third bridge portion extending between the second anchoring assembly and the bridge node, and (v) another portion of the second tether as a fourth bridge portion extending between the second anchoring assembly and the bridge node, and transluminally advancing the tool over and along the first end portion, the second end portion, the third end portion, and the fourth end portion and thereafter into the atrium in a manner such that the first bridge portion, the second bridge portion, the third bridge portion, and the fourth bridge portion converge at the bridge node.

[0031] The method may then include reshaping the annulus by applying tension to the first and second tethers by retracting at least a portion of the first anchoring assembly proximate the second anchoring assembly. The tension may then be locked to the first and second tethers by locking the first and second tethers at the bridge node.

[0032] In some applications, the first series of anchors are first series of anchors threaded onto the first curve, and securing the first series of anchors to the first portion of the annulus includes securing the first series of anchors threaded onto the first curve to the first portion of the annulus.

[0033] For some applications, tensioning the first tether and the second tether includes tensioning the first tether independently of tensioning the second tether.

[0034] In some applications, applying tension to the first tether and the second tether includes pulling the first end portion and pulling the third end portion independently of pulling the first end portion.

[0035] In some applications, applying tension to the first tether and the second tether includes pulling the first end portion and pulling the second end portion independently of pulling the first end portion.

[0036] For some applications, securing the first series of anchors and the second series of anchors includes securing the first series of anchors and the second series of anchors such that, for each of the first series and the second series, (i) one of the anchors in the series is a first terminal anchor of the series and is disposed at a first end of the series, and (ii) another of the anchors in the series is a second terminal anchor of the series and is disposed at a second opposing end of the series.

[0037] In some applications, advancing the tool transluminally includes advancing the tool transluminally such that a first bridge portion extends between the first series and a first terminal anchor of the bridge node, a second bridge portion extends between the bridge node and a second terminal anchor of the first series, a third bridge portion extends between the bridge node and a first terminal anchor of the second series, and a fourth bridge portion extends between the bridge node and a second terminal anchor of the second series.

[0038] In some applications, the first portion of the annulus underlies a first leaflet of the valve and the second portion of the annulus underlies a second leaflet of the valve, and reshaping the annulus includes retracting the first leaflet and the second leaflet toward each other.

[0039] In some applications, the valve is a mitral valve of the heart, and remodeling the valve annulus includes remodeling the mitral valve annulus.

[0040] In some applications, the valve is a tricuspid valve of the heart, and reshaping the valve annulus includes reshaping the tricuspid valve annulus.

[0041] In some applications, placing the first tether curved portion along the first portion of the annulus includes transluminally advancing a first anchor of the first series into the atrium while the first anchor of the first series is slidably coupled to the first curved portion, by transluminally advancing the first anchor of the first series into the atrium, then anchoring the first anchor of the first series, then transluminally advancing a second anchor of the first series over and along the first end portion into the atrium toward the first anchor of the first series, and then anchoring the second anchor of the first series to the first portion of the annulus.

[0042] In some applications, positioning the curved portion of the first tether along the first portion of the annulus includes, following fixation of the first series of second anchors, transluminally advancing a third anchor of the first series over and along the first end portion into the atrium toward the second anchor of the first series, and then fixating the third anchor of the first series to the first portion of the annulus.

[0043] In some applications, positioning the curved portion of the first tether along the first portion of the annulus includes, following fixation of the first series of second anchors, transluminally advancing a third anchor of the first series over and along the second end portion into the atrium toward the second anchor of the first series, and then fixating the third anchor of the first series to the first portion of the annulus.

[0044] For some applications, the method further includes withdrawing the anchor driver from the subject after securing the first anchor of the first series and before advancing the second anchor of the first series.

[0045] In some applications, transluminally advancing the first curved portion into the atrium includes transluminally advancing the first curved portion into the atrium using an anchor driver that engages with a first anchor of the first series.

[0046] For some applications, transluminally advancing the second anchor of the first series includes transluminally advancing the second anchor of the first series using an anchor driver.

[0047] In some applications, locking the lock to the first tether and the second tether at the bridge node includes locking the lock to the first bridge portion, the second bridge portion, the third bridge portion, and the fourth bridge portion at the bridge node.

[0048] In some applications, locking the lock to the first bridge portion, the second bridge portion, the third bridge portion, and the fourth bridge portion includes (i) locking a first locking element of the lock to the first bridge portion; and (ii) locking a second locking element of the lock to the second bridge portion separately from locking the first locking element to the first bridge portion.

[0049] In some applications, the method further includes, following advancing the tool in a manner to define bridge nodes and bridge portions, repositioning a distal end of the tool in a manner to reposition the bridge nodes, lengthen at least one of the bridge portions, and shorten at least one of the bridge portions prior to locking tension on the first tether and the second tether.

[0050] In some applications, repositioning the distal end of the tool includes repositioning the distal end of the tool to reposition the bridge node away from the first anchoring assembly and toward the second anchoring assembly.

[0051] In some applications, advancing the tool into the atrium in a manner to define a bridge node includes advancing the tool in a manner to define a bridge node in the atrium.

[0052] In some applications, advancing the tool in a manner to define a bridge node within the atrium includes advancing the tool in a manner to define a bridge node over an orifice of the valve.

[0053] The above methods can be performed in live animals or in simulations, such as cadavers, cadaver hearts, simulators (eg, simulated body parts, cardiac tissue), and the like.

[0054] According to some applications, a system and / or device is provided for use with a valve positioned between an atrium and a ventricle of a subject's heart, the system and / or device including a catheter advanceable transluminally into the heart and an implant deployable from the catheter within the heart.

[0055] For some applications, the implant includes a first anchoring assembly and a second anchoring assembly, each of which includes a plurality of anchors and a connector connecting the plurality of anchors to one another.

[0056] For some applications, the implant further includes one or more bridges connecting the first anchoring assembly to the second anchoring assembly and having an adjustable bridge length.

[0057] For some applications, the system and / or device includes a driver extendable through the catheter and configured to use an anchor of the first anchoring assembly to secure the first anchoring assembly in the atrium to a first side of the valve and an anchor of the second anchoring assembly to secure the second anchoring assembly in the atrium to a second side of the valve such that each of the bridges extends at least part way across the valve.

[0058] In some applications, the system and / or device includes a tool advanceable transluminally into the heart and configured to adjust the distance between the first anchoring assembly and the second anchoring assembly by adjusting a bridge length of at least one of the bridges.

[0059] For some applications, the tool is transluminally advanceable to the implant and configured to engage the implant within the atrium.

[0060] In some applications, the valve has an annulus and leaflets, the annulus surrounding an orifice within which the leaflets are disposed, and the tool is configured to engage an implant over the orifice and within the atrium.

[0061] For some applications, the tool is configured to exclusively engage the implant between the first anchoring assembly and the second anchoring assembly.

[0062] In some applications, each connector of the anchoring assembly is rigid.

[0063] In some applications, the connectors of each of the anchoring assemblies are flexible.

[0064] In some applications, each connector of the anchoring assembly is axially contractible.

[0065] In some applications, each connector of the anchoring assembly is resistant to axial shrinkage.

[0066] For some applications, each of the bridges is articulably connected to one of the first anchoring assembly and the second anchoring assembly.

[0067] For some applications, the one or more bridges include a first bridge extending from a first portion of the first anchoring assembly, a second bridge extending from a second portion of the first anchoring assembly, a third bridge extending from the first portion of the second anchoring assembly, and a fourth bridge extending from the second portion of the second anchoring assembly.

[0068] In some applications, the first bridge, the second bridge, the third bridge, and the fourth bridge converge at a bridge node partway between the first anchoring assembly and the second anchoring assembly.

[0069] For some applications, the implant includes a first tether that loops from the bridge node to a first portion of the first anchoring assembly, thereby defining a first bridge, loops from the first portion of the first anchoring assembly to a second portion of the first anchoring assembly, thereby defining a connector of the first anchoring assembly, and loops from the second portion of the first anchoring assembly back to the bridge node, thereby defining a second bridge.

[0070] For some applications, the implant includes a second tether that loops from the bridge node to a first portion of the second anchoring assembly, thereby defining a third bridge, loops from the first portion of the second anchoring assembly to a second portion of the second anchoring assembly, thereby defining a connector of the second anchoring assembly, and loops from the second portion of the second anchoring assembly back to the bridge node, thereby defining a fourth bridge.

[0071] In some applications, the system and / or device further includes a lock, and the tool is configured to adjust bridge lengths of the first bridge, the second bridge, the third bridge, and the fourth bridge by applying tension to the first tether and the second tether, and to lock the tension to the first tether and the second tether by locking the lock to the first tether and the second tether.

[0072] In some applications, each of the bridges includes a first bridge component and a second bridge component axially slidable relative to one another, and the implant further includes one or more adjustment mechanisms operably coupled to a respective one of the bridges such that, for each of the adjustment mechanisms, actuation of the adjustment mechanism adjusts the bridge length of the respective bridge by sliding the first bridge component and the second bridge component of the respective bridge relative to one another.

[0073] For some applications, for each adjustment mechanism, the adjustment mechanism includes a rotatable member, and the tool is configured to actuate the adjustment mechanism by rotating the rotatable member.

[0074] In some applications, for each of the bridges, the first bridge component is articulatable relative to the second bridge component.

[0075] In some applications, the implant further includes one or more adjustment mechanisms, each of which is operably coupled to at least one of the bridges such that, for each of the adjustment mechanisms, movement of a component of the adjustment mechanism along a first axis causes contraction of at least one of the bridges along a second axis, the second axis being orthogonal to the first axis.

[0076] In some applications, for each of the adjustment mechanisms, the adjustment mechanism components include a threaded bolt, and the tool is configured to cause contraction of at least one of the bridges along the second axis by rotating the bolt to cause movement of the bolt along the first axis.

[0077] For some applications, the implant further includes one or more adjustment mechanisms, each of which is operably coupled to at least one of the bridges in a Scott-Russell linkage.

[0078] In some applications, for each adjustment mechanism, the adjustment mechanism includes a threaded bolt, and the tool is configured to actuate the adjustment mechanism by rotating the bolt.

[0079] According to some applications, a method is provided for use with a valve disposed between an atrium and a ventricle of a subject's heart, the valve defining a valve orifice and having an annulus surrounding the valve orifice, the method including anchoring a first series of anchors of a first anchoring assembly within the atrium along a first portion of the valve annulus such that first connectors of the first anchoring assembly connect the first series of anchors to each other and extend along a first portion of the annulus.

[0080] In some applications, the method further includes anchoring a second series of anchors of a second anchoring assembly within the atrium along a second portion of the annulus such that second connectors of the second anchoring assembly connect the second series of anchors to each other and extend along a second portion of the annulus.

[0081] In some applications, the method further includes then transluminally advancing the tool into the heart.

[0082] In some applications, the system and / or device then includes positioning a distal end of a tool within the atrium over the valve orifice and using the tool to reshape the annulus by reducing a bridge length of a bridge connecting the first anchoring assembly to the second anchoring assembly.

[0083] In some applications, securing the first series of anchors along a first portion of the annulus includes positioning a curved portion of the first tether along the first portion of the annulus by securing the first series of anchors along the first portion of the annulus such that the curved portion of the first tether defines a first connector.

[0084] In some applications, securing the second series of anchors along the second portion of the annulus includes positioning a curved portion of the second tether along the second portion of the annulus by securing the second series of anchors along the second portion of the annulus such that the curved portion of the second tether defines a second connector.

[0085] In some applications, the bridge is a first bridge, and positioning the distal end of the tool over the valve orifice includes forming a first bridge from a first bridge portion of the first tether, forming a second bridge from a second bridge portion of the first tether, forming a third bridge from a third bridge portion of the second tether, and forming a fourth bridge from a fourth bridge portion of the second tether by positioning the distal end of the tool over the valve orifice, defining a bridge node at the distal end of the tool where the first bridge, second bridge, third bridge, and fourth bridge converge.

[0086] In some applications, positioning a distal end of the tool over the valve orifice includes engaging the tool with an adjustment mechanism coupled to the bridge and positioned over the valve orifice, and reducing a bridge length of the bridge includes reducing the bridge length of the bridge by actuating the adjustment mechanism using the tool.

[0087] In some applications, the bridge includes a first bridge component and a second bridge component, and reducing a bridge length of the bridge includes axially sliding the first bridge component relative to the second bridge component by actuating an adjustment mechanism using a tool.

[0088] The above methods can be performed in live animals or in simulations, such as cadavers, cadaver hearts, simulators (eg, simulated body parts, cardiac tissue), and the like.

[0089] This summary is intended to provide some examples and is not intended to limit the scope of the present invention in any way. For example, any features included in an example of this summary are not required by the claims unless the claims explicitly recite those features. Also, features, components, steps, concepts, etc. described in the examples in this summary and elsewhere in this disclosure can be combined in various ways. Various features and steps described elsewhere in this disclosure can be included in the examples summarized herein.

[0090] The present invention will be more fully understood from the following detailed description of the present invention taken together with the drawings. [Brief description of the drawings]

[0091] [Figure 1A] FIG. 1A is a schematic diagram of an exemplary system for use with an atrioventricular valve of a subject's heart, according to some applications, and an exemplary technique for use with the system. [Figure 1B] FIG. 1B is a schematic diagram of an exemplary system for use with an atrioventricular valve of a subject's heart, according to some applications, and an exemplary technique for use with the system. [Figure 2A] FIG. 2A is a schematic diagram of an exemplary system for use with an atrioventricular valve of a subject's heart, according to some applications, and an exemplary technique for use with the system. [Figure 2B] FIG. 2B is a schematic diagram of an exemplary system for use with an atrioventricular valve of a subject's heart, according to some applications, and an exemplary technique for use with the system. [Figure 2C] FIG. 2C is a schematic diagram of an exemplary system for use with an atrioventricular valve of a subject's heart, according to some applications, and an exemplary technique for use with the system. [Figure 2D] FIG. 2D is a schematic diagram of an exemplary system for use with an atrioventricular valve of a subject's heart, according to some applications, and an exemplary technique for use with the system. [Figure 3A]FIG. 3 is a schematic diagram of an exemplary system for use with an atrioventricular valve of a subject's heart, according to some applications, and an exemplary technique for use with the system. [Figure 3B] FIG. 3B is a schematic diagram of an exemplary system for use with an atrioventricular valve of a subject's heart, according to some applications, and an exemplary technique for use with the system. [Figure 3C] FIG. 3C is a schematic diagram of an exemplary system for use with an atrioventricular valve of a subject's heart, according to some applications, and an exemplary technique for use with the system. [Figure 3D] FIG. 3D is a schematic diagram of an exemplary system for use with an atrioventricular valve of a subject's heart, according to some applications, and an exemplary technique for use with the system. [Figure 4A] FIG. 4A is a schematic diagram of an exemplary system for use with an atrioventricular valve of a subject's heart, according to some applications, and an exemplary technique for use with the system. [Figure 4B] FIG. 4B is a schematic diagram of an exemplary system for use with an atrioventricular valve of a subject's heart, according to some applications, and an exemplary technique for use with the system. [Diagram 5] FIG. 5 is a schematic diagram of an exemplary system for use with an atrioventricular valve of a subject's heart, according to some applications, and an exemplary technique for use with the system. [Figure 6] FIG. 6 is a schematic diagram of an exemplary implant, according to some applications. [Figure 7A] FIG. 7A is a schematic diagram of an exemplary system for use with an atrioventricular valve, and an exemplary technique for use with the system, according to some applications. [Figure 7B] FIG. 7B is a schematic diagram of an exemplary system for use with an atrioventricular valve, according to some applications, and an exemplary technique for use with the system. [Figure 8A] FIG. 8A is a schematic diagram of an exemplary system for use with an atrioventricular valve, and an exemplary technique for use with the system, according to some applications. [Figure 8B]FIG. 8B is a schematic diagram of an exemplary system for use with an atrioventricular valve, according to some applications, and an exemplary technique for use with the system. [Figure 8C] FIG. 8C is a schematic diagram of an exemplary system for use with an atrioventricular valve, and an exemplary technique for use with the system, according to some applications. [Figure 8D] FIG. 8D is a schematic diagram of an exemplary system for use with an atrioventricular valve, and an exemplary technique for use with the system, according to some applications. [Figure 8E] FIG. 8E is a schematic diagram of an exemplary system for use with an atrioventricular valve, and an exemplary technique for use with the system, according to some applications. [Figure 8F] FIG. 8F is a schematic diagram of an exemplary system for use with an atrioventricular valve, and an exemplary technique for use with the system, according to some applications. [Figure 8G] FIG. 8G is a schematic diagram of an exemplary system for use with an atrioventricular valve, and an exemplary technique for use with the system, according to some applications. [Figure 9A] FIG. 9A is a schematic diagram of an exemplary system for use with an atrioventricular valve, according to some applications, and an exemplary technique for use with the system. [Figure 9B] FIG. 9B is a schematic diagram of an exemplary system for use with an atrioventricular valve, and an exemplary technique for use with the system, according to some applications. [Figure 10] FIG. 10 is a schematic diagram of an exemplary system for use with an atrioventricular valve, according to some applications, and an exemplary technique for use with the system. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0092] In the following description, various aspects of the present disclosure are described. For the purpose of explanation, specific structures and details are described in order to fully understand various aspects of the present disclosure. However, it will be apparent to those skilled in the art that the present disclosure can be practiced without the specific details presented herein. Well-known features may be omitted or simplified so as not to obscure the present disclosure. Furthermore, in order to avoid undue confusion due to too many reference numbers and lead lines on a particular drawing, some components may be introduced with one or more drawings and not be explicitly identified in all subsequent drawings that include the components.

[0093] Some of the concepts and applications disclosed herein relate to implants for use in an atrioventricular valve (e.g., mitral or tricuspid valve) of a subject. The figures show a mitral valve, purely by way of example. Such an implant may comprise two (or more) anchoring assemblies connected to one another by a bridge (or multiple bridges) having an adjustable bridge length. Each such anchoring assembly includes multiple anchors connected by connectors, and is configured to be secured by the anchors to respective portions of tissue around the valve (e.g., respective portions of the annulus, such as respective sides of the annulus) such that subsequent adjustment (e.g., reduction) of the bridge length reshapes the valve (e.g., shrinks the annulus).

[0094] Disclosed with reference to Figures 1A-6 are applications in which the bridges and connectors often include various tether portions slidably coupled to the anchors, and the bridge length may be adjusted by adjusting the tension in the tether. Disclosed with reference to Figures 7A-10 are applications in which the implants often include adjustment mechanisms operably coupled to the bridges, and the bridge length may be adjusted by actuating the adjustment mechanisms. The implants in the applications of Figures 7A-10 are typically advanced to the heart in a pre-assembled state, whereas the implants in the applications of Figures 1A-6 are typically assembled within the heart.

[0095] In the applications of Figures 1A-6 and 7A-10, the implant may be advanced transluminally and / or transcatheterically into the heart. In the applications of Figures 1A-6 and 7A-10, a driver may be used to secure the anchors to tissue. In the applications of Figures 1A-6 and 7A-10, when the implant is implanted, each of the bridges typically extends at least part way across the valve (e.g., into the atrium, across the valve orifice and / or leaflets). In the applications of Figures 1A-6 and 7A-10, adjustment of bridge length may be performed using a tool advanced into the implant within the heart.

[0096] Thus, according to some applications, a system is provided for use with a valve disposed between an atrium and a ventricle of a subject's heart. The system includes an implant, a driver, a tool, and often also a catheter advanceable transluminally into the heart. The implant may include (a) a first anchoring assembly and a second anchoring assembly, each including a plurality of anchors and a connector connecting the plurality of anchors to one another, and (b) one or more bridges connecting the first anchoring assembly to the second anchoring assembly and having an adjustable bridge length. The driver may be extendable through the catheter and is often further configured to secure the first anchoring assembly in the atrium at a first portion (e.g., a first side) of the valve using anchors of the first anchoring assembly and secure the second anchoring assembly in the atrium at a second side of the valve using anchors of the second anchoring assembly, such that each of the bridges extends at least partway across the valve. The tool is configured to adjust a distance between the first anchoring assembly and the second anchoring assembly by adjusting a bridge length of at least one of the bridges.

[0097] According to some applications, a method for use with a valve is further provided. In the atrium, a first series of anchors of a first anchoring assembly are secured in a first row (e.g., generally linear or arcuate) along a first portion of the annulus, e.g., such that a first connector of the first anchoring assembly connects the anchors of the first series to each other and extends along a first portion of the annulus. Also, in the atrium, a second series of anchors of a second anchoring assembly are secured in a second row along a second portion of the annulus, e.g., such that a second connector of the second anchoring assembly connects the anchors of the second series to each other and extends along a second portion of the annulus. Typically, the tool is then advanced transluminally into the heart. The distal end of the tool can be positioned within the atrium, e.g., over the orifice and / or leaflet of the valve. The tool can be used to reshape the annulus, e.g., by reducing the bridge length of the bridge connecting the first anchoring assembly to the second anchoring assembly.

[0098] In some applications, a first portion of the annulus underlies a first leaflet of the valve and a second portion of the annulus underlies a second leaflet of the valve, and reshaping the annulus draws the first and second leaflets toward one another. For example, when a mitral valve is undergoing a procedure, a first anchoring assembly can be secured to the mitral annulus at the base of the anterior mitral leaflet and a second anchoring assembly can be secured to the mitral annulus at the base of the posterior mitral leaflet, and reshaping the mitral annulus can draw the anterior and posterior mitral leaflets closer to one another. Similarly, when the tricuspid valve is undergoing a procedure, a first anchoring assembly may be secured to the tricuspid annulus at the base of the septal tricuspid leaflet and a second anchoring assembly may be secured to the tricuspid annulus at the base of the posterior tricuspid leaflet, where remodeling of the tricuspid annulus draws the septal and posterior tricuspid leaflets closer together and functionally removes the anterior tricuspid leaflet. Optionally, when the tricuspid valve is undergoing a procedure, a first anchoring assembly may be secured to the tricuspid annulus at the base of the septal tricuspid leaflet, a second anchoring assembly may be secured to the tricuspid annulus at the base of the posterior tricuspid leaflet and a third anchoring assembly may be secured to the tricuspid annulus at the base of the anterior tricuspid leaflet, where remodeling of the tricuspid annulus draws the septal, posterior and anterior tricuspid leaflets closer together. These methods can be performed in live animals or in simulations, eg, cadavers, cadaver hearts, simulators (eg, simulated body parts, cardiac tissue), and the like.

[0099] 1A-1B, 2A-2D, 3A-3D, 4A-4B, and 5, there are schematic diagrams of a system 100 for use with an atrioventricular valve 8 of a subject's heart, according to some applications, and techniques for use with the system 100. The system 100 includes at least two subassemblies 112, and often further includes a delivery instrument 150 that is transluminally advanceable to the heart and that is used to facilitate implantation of each subassembly (and often at least some assemblies). As described in more detail below, the subassemblies 112 are components of an implant 110, which may be assembled within the heart. The delivery instrument 150 often includes a driver 160 and a catheter (e.g., flexible tube) 170 within which (e.g., through) the driver is slidable.

[0100] FIG. 1A shows the implant 110 in its assembled state, e.g., after implantation in the valve 8. FIG. 1B shows, e.g., one of the subassemblies 112 before implantation. Each subassembly 112 includes a respective tether 130 and a respective set 118 of anchors 120. The suffixes a and b are used herein to designate an instance of a given element (e.g., an otherwise identical instance of an element) as one of the subassemblies or the other. For example, FIG. 1A shows the implant 110 including (i) a first subassembly 112a including tether 130a and set 118a of anchors 120 and (ii) a second subassembly 112b including tether 130b and set 118b of anchors 120. Each tether 130 has a first end portion 132, a second end portion 134, and a bend 136 between the end portions, at least in the assembled state of the implant 110.

[0101] As described in more detail below, in the assembled state of the implant 110, each subassembly 112 of the implant comprises (i) a respective anchoring assembly 140 including a plurality of anchors 120 and a connector 142 connecting the plurality of anchors to one another, and (ii) two bridges 144 connecting the first anchoring assembly to the second anchoring assembly. That is, the subassembly 112a includes (i) an anchoring assembly 140a including a plurality of anchors 120 and a connector 142a, and (ii) two bridges 144_i and 144_ii, and the subassembly 112b includes (i) an anchoring assembly 140b including a plurality of anchors 120 and a connector 142b, and (ii) two bridges 144_iii and 144_iv. As shown, the connectors 142 and the bridges 144 may be defined by various portions of the tether 130. Thus, the connectors 142 and the bridges 144 may be flexible.

[0102] In many cases, as described in more detail below, in the assembled state of the implant 110, the bridges 144 of all (e.g., both) subassemblies 112 converge at bridge node 138 where they are fixedly connected to each other by lock 146.

[0103] For completeness, in FIG. 1A, the reference numbers of each component of each subassembly are reproduced with and without its suffix, with a comma distinguishing between the unsuffixed and suffixed reference numbers. For example, tether 130a is tether 130 of subassembly 112a and is therefore labeled "130, 130a." However, to avoid cluttering the figures, FIGS. 2A-5 use only the suffixed reference numbers. (The suffix is ​​omitted from FIG. 1B, which shows subassembly 112, which can be either subassembly 112a or 112b.)

[0104] At least in the assembled state of implant 110, for each subassembly 112, anchors 120 are slidably coupled to tether 130, often coupled to curved portion 136. This slidable coupling may be achieved, for example, by the anchors being threaded onto tether 130. For some applications, anchors 120 and / or their slidable coupling to tether 130 are as described, mutatis mutandis, for one or more of the anchors and / or tethers described in U.S. Patent No. 6,399,433 to Kasher et al., and / or U.S. Patent No. 6,399,433 to Shafigh et al., filed March 17, 2021, each of which is incorporated herein by reference for all purposes.

[0105] Driver 160 often includes a flexible stem 162 and a driver head 164 configured to reversibly engage a driver interface (e.g., head) of anchor 120. Through this engagement, driver 160 is configured to drive a tissue engaging element of anchor 120 into tissue 10. For example, in applications where the tissue engaging element is helical, driver 160 may be configured to screw the tissue engaging element into tissue.

[0106] 2A shows curved portion 136a of tether 130a advanced distally from catheter 170, two anchors 120 of set 118a secured to cardiac tissue 10, and a driver 160 advancing a third anchor of the set through the catheter and driving the third anchor into the tissue. In some applications, curved portion 136a is advanced through and / or out of catheter 170 with a first anchor of set 118a already slidably coupled to tether 130a. For example, curved portion 136a can be advanced through and / or out of catheter 170 by driver 160 with first anchor 120 slidably coupled to the curved portion and with the driver engaged with the first anchor, e.g., the driver advances the curved portion by advancing an anchor.

[0107] Once the first anchor 120 of set 118a is secured, end portions 132a and 134a of tether 130a are positioned proximally (e.g., outside the heart) from curved portion 136a and typically extend transluminally outside the subject. In some applications, each subsequent anchor 120 is advanced into the heart (e.g., the atrium) by sliding the anchor over and along one of the end portions (in the application shown, end portion 132a) toward the first anchor. Often, after securing each anchor, driver 160 is withdrawn from the heart (e.g., from the subject's body) and coupled to the subsequent anchor.

[0108] For example, end portion 132a may extend through a first lumen 172 (e.g., a primary lumen) of catheter 170, and end portion 134a may extend through a second lumen (e.g., a secondary lumen) 174 of the catheter. As shown, lumen 172 can be sized to facilitate passage of anchor 120 and driver 160 therethrough, and lumen 174 can be narrower and / or have a smaller cross-sectional area than lumen 172.

[0109] Optionally, system 100 may be configured to facilitate advancement of subsequent anchors over either end portion of tether 130, for example, by allowing each end portion to be positioned or positioned within a lumen (e.g., a respective lumen, or the same lumen) that is sized to facilitate passage of anchor 120 and driver 160. It is hypothesized that such a configuration may advantageously allow a first anchor of a set to be anchored at a location determined to be the optimal center of tissue site / anchor fixation assembly 140, with subsequent anchors of the set being added on either side thereof (e.g., alternating). It is further hypothesized that such a configuration may advantageously allow a physician to make intra-procedural decisions regarding the boundaries of anchor fixation assembly 140, such as in response to information obtained during a procedure. For example, a physician may initially intend for a first anchor of a set to be a distal anchor (see below), but may then decide to fix subsequent anchors of the set beyond the first anchor.

[0110] Components and / or features of delivery device 150 (e.g., catheter 170 and / or driver 160) and / or anchor 120 may share one or more structural and / or functional features (e.g., one or more structural and / or functional features of the catheters, drivers, and / or anchors described therein) described in one or more of the following references, each of which is incorporated herein by reference. Patent Document 3 (Iflah et al.) Patent Document 4 (Brauon et al.) Patent Document 1 (Kasher et al.)

[0111] 2B-2D are schematic top views, looking down on the valve 8 from the atrium upstream of the valve, similar to the view in FIG. 1A, for example.

[0112] FIG. 2B shows subassembly 112a as assembled / implanted (e.g., fixation of anchors 120 of set 118a). Subassembly 112b can be assembled / implanted in the same manner, with modifications as needed. FIG. 2C shows both subassemblies assembled / implanted. In the embodiment shown, each anchor 120 of set 118a is fixed in a first row along the tissue of the heart, thereby positioning at least a portion of curved portion 136a along the tissue, and each anchor of set 118b is fixed in a second row along the tissue of the heart, from the first row across the valve 8, thereby positioning at least a portion of curved portion 136b along the tissue, from curved portion 136a across the valve 8.

[0113] As shown, once each set of anchors 120 is secured, end portions 132a and 134a of tether 130a and end portions 132b and 134b of tether 130b extend outside of the heart, typically outside of the subject.

[0114] The number of anchors 120 in each set 118 can be predetermined or can be determined in real time by a physician. Although the illustrated embodiment shows sets 118 having equal numbers of anchors 120, unequal numbers can be used. Similarly, while implant 110 is shown and described as including two subassemblies, a greater number of subassemblies (e.g., three subassemblies or four subassemblies) can be used, with modifications as needed.

[0115] Once both subassemblies are assembled / implanted, the tool 180 is then advanced transluminally into the heart, often by advancing the tool transluminally over and along the end portions 132a, 134a, 132b, and 134b until the distal end 182 of the tool is positioned within the atrium, such as over the orifice and / or leaflets of the valve 8 (FIG. 2D). That is, the tool 180 typically engages the implant 110 within the atrium. Often, this engagement occurs exclusively between the anchoring assembly 140a and the anchoring assembly 140b. Often, this advancement of the tool 180 defines a bridge node 138 at the distal end 182 of the tool where the tethers 130a and 130b (e.g., their end portions 132a, 134a, 132b, and 134b) converge. Bridge node 138 may be, for example, upstream of the valve orifice and / or on the leaflets of valve 8, part way between the row of anchors of set 118a and the row of anchors of set 118b.

[0116] At least in its implanted state, the implant 110 comprises (i) a first anchoring assembly 140a and a second anchoring assembly 140b, each of which comprises a plurality of anchors 120 and a connector 142 connecting the plurality of anchors to one another, and (ii) a bridge 144 connecting the first anchoring assembly to the second anchoring assembly. The connectors 142 and bridges 144 of the implant 110 are thereby often defined by various portions of the tether 130 and become more apparent upon advancement of the tool 180.

[0117] In some applications, as shown in FIGS. 1A, 2D, and 5, the first tether 130a may be (i) looping from bridge node 138 to a first portion (e.g., a first end) of first anchoring assembly 140a, thereby defining a first bridge 144_i (this portion of the tether may be referred to as a first bridge portion of the tether); (ii) looping from a first portion of the first anchoring assembly 140a to a second portion (e.g., a second end) of the first anchoring assembly, thereby defining a connector 142a; (iii) from the second portion of the first anchoring assembly 140a back to the bridge node 138, thereby defining a second bridge 144_ii (this portion of the tether may be referred to as a second bridge portion of the tether).

[0118] The second tether 130b similarly loops back along and from the second anchoring assembly 140b to define a third bridge 144_iii, a connector 142b, and a fourth bridge 144_iv.

[0119] The illustrated embodiment shows both anchoring assemblies 140 having generally similar lengths to each other, both extending similar distances along the annulus, with each of the anchoring assemblies extending approximately a quarter of the way along the annulus, however, the anchoring assemblies can have different lengths to each other, can extend different distances along the annulus from each other, and can each extend more or less than a quarter of the way along the annulus.

[0120] In many cases, as shown, the anchors 120 of a given set 118 are arranged on their respective tethers 130 in a series and secured to tissue in a series. For each series, the anchor 120 at one end of the series may be considered a first terminal anchor of the series and the anchor 120 at the opposite end of the series may be considered a second terminal anchor of the series. Throughout this application (including the specification and claims), the terms "first terminal anchor" and "second terminal anchor," in the context of a given series of anchors, do not necessarily indicate the order in which these two anchors are advanced and / or secured.

[0121] In some applications, the portion of anchoring assembly 140 where bridge 144 extends toward bridge node 138 is the terminal anchor. That is, in some applications, for a given subassembly 112, (i) one bridge (i.e., one bridge portion of the tether) extends between bridge node 138 and the first terminal anchor of each series, and (ii) the other bridge (i.e., the other bridge portion of the tether) extends between the bridge node and the second terminal anchor of each series.

[0122] In some applications, as shown, the distal anchor of a given anchorage assembly 140 defines the end of that anchorage assembly.

[0123] Each bridge 144 has a bridge length between its respective anchoring assembly 140 and bridge node 138. Tool 180 is used to adjust (e.g., reduce) the bridge length of one or more bridges 144 by applying tension to tethers 130a and 130b (e.g., by pulling end portions 132a, 134a, 132b, and 134b). Due to the fixation of anchors 120 to tissue 10, tissue 10 is thereby remodeled. For example, in applications where tissue 10 is tissue of an annulus of valve 8, the reduction in bridge length remodels (e.g., shrinks) the annulus. FIG. 5 illustrates valve 8 after shrinkage by system 10, which will be discussed below. However, prior to this, several other optional features of system 100 will be described.

[0124] In some applications, each tether 130 can be tensioned independently of or in cooperation with other tethers of implant 110. Additionally, for a given tether, end portion 132 can be pulled (e.g., tensioned) independently of or in cooperation with end portion 134. For example, tool 180 can be configured to selectively or differentially tension tethers 130a and 130b by selectively or differentially pulling end portions 132a, 134a, 132b, and 134b.

[0125] 3A-3D are schematic representations of various ways in which the implant 110 can be contracted, with dashed lines representing the shape of the implant (e.g., its bridges 144) at implantation and solid lines representing the shape of the implant after contraction. FIG. 3A shows a hypothetical contracted shape of the implant 110 when all end portions (i.e., both end portions of both tethers) are pulled in concert, resulting in a similar amount of shortening of all bridges 144. FIG. 3B shows a hypothetical contracted shape of the implant 110 when end portion 134a is pulled more than the other three end portions, and bridge 144_ii is shortened more than the other three end portions. FIG. 3C shows a hypothetical contracted shape of the implant 110 when end portions 134a and 134b are pulled more than end portions 132a and 132b, and bridges 144_ii and 144_iv are shortened more than bridges 144_i and 144_iii. 3D shows a hypothetical contracted shape of implant 110 with end portions 134a and 132b pulled further than end portions 132a and 134b and bridges 144_ii and 144_iii shortened relative to bridges 144_i and 144_iv, which is hypothesized to render system 100 advantageously flexible and promote a high degree of control over the manner in which cardiac tissue, such as valve annulus, is remodeled.

[0126] In some applications, the dual functions of independent and coordinated pulling may be facilitated by an extracorporeal control interface 190. The interface 190 may be located at the proximal portion 184 of the tool 180 and may be integrated into the handle 186 of the tool, for example, as shown. The interface 190 is operable by a user, such as a surgeon or interventional cardiologist.

[0127] Interface 190 may include multiple tether controllers 192, each configured to apply tension to a respective individual end portion of tether 130 of implant 110. For example, and as shown, in applications in which implant 110 includes tethers 130a and 130b, interface 190 may include four tether controllers 192: one for end portion 132a, one for end portion 134a, one for end portion 132b, and one for end portion 134b. In some applications, each tether controller 192 includes a respective wheel (as shown), knob, or similar actuation that pulls on a respective tether end portion.

[0128] Interface 190 may include a collective tether controller 194, actuation of which pulls all of the end portions collectively. For example, controller 194 may be used to achieve the result shown in FIG. 3A. Controller 194 may be used in conjunction with controller 192 or without controller 192. For example, controller 194 may be used to achieve a particular amount of overall contraction of the annulus of valve 8, and one or more of controllers 192 may be used (before and / or after) to achieve a more particular change in the shape of the annulus (e.g., as described with reference to FIGS. 3B-3C).

[0129] Interface 190 may include an engagement controller 196 configured to reversibly engage and disengage the interface with tether 130, e.g., to reversibly engage and disengage controllers 192 and 194 from the end portion. Controller 196 may be used to disengage interface 190 (e.g., its controllers 192 and 194) from tether 130, e.g., to facilitate sliding of tool 180 over and along the tether into the heart, and then to engage the interface with the tether to facilitate tensioning of the end portion of the tether and retraction of implant 110.

[0130] In some applications, the distal end 182, and therefore the bridge node 138, may be positioned (and repositioned) at least partially independent of the location at which the anchor 120 is secured. This positioning may be performed as the distal end 182 is advanced into the heart (e.g., as the distal end is brought proximate to the valve 8) and / or may be performed when the distal end is already in the heart (e.g., after the distal end has already been positioned at the valve 8). This positioning may be facilitated by applying tension to one or more of the end portions of the tether 130 while relaxing tension on one or more of the end portions. This positioning may alternatively or additionally be facilitated by steering the distal end 182 of the tool 180 and / or by steering the catheter in which the tool 180 is disposed. Such steering may be accomplished by means known in the art, such as via one or more pull wires extending through the tool 180 and / or the catheter in which the tool is disposed, with modifications as needed.

[0131] 4A-B illustrate generally various ways in which repositioning of bridge nodes 138 can contract implant 110, with dashed lines representing the initial shape of implant 110 (e.g., its bridges 144) when distal end 182 reaches valve 8 and solid lines representing the shape of the implant after repositioning of distal end 182. Arrows indicate the resulting movement of bridge nodes 138 from their initial positions to subsequent positions. As shown, repositioning of bridge nodes 138 lengthens at least one of bridge portions 144 and shortens at least another of the bridge portions. Repositioning can move distal end 182 and bridge nodes 138 away from one of anchoring assemblies 140 and toward another of the anchoring assemblies. Figure 4A shows an embodiment in which distal end 182, and therefore bridge node 138, is repositioned toward anchorage assembly 140a, lengthening bridges 144_iii and 144_iv and shortening bridges 144_i and 144_ii. Figure 4B shows an embodiment in which distal end 182, and therefore bridge node 138, is repositioned toward one particular end of anchorage assembly 140a.

[0132] It is hypothesized that the ability to reposition bridge node 138 provides one or more advantages. These advantages may be a direct result of the position of bridge node 138, for example, by having lock 146 and / or bridge 144 positioned over the orifice and / or leaflets of valve 8 to mechanically prevent the leaflets from flailing within the atrium.

[0133] Alternatively or additionally, these benefits may be the product of different angles and lengths of the bridges 144 resulting from repositioning of the bridge nodes 138, which can provide additional control over contraction of different portions of the annulus. For example, as compared to the initial center position of the bridge nodes 138, positioning of the bridge nodes as shown in FIG. the contraction of the anchoring portion 140a caused by a given amount of tension on the end portions 132a and 134a of the tether 130a can be increased (in absolute terms and / or relative to the effect of tension on the bridge lengths of the bridges 144_i and 144_ii); and / or -Increases the amount that the bridge length of bridges 144_iii and 144_iv is shortened by a given amount of pulling on end portions 132b and 134b (absolutely and / or relative to the amount that pulling contracts anchoring portion 140b).

[0134] Once the desired adjustment (e.g., contraction) of the tissue 10 (e.g., valve 8) is achieved, the tension applied to the tether 130 is locked in place by locking a lock 146 to the tether (FIG. 5). The lock 146 can be coupled to the distal end 182 of the tool 180 and can be locked to the tether by actuation of a lock controller 198 at a proximal portion 184 of the tool (FIG. 5). The lock controller 198 can be a component of the interface 190.

[0135] In some applications, as shown, tool 180 is also used to sever excess tether 130 proximally from lock 146. In such applications, tool 180 may be configured such that a single action by an operator (e.g., actuation of lock controller 198) locks lock 146 and cuts the excess tether.

[0136] In some applications, the locking and / or cutting operations of lock 146 and / or tool 180 may share elements and / or features described in U.S. Patent No. 5,393,363 (Brauon et al.), which is incorporated herein by reference.

[0137] In some applications, lock 146 includes multiple locking elements, each of which is independently lockable by tool 180, such that the lock can be locked to each tether 130 independently of the others, e.g., the lock can be locked to each bridge portion (e.g., each bridge 144) independently of the others.

[0138] In the illustrated application, these various controllers may be mechanically coupled to the elements they control. However, alternatively or additionally, interface 190 may comprise a user interface for one or more computed control elements that control the operation of the system elements. For purposes of this application, the term "computer control element," and the equivalent term "computer controller," refer to a computational circuit or element for controlling the operation of the mechanical and / or electrical components of the system. The computer control element includes a processing unit operatively associated with a non-tangible computer-readable storage medium. The storage medium stores instructions that, when executed by the processing unit, perform operations that control the operation of the mechanical and / or electrical components of the system. For example, the instructions may include instructions to distally advance one or more components of the system or proximally retract one or more components of the system. In such an embodiment, interface 190 may be operatively associated with one or more computed control elements and may be configured to receive user input that triggers the execution of specific instructions stored in the storage medium.

[0139] Thus, throughout this application, interface 190 can include one or more mechanical controllers, such as knobs, switches, levers, sliders, and / or buttons (e.g., as shown), and / or can include one or more electronic controllers, such as a keyboard, mouse, buttons, and / or touch screen. Similarly, a given controller illustrated herein as one type of mechanical controller may optionally be provided as another type of mechanical controller.

[0140] Additionally, it should be noted that the shape and configuration of the interface 190 (e.g., the handle 186) may differ from that shown. For example, configurations that do not incorporate a handle shaped to hold the interface 190 are possible.

[0141] Reference is now made to FIG. 6, which is a schematic diagram of implant 110' according to some applications. Implant 110' is as typically described for implant 110 unless otherwise noted. Similarly, except with the suffix "'", components of implant 110' that are named and numbered identically to components of implant 110 are as typically described for components of implant 110 unless otherwise noted. The anchorage assemblies of each subassembly of implant 110' further include a sleeve 122. For example, in the application shown, anchorage assembly 140a' of subassembly 112a' further includes sleeve 122a, and anchorage assembly 140b' of subassembly 112b' further includes sleeve 122b. Sleeve 122 may be flexible and may include a polymer and / or fabric.

[0142] In each subassembly 112 of implant 110', curved portion 136 of tether 130 extends along sleeve 122 by extending through the lumen of the sleeve or by weaving along the sidewall of the sleeve (as shown). In some applications, anchoring assembly 140 is secured by anchor 120 being advanced from the lumen of the sleeve, through the wall of the sleeve, and into tissue 10, for example, similar to that described in U.S. Patent No. 5,399,633 (Zipory et al.) and / or U.S. Patent No. 5,399,633 (Sheps et al.), mutatis mutandis, each of which is incorporated herein by reference. In such applications, anchor 120 of implant 110' may be slidably coupled to curved portion 136 by sleeve 122 being slidably coupled to the curved portion. In such applications, the sleeve 122 of a given anchorage assembly 140' may define the connectors 142' of that anchorage assembly (eg, connector 142a' of anchorage assembly 140a' and connector 142b' of anchorage assembly 140b').

[0143] In some applications, as shown, the portions of each anchoring assembly 140a' and 140b' where bridge 144 extends toward bridge node 138 are at the ends of sleeve 122, and these may be spaced further apart than the terminal anchors of the anchoring assemblies. That is, in some applications, for a given subassembly 112', (i) one bridge (i.e., one bridge portion of the tether) extends between bridge node 138 and one end of the sleeve, and (ii) the other bridge (i.e., the other bridge portion of the tether) extends between the bridge node and the other end of the sleeve. For example, the bridge portion of the tether may extend from an open end of the lumen of the sleeve. Optionally, the bridge portions of the tether may extend laterally through the wall of the sleeve, e.g., from sites closer to each other than the ends of the sleeve.

[0144] The connector 142 of the implant 110 is axially contractible, for example, in response to the pulling of the tether 130. That is, the connector 142 shortens as the tether 130 is under tension and slides past the distal anchor of the anchoring assembly. In some applications, the connector 142' of the implant 110' is also axially contractible. However, in some applications, the connector 142' may be resistant to axial contraction. For example, the sleeve 122 may resist compression in response to the tension of the tether 130.

[0145] 1A-2D and 5 show valve 8, system 100 and implant 110 as the mitral valve of the heart, with implant 110' being used in the mitral valve, and system 100 and these implants may be used in the tricuspid valve of the heart as well.

[0146] 7A-B, 8A-8G, 9A-9B, and 10, there are schematic diagrams of a system 200 for use with an atrioventricular valve 8, and techniques for use with the system, according to some applications. The system 200 includes an implant 210, and often further includes a delivery instrument 250 that is transluminally advanceable to the heart and used to facilitate implantation of the implant 210. The delivery instrument 250 often includes a driver 260 and a catheter (e.g., flexible tube) 270 through which the driver is slidable.

[0147] Figure 7A shows the implant 210 in its expanded state, for example after implantation in the valve 8. Figure 7B shows the implant 210 in its contracted state, toward which the implant will subsequently translate to reshape tissue, for example, the valve annulus. For clarity, Figures 7A-7B do not show the valve 8 or other anatomical structures.

[0148] At least when implanted, the implant 110 comprises (i) at least two anchoring assemblies 240, each including a plurality of anchors 220 and a connector 242 connecting the plurality of anchors to one another, and (ii) one or more bridges 244 connecting the anchoring assemblies to one another. Often, each bridge 244 is connected to at least one other bridge at a bridge node 238. Often, at each bridge node, the implant 210 comprises a respective adjustment mechanism 230, described below. In the application shown in Figures 7A-9B, the implant 210 has exactly two anchoring assemblies 240, exactly four bridges 244 connected to one another in pairs at exactly two bridge nodes 238, with an adjustment mechanism 230 at each of the bridge nodes. Figure 10 shows another application designated implant 210', which comprises only two bridges 244 connected to one another at one bridge node 238.

[0149] Driver 260 often comprises a flexible stem 262 and a driver head 264 configured to reversibly engage a driver interface (e.g., defined by head 222) of anchor 220. Components and / or features of delivery device 150 (e.g., catheter 170 and / or driver 160) and / or anchor 120 may share one or more structural and / or functional features described in one or more of the following references (e.g., one or more structural and / or functional features of the catheters, drivers, and / or anchors described therein), each of which is incorporated herein by reference. Patent Document 3 (Iflah et al.) Patent Document 4 (Brauon et al.) Patent Document 1 (Kasher et al.)

[0150] In some applications, the implant 210 is delivered transluminally with the anchors 220 already coupled to the connectors 242. For example, and as shown, each anchor 220 may be rotatably coupled to the connectors 242, with the anchor's head 222 on one side of the connector, the anchor's tissue engaging element 224 on the other side of the connector, and the anchor's neck 226 extending through the connector. In such applications, the driver 260 can secure each anchoring assembly 240 to the tissue 10, for example, by applying a torque to the head 222 to screw the tissue engaging element 224 into the tissue such that the neck 226 is free to rotate within the connector 242.

[0151] Optionally, anchors 220 may be delivered transluminally independent of implant 110. For example, once implant 110 is positioned within the atrium, each anchor 220 may be advanced into the implant and driven through connector 242 into tissue 10.

[0152] 8A-8G show at least some steps of a technique for use with implant 210, according to some applications. Fig. 8A shows implant 210 delivered to the atrium and positioned on the upstream side of valve 8, and tool 260 used to secure one of anchors 220 to tissue 10. Figs. 8B-8D show tool 260 (e.g., its driver head 264) moving sequentially to other anchors 220 and securing them to tissue.

[0153] The anchors 220 of one anchoring assembly 240 can be considered to be secured in a first row along the heart tissue, and the anchors of the other anchoring assembly can be considered to be secured in a second row along the heart tissue from the first row across the valve 8. In the embodiment shown, each anchoring assembly 240 includes two anchors 220, although a greater number of anchors per anchoring assembly can be used.

[0154] Each bridge node 238 and each adjustment feature 230 can be partway between the first and second rows of anchors (e.g., partway between anchor fixation assemblies 240). Often, the implant 210 is implanted such that each bridge node 238 and each adjustment feature 230 is disposed on the upstream side of the valve orifice and / or leaflets of the valve 8.

[0155] Once the implant 210 is secured, at least one tool 280 is then advanced transluminally into the heart, for example via catheter 270, until the tool engages adjustment mechanism 230 (FIG. 8F). Tool 280 often engages adjustment element 230 in the atrium, such as over the orifice and / or leaflets of valve 8. Often, this engagement occurs exclusively between anchorage assemblies 240. Tool 280 is then used to actuate adjustment mechanism 230 (described below), which shortens bridge 244 (bridge length d2 in FIG. 7B is less than bridge length d1 in FIG. 7A), thereby drawing anchorage assemblies 240 and the tissue portions to which they are secured toward one another (FIG. 8G).

[0156] In the application shown, two tools 280 engage each of the two adjustment mechanisms 230 in parallel, for example, allowing for simultaneous and / or back-and-forth adjustment of the two adjustment mechanisms. In some applications, however, a single tool is used to engage and adjust each adjustment mechanism 230. In either case, the implant 210 allows for independent adjustment of each adjustment mechanism, thereby facilitating differential contraction of different portions of the annulus.

[0157] In some applications, and as shown, each bridge 244 includes a first bridge component 244a and a second bridge component 244b coupled to one another in a manner that promotes axial sliding relative to one another. For example, and as shown, one of the bridge components (bridge component 244a in the illustrated embodiment) may define an axial slot 238 or groove, and the other of the bridge components (bridge component 244b in the illustrated embodiment) may define a bearing that protrudes into (e.g., through) the slot or groove. In such applications, actuation of the adjustment mechanism 230 adjusts the bridge length of the bridge 244 to which it is coupled by sliding the bridge components 244a and 244b relative to one another. In some applications, this configuration of the bridge components relative to one another can be considered a telescoping arrangement.

[0158] In some applications, in addition to the axial sliding described above, bridge component 244a is articulatable relative to bridge component 244b for each bridge 244. In some applications, bridge component 244a is not articulatable relative to bridge component 244b, e.g., the bridge components are movable relative to each other only by axial sliding.

[0159] In some applications, and as shown, the connection between each bridge 244 (eg, each bridge component 244b) and the anchoring assembly 240 (eg, connector 242) is an articulated connection.

[0160] In some applications, and as shown, at each bridge node 238, a respective adjustment mechanism 238 is coupled to two respective bridges 244 (e.g., an adjustment mechanism couples two bridges together). In some applications, the coupling is such that actuation of the adjustment mechanism adjusts the bridge length of both bridges. However, in other such applications, the coupling is such that actuation of the adjustment mechanism adjusts the bridge length of only one of the bridges, e.g., one of the bridges having an adjustable bridge length and one of the bridges having a fixed bridge length.

[0161] In some applications, the adjustment mechanism 230 is operably coupled to the bridge 244 such that movement of an element, such as the bolt 232 of the adjustment mechanism along axis ax1, causes contraction of the bridge 244 (e.g., sliding of bridge component 244b) along an axis ax2 that is orthogonal to axis ax1. As shown, in some applications, this is accomplished by operably coupling (1) the sliding connection of bridge element 244b to bridge element 244a with (2) a linker 236 that is articulably connected to (i) the bolt 232 at one end and (ii) the bridge element 244b at the other end. In some applications, this arrangement is a Scott-Russell linkage.

[0162] In some applications, the adjustment mechanism 230 comprises a rotatable member and is actuable by rotating the rotatable member. In some such applications, the rotatable member is a bolt 232. For example, the bolt 232 may be a threaded bolt attached to the mount 234 such that rotation of the rotatable member moves the rotatable member along an axis ax1 relative to the mount 234 (and often relative to the bridge element 244a), thereby causing the bridge 244 to retract inwardly. The mount 234 may be fixedly coupled to the bridge element 244a.

[0163] Figures 8A-8G show valve 8 as the mitral valve of the heart, where system 200 and implant 210 have been used, and system 200 and implant 210 (implant 210' described herein below) may likewise be used in the tricuspid valve of the heart. Figures 9A-9B show this embodiment, where valve 8 is a tricuspid valve. Figure 9A shows implant 210 after it has been secured to the annulus of the tricuspid valve, and Figure 9B shows the implant after subsequent adjustment, subject to the resulting contraction of the tricuspid valve.

[0164] In some applications, and as shown in implant 210, the implant's connector (e.g., connector 242) is generally straight and anchor 220 is secured in a generally straight line. In some applications, and as shown in implant 210, the implant's connector (e.g., connector 242') is curved and anchor 220 is secured in a generally arcuate line.

[0165] Implant 210 is shown as including two anchors 220 per anchorage assembly 240, and implant 210' is shown as including three anchors per anchorage assembly. It should be understood that in some applications, each anchorage assembly of implant 210 or 210' may include a greater number of anchors. Additionally, in some applications, implant 210 or 210' may include more anchors in one anchorage assembly than in another (e.g., other) anchorage assembly. For example, one anchorage assembly may have two anchors and the other anchorage assembly may have three anchors.

[0166] In some applications, connectors 242 and / or 242' are rigid. In some applications, connectors 242 and / or 242' are semi-rigid. In some applications, connectors 242 and / or 242' are flexible. In some applications, connectors 242 and / or 242' are non-conformally flexible, e.g., more flexible in the atrioventricular direction than in the medial-lateral direction, allowing the connectors to conform to the shape of the annulus while retaining the ability to pull the annulus from the inside during contraction.

[0167] In some applications, bridge 244, its connection to anchorage assembly 240, and / or its connection to adjustment mechanism 230 are rigid in at least one plane, such as, for example, the plane in which connectors 242 or 242' lie. For example, as shown, bridge 244 can comprise one or more rigid components and / or can be articulably (e.g., hingedly) connected to the adjustment mechanism and / or connectors.

[0168] Those skilled in the art will appreciate that the present invention is not limited to what has been particularly shown and described above. Rather, the scope of the present invention includes both combinations and subcombinations of the various features described above, as well as variations and modifications thereof that are not present in the prior art and that would occur to one of skill in the art upon reading the above description. Furthermore, the treatment techniques, methods, acts, steps, etc. described or suggested herein can be performed in live animals or in non-living simulations, such as cadavers, cadaver hearts, simulators (e.g., simulated body parts, tissues, etc.).

Claims

1. 1. A system for use with a valve disposed between an atrium and a ventricle of a subject's heart, comprising: a catheter advanceable transluminally to the heart; an implant deployable from the catheter in the heart, a first anchoring assembly and a second anchoring assembly, each of the first anchoring assembly and the second anchoring assembly comprising: A plurality of anchors; a connector connecting the anchors to each other; a first anchoring assembly and a second anchoring assembly comprising: a bridge connecting the first anchoring assembly to the second anchoring assembly and having an adjustable bridge length; and an implant comprising: a driver extendable through the catheter and configured to use the anchors of the first anchoring assembly to anchor the first anchoring assembly in the atrium on a first side of the valve and to use the anchors of the second anchoring assembly to anchor the second anchoring assembly in the atrium on a second side of the valve such that the bridge extends at least partially across the valve; and a tool advanceable transluminally into the heart and configured to adjust the distance between the first anchoring assembly and the second anchoring assembly by adjusting the bridge length of the bridge; Including, the system.

2. 2. The system of claim 1, wherein the valve has an annulus and leaflets, the annulus surrounding an orifice within which the leaflets are disposed, and the tool is configured to engage the implant above the orifice and within the atrium.

3. The system of claim 1, wherein the valve has an annulus, and the tool is configured to constrict the annulus by adjusting the bridge length.

4. The system of claim 1, wherein the valve has an annulus, a first leaflet and a second leaflet, the annulus surrounding a valve orifice within which the first leaflet and the second leaflet are disposed, and the tool is configured to reshape the annulus by adjusting the bridge length in a manner to retract the first leaflet and the second leaflet toward each other.

5. The system of claim 1 , wherein the tool is configured to exclusively engage the implant between the first anchoring assembly and the second anchoring assembly.

6. The system of claim 1 , wherein the connectors of each of the anchoring assemblies are rigid.

7. The system described in claim 1, wherein the connectors of each of the anchor fixing assemblies are semi-rigid.

8. The system of claim 1 , wherein the connectors of each of the anchoring assemblies are flexible.

9. The system described in claim 1, wherein the connectors of each of the anchor fixing assemblies are non-conformally flexible.

10. The system of claim 1, wherein the connectors of each of the anchor fixing assemblies comprise a polymer.

11. The system of claim 1 , wherein the connector of each of the anchoring assemblies is axially contractible.

12. The system of claim 1 , wherein the connectors of each of the anchoring assemblies are resistant to axial contraction.

13. The system of claim 1 , wherein the bridge is articulably connected to one of the first anchoring assembly and the second anchoring assembly.

14. The system of claim 1, wherein the bridge is slidably connected to one of the first anchor fixing assembly and the second anchor fixing assembly.

15. the bridge being a first bridge extending from a first portion of the first anchorage assembly; The system of claim 1 , wherein the implant further comprises a second bridge extending from a second portion of the first anchorage assembly.

16. the bridge comprising a first bridge component and a second bridge component axially slidable relative to one another; 2. The system of claim 1, wherein the implant further comprises one or more adjustment mechanisms, each of the adjustment mechanisms operably coupled to the bridge such that, for each of the adjustment mechanisms, actuation of the adjustment mechanism adjusts the bridge length of the bridge by sliding the first bridge component and the second bridge component of the bridge relative to one another.

17. The system of claim 1, wherein the bridge is a first bridge of one or more bridges of the implant, the implant further including one or more adjustment mechanisms, each of the adjustment mechanisms operably coupled to at least one of the bridges such that, for each of the adjustment mechanisms, movement of a component of the adjustment mechanism along a first axis causes contraction of at least one of the bridges along a second axis, the second axis being perpendicular to the first axis.

18. The system of claim 1, wherein the bridge is a first bridge of one or more bridges of the implant, and the implant further includes one or more adjustment mechanisms, each of the adjustment mechanisms operably connected to at least one of the bridges in a Scott Russell linkage.

19. The system of claim 1, wherein the tool is transluminally advanceable to the implant and configured to engage the implant within the atrium.

20. The system of claim 1, wherein the bridge comprises a tether.

21. The system of claim 20, wherein adjusting the bridge length of the tether includes adjusting the tension of the tether.

22. The system of claim 21, further comprising a lock, and wherein the tool is configured to lock the tension in the tether by engaging the lock to the tether.

23. The system of claim 20, wherein adjusting the bridge length of the tether includes applying tension to the tether.

24. The bridge is a first bridge, The implant comprises: a third anchorage assembly, A plurality of anchors; a connector for connecting the anchors of the third anchorage assembly to one another; and a third anchoring assembly comprising: a second bridge connecting the third anchoring assembly to an anchoring assembly selected from the group of the first anchoring assembly and the second anchoring assembly, the second bridge having an adjustable bridge length; Further equipped with 2. The system of claim 1, wherein the tool is configured to adjust the distance between the first anchoring assembly and the selected anchoring assembly by adjusting the bridge length of the second bridge.

25. A system for use with a valve disposed between an atrium and a ventricle of a subject's heart, comprising: a catheter advanceable transluminally to the heart; an implant deployable from the catheter in the heart, A plurality of anchoring assemblies, each of the anchoring assemblies comprising: A plurality of anchors; a connector connecting the anchors of the anchorage assembly to one another; a plurality of anchoring assemblies comprising: a plurality of bridges connecting the anchoring assemblies to one another, each of the bridges having an adjustable bridge length; and an implant comprising: a driver extendable through the catheter, the driver being configured to, for each of the anchoring assemblies, secure the implant within the atrium using the anchors of the anchoring assemblies to secure the anchoring assembly within the atrium such that the bridge extends at least partially across the valve between the anchoring assemblies; and a tool advanceable transluminally into the heart and configured to adjust the distance between the first anchoring assembly and the second anchoring assembly by adjusting the bridge length of the bridge; Including, the system.

26. The plurality of anchor fixing assemblies, a first anchorage assembly; one or more other anchoring assemblies; Equipped with 26. The system of claim 25, wherein each of the plurality of bridges connects the first anchoring assembly to one of the one or more other anchoring assemblies.

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