Fasteners for percutaneous devices

Abstract

The guide assembly (100) is transluminally advanceable to the subject's heart. The guide assembly includes (i) a guide frame (110) deployable within the heart, (ii) one or more fasteners (40) secured to the guide frame, each fastener defining a closed loop (28), and (iii) a guide rail (102) threaded through the fasteners such that deployment of the guide frame to a site positions the guide rail along tissue (10). The tools (50, 56) are configured to fasten an implant (160) along tissue while guided by the guide rails, and secure the implant to the tissue such that the implant is coupled to the guide frame by being disposed through the loops of the fasteners. The fasteners are unlockable within the heart, allowing the guide frame to be decoupled from the implant. Other implementations are also described.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 63 / 140,226, filed January 21, 2021, entitled "Fasteners for Percutaneous Devices" by Herman et al., the contents of which are incorporated herein by reference in their entirety for all purposes. [Background technology]

[0002] Some percutaneous techniques, including transluminal techniques such as transcatheter cardiac intervention, require components to be decoupled from one another while in the body of a treated subject. For example, it may be advantageous for a tool that delivers and / or manipulates an implant to be securely coupled to the implant until a particular time, and then securely decoupled from the implant until the tool is removed from the subject. In some instances, components exert significant forces on their couplings before and during decoupling. In some instances, it is advantageous for the decoupling mechanism itself not to cause movement of the components that are decoupled from one another. Summary of the Invention

[0003] This summary is intended to provide some examples and is not intended to limit the scope of the invention in any way. For example, any features included in the examples 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 of 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. [Means for solving the problem]

[0004] In some applications, fasteners are described for use with percutaneous devices, including implants and delivery devices or systems for such implants. The fasteners may comprise longitudinal members, the curved portions of which can be formed into loops that resist expansion and / or release until purposefully released, after which they become readily expandable and / or releasable.

[0005] The longitudinal member may comprise a braided and / or twisted material, such as a cord. The channel may extend laterally through the longitudinal member at a channel site disposed between two ends of the longitudinal member. In some applications where the longitudinal member comprises a braided material, the longitudinal member may be threaded between strands of the braid, i.e., the channel is defined between strands of the braid. The loop is formed by threading a first end of the longitudinal member through the channel, such that a curved portion extends in a loop away from the first end and the channel toward a second end of the longitudinal member and the channel site.

[0006] A rod can extend laterally through the first end of the longitudinal member to prevent the loop from expanding and / or opening (ie, locking the fastener).

[0007] In some applications, the first end extends from the channel (i.e., through and beyond the channel) in a direction away from the channel section and the bend of the loop. In some such applications, the rod extends laterally through the portion of the first end that extends from the channel, such that the rod prevents the loop from expanding by lying across the opening of the channel. In some applications, the first end also passes back through the channel and the rod extends through two sections of the first end.

[0008] In some applications, the first end loops around the second end rather than passing through a channel in the second end, for example, in some such applications the rod extends through two sections of the first end on either side of the loop.

[0009] For some applications, the rod can extend laterally through a portion of the first end disposed within the channel to prevent expansion of the loop by securing a portion of the first end to a wall of the channel, and the fastener can be unlocked by withdrawing the rod from the first end of the longitudinal member.

[0010] In some applications, a fastener is used to constrain the implant in a crimped state by placing a loop of the fastener around the implant. The implant can be biased to an expanded state, which causes the implant to self-expand without the fastener constraining the implant. In some applications, the implant is delivered to the subject's heart in its crimped state (e.g., in a catheter) while constrained by the fastener, and once the implant is positioned in the heart, the implant can self-expand by removing the rod from the longitudinal member, which enlarges the loop or releases it completely.

[0011] In some applications, the guide assembly is transluminally advanceable to the subject's heart. The guide assembly includes (i) a guide frame deployable within the heart, (ii) one or more fasteners secured to the guide frame, each fastener defining a closed loop, and (iii) a guide rail. The guide rail may be secured (e.g., threaded) by the fastener such that deployment of the guide frame at the site positions the guide rail along the tissue. The tool is configured to position the implant along the tissue while guided by the guide rail and secure the implant to the tissue. The securement may be coupled to the guide frame by disposing the implant through a loop of the fastener. The fastener is unlockable within the heart, allowing the guide frame to be decoupled from the implant.

[0012] Thus, according to some applications, a system and / or device is provided that includes a fastener for use in a subject's heart, the fastener including a rod and a longitudinal member.

[0013] The longitudinal member can define (i) a first end comprising the first end of the longitudinal member, (ii) a second end, (iii) a curved portion, and (iv) a channel portion disposed between the second end and the curved portion and defining a channel extending laterally through the longitudinal member.

[0014] The longitudinal member can be positioned such that the curved portion extends away from the second end and the channel portion in a loop toward the first end, and the first end extends from the curved portion and through the channel, thereby closing the loop.

[0015] The rod can extend laterally through the first end such that the rod prevents the first end from sliding through the channel.

[0016] For some applications, the longitudinal member is a first longitudinal member of a set of longitudinal members of the fastener.

[0017] For some applications, the collection further includes a second longitudinal member defining a first end including the first end of the second longitudinal member, a second end, a curved portion, and a channel portion disposed between the second end of the second longitudinal member and the curved portion of the second longitudinal member.

[0018] For some applications, the channel region defines a channel extending laterally through the second longitudinal member.

[0019] In some applications, the second longitudinal member is positioned such that the curved portion of the second longitudinal member extends away from the second end of the second longitudinal member and the channel portion of the second longitudinal member in a loop toward the first end of the second longitudinal member, and the first end of the second longitudinal member extends from the curved portion of the second longitudinal member and through the channel of the second longitudinal member, thereby closing the loop of the second longitudinal member.

[0020] In some applications, the rod further extends laterally through a first end of a second longitudinal member of the set such that the rod prevents the first end of the second longitudinal member from sliding through the channel of the second longitudinal member.

[0021] In some applications, the system and / or device further includes an implant in a crimped state and biased to an expanded state, and the longitudinal member is positioned around the implant such that the loops are tightly fitted around the implant, thereby causing the rod to prevent the first end from sliding through the channel, thereby causing the longitudinal member to restrain the implant in the crimped state.

[0022] In some applications, the first end extends from the channel in a direction away from the curved portion, the longitudinal member defines a first opening of the channel, the first opening facing the curved portion, and a second opening of the channel, the second opening facing the first end, and the rod extends laterally through the first end between the second opening and the first end, whereby expansion of the loop is limited by the rod abutting the second opening at the channel site.

[0023] For some applications, the rod extends laterally through the channel region and the first end of the channel.

[0024] For some applications, the fastener is configured such that the loop can be opened by removing the rod from the first end and sliding the first end within the channel.

[0025] In some applications, the rod is rigid.

[0026] For some applications, the rod is flexible.

[0027] For some applications, the longitudinal members are longitudinally elastic.

[0028] For some applications, the longitudinal members include cords.

[0029] For some applications, the longitudinal member includes a polymer.

[0030] For some applications, the longitudinal members include sutures.

[0031] For some applications, the loop defines a loop plane, and the rod extends laterally through the first end in an orientation substantially perpendicular to the loop plane.

[0032] For some applications, the loop defines a loop plane and the rod extends laterally through the first end in an orientation substantially parallel to the loop plane.

[0033] In some applications, the length of the rod is greater than 1 meter.

[0034] In some applications, the rod is less than 2 cm in length.

[0035] In some applications, the rod is less than 1 cm in length.

[0036] In some applications, the rod is less than 0.5 cm in length.

[0037] For some applications, the system and / or device further includes a catheter defining a lumen transluminally advanceable towards the subject's heart, the longitudinal member being deliverable from a distal end of the catheter.

[0038] For some applications, the rod is coupled to a tether, the tether being more flexible than the rod, and the fastener is deliverable from the catheter while at least a portion of the tether extends proximally from the rod through the catheter.

[0039] For some applications, the fastener can be advanced transluminally towards the subject's heart such that the catheter bends, thereby bending at least a portion of the tether.

[0040] For some applications, the fastener can be advanced transluminally toward the subject's heart while at least a portion of the rod is disposed within the lumen of the catheter.

[0041] For some applications, the rod is flexible and the fastener is transluminally advanceable towards the subject's heart such that bending of the catheter causes at least a portion of the rod to bend.

[0042] For some applications, the system and / or device further includes a deployable member, the deployable member coupled to the loop.

[0043] For some applications, at least a portion of the deployable member extends through the loop and is dimensioned relative to the loop to prevent sliding of the deployable member relative to the loop.

[0044] For some applications, the loop fits tightly around at least a portion of the deployable member.

[0045] For some applications, the deployable member defines a plurality of struts, and at least one of the plurality of struts extends through the loop.

[0046] For some applications, the deployable member is an implant.

[0047] For some applications, the deployable member is a fluoroscopic marker.

[0048] For some applications, the deployable member is a stent.

[0049] For some applications, the deployable member is a prosthetic heart valve.

[0050] For some applications, the deployable member is self-expanding.

[0051] For some applications, the deployable member is balloon expandable.

[0052] For some applications, the fastener is configured such that the deployable member is detachable from the loop by withdrawing the rod from the first end and sliding the first end within the channel.

[0053] For some applications, the system and / or device further includes an elongate member, wherein the fastener couples the elongate member to the deployable member.

[0054] For some applications, the elongate member is secured to the curved portion of the longitudinal member.

[0055] In some applications, the elongate member is configured to extend transluminally from outside the subject to the subject's heart, such that the deployable member is positioned within the subject's heart by manipulating the proximal end of the elongate member.

[0056] For some applications, the system and / or device further includes a stopper coupled to the elongate member, the stopper being wider than the elongate member to prevent sliding of the elongate member relative to the loop.

[0057] According to some applications, there is further provided a method for use with an implant, the method including: crimping the implant; and, while the implant is being crimped, positioning the longitudinal member to form a loop around the implant such that a first end of the longitudinal member extends through a channel extending laterally through the longitudinal member at a channel site of the longitudinal member.

[0058] In some applications, the method includes restraining the implant in a crimped state by preventing expansion of the loop by piercing a rod through the first end, thereby preventing the rod from sliding the first end through the channel.

[0059] In some applications, piercing the rod through the first end includes piercing the rod laterally through the first end such that expansion of the loop is prevented by the rod abutting the longitudinal member laterally across the channel site.

[0060] For some applications, the longitudinal member is a first longitudinal member of a set of longitudinal members and the method further includes:

[0061] placing a second longitudinal member of the set in a loop around the implant;

[0062] piercing a rod through a first end of the second longitudinal member such that the rod inhibits expansion of the loop of the second longitudinal member.

[0063] For some applications, positioning the longitudinal member to form a loop around the implant includes positioning the longitudinal member to form the loop and then threading the loop over the implant.

[0064] In some applications, positioning the longitudinal member to form a loop around the implant includes forming a loop around the implant by inserting a first end into a channel site and pulling the first end away from the channel site prior to threading the rod through the first end.

[0065] In some applications, the longitudinal member is longitudinally elastic, and positioning the longitudinal member to form the loop includes elastically stretching the longitudinal member by pulling the first end away from the channel site, and piercing the rod through the first end includes piercing the rod through the first end while the longitudinal member is in the elastically stretched state.

[0066] For some applications, the method further includes releasing the first end such that elastic contraction of the longitudinal member attracts the rod against the channel site.

[0067] In some applications, a portion of the first end of the longitudinal member extends from the channel in a direction away from the channel portion and the rod extends laterally through a portion of the first end, whereby preventing expansion of the loop includes preventing expansion of the loop by the rod abutting the channel portion.

[0068] For some applications, the rod extends laterally through the channel region and the first end of the channel.

[0069] For some applications, the method further includes transluminally advancing a catheter toward the subject's heart and delivering the implant from a distal end of the catheter while the implant is crimped and restrained by the longitudinal member.

[0070] For some applications, the method further includes facilitating the expansion of the implant by facilitating the enlargement of the loop by removing the rod from the longitudinal member.

[0071] For some applications, the implant is biased into an expanded state, and facilitating the expansion of the implant includes facilitating the enlargement of the loops such that the implant self-expands.

[0072] For some applications, making the loop easier to expand includes making the loop easier to open.

[0073] In some applications, the rod is flexible, and delivering the implant from the distal end of the catheter includes delivering the implant from the distal end of the catheter such that the rod extends proximally from the longitudinal member, through the catheter, and out of the subject, and removing the rod from the longitudinal member includes removing the rod from the longitudinal member by pulling the rod proximally from outside the subject.

[0074] In some applications, the rod is coupled to a tether that is more flexible than the rod, and delivering the implant from the distal end of the catheter includes delivering the implant from the distal end of the catheter such that the tether extends proximally from the rod, through the catheter and out of the subject, and removing the rod from the longitudinal member includes removing the rod from the longitudinal member by pulling the tether proximally from outside the subject.

[0075] In some applications, delivering the implant from the distal end of the catheter further includes delivering the entire rod from the catheter, such that the tether extends into the distal end of the catheter and out of the subject.

[0076] The methods and steps described above may be performed in a live animal or in a simulation, such as a cadaver, a cadaver heart, a simulator (eg, a simulated body part, cardiac tissue), etc.

[0077] According to some applications, there is further provided a system and / or device for use with cardiac tissue of a subject, the system and / or device including a guide assembly, an implant, and a tool.

[0078] The guide assembly can include a guide frame transluminally advanceable relative to the heart and deployable at a site within the heart, one or more fasteners secured to the guide frame, each fastener defining a closed loop and locked to maintain the loop, and a guide rail threaded through the fasteners to position the guide rail along tissue upon deployment of the guide frame at the site.

[0079] The tool can be configured to position the implant along the tissue while guided by the guide rail and secure the implant to the tissue such that the implant is coupled to the guide frame by being disposed through loops of fasteners.

[0080] One or more fasteners can be unlocked within the heart, allowing the guide frame to be separated from the implant.

[0081] For some applications, the guide frame is configured to be deployed within an atrioventricular valve of the heart.

[0082] For some applications, the guide rail is held in an arc around at least a portion of the guide frame by a fastener.

[0083] For some applications, the guide rail is radiopaque.

[0084] In some applications, the system and / or device further includes a rod and each one or more of the fasteners includes a longitudinal member arranged to define a loop with an end of the longitudinal member extending through a channel extending laterally through the longitudinal member and locked by a rod extending laterally through the end to prevent the end from sliding through the channel.

[0085] In some applications, each of the one or more fasteners can be unlocked by sliding a rod off the end.

[0086] For some applications, the implant includes a helical member that is implantable along the tissue by rotation of the helical member.

[0087] In some applications, the helical member has an axial length of between 5 and 12 cm.

[0088] For some applications, the helical member has a sharp tip.

[0089] For some applications, the helical member defines a central channel, and the implant is implantable along the tissue while the guide rails extend along the central channel.

[0090] In some applications, the guide rail is configured to be axially slidable proximally through the central channel while the implant remains implanted along the tissue with the guide rail extending along the central channel.

[0091] In some applications, the system and / or device further includes a contraction member extending coaxially through a channel defined by the guide rail, the guide rail being axially slidable proximally over the contraction member (i) through the central channel and (ii) leaving the contraction member within the central channel.

[0092] For some applications, the system and / or device further includes a stopper coupled to a distal end of the contraction member, such that tension applied to the contraction member causes the helical member to contract longitudinally with the stopper preventing the contraction member from sliding through the central channel.

[0093] In some applications, the stopper is a first stopper, and the system and / or device further includes a second stopper configured to lock the tension in the contraction member by being proximally coupled from the helical member to the contraction member.

[0094] In some applications, the helical member defines a series of bends, and the implant can be implanted along the tissue by threading the helical member along a surface of the tissue such that a portion of each of the bends is embedded in the tissue and another portion of each of the bends is disposed outside the tissue.

[0095] For some applications, the guide rail is configured to limit the depth of penetration of the helical member into tissue.

[0096] For some applications, the central channel has a diameter and the guide rails have a thickness that is at least 25 percent of the diameter of the central channel.

[0097] In some applications, the thickness of the guide rail is at least 40 percent of the diameter of the central channel.

[0098] For some applications, the thickness of the guide rail is at least 50 percent of the diameter of the central channel.

[0099] For some applications, the thickness of the guide rail is at least 70 percent of the diameter of the central channel.

[0100] In some applications, the system and / or device further includes a stopper coupled to a distal end of the guide rail such that tension applied longitudinally to the guide rail causes the helical member to contract with the stopper preventing the guide rail from sliding proximally out of the central channel.

[0101] In some applications, the stopper is a first stopper, and the system and / or device further includes a second stopper configured to lock tension in the guide rail by being proximally coupled from the helical member to the guide rail.

[0102] For some applications, the tissue is heart valve annulus tissue, and the implant is configured such that contraction of the helical member causes the valve annulus tissue to contract after the implant is implanted along the tissue.

[0103] For some applications, the helical member is sufficiently flexible to follow the guide rail along the tissue.

[0104] For some applications, the helical member has a constant pitch.

[0105] According to some applications, a method for use with a subject's heart is provided that includes deploying a guide assembly at a site within the heart, the guide assembly including a guide frame and fasteners, each of the fasteners secured to the guide frame to define a closed loop.

[0106] For some applications, the guide rail is threaded through a loop to position the guide rail along the cardiac tissue to deploy the guide assembly at the site.

[0107] For some applications, the method includes implanting the implant along the tissue while being guided by the guide rail, such that the implant is secured to the tissue and disposed through the loops of the fastener.

[0108] In some applications, the method then includes opening the loop within the heart and removing the guide frame and fasteners from the heart while the implant remains implanted along the tissue.

[0109] In some applications, the site is an atrioventricular valve of the heart, the heart tissue is annulus tissue of the atrioventricular valve, and deploying the guide assembly at the site includes deploying a guide frame within the atrioventricular valve such that the guide rails are disposed along the heart valve annulus.

[0110] For some applications, the method further includes removing the guide rail from the subject after implanting the implant along the tissue by sliding the guide rail from the implant.

[0111] For some applications, at least a portion of the guide assembly is radiopaque, and retracting the tissue includes retracting the tissue while guided by at least one fluoroscopic image that includes the portion of the guide assembly.

[0112] In some applications, each of the fasteners includes a longitudinal member, the guide assembly further includes at least one rod, and deploying the guide assembly includes deploying the guide assembly while each of the longitudinal members is positioned to define a loop with an end of the longitudinal member extending through a channel extending laterally through the longitudinal member and locked by the rod extending laterally through the end, preventing the end from sliding through the channel.

[0113] In some applications, the method further includes unlocking the fastener by removing the rod from the end (i) after the implant has been secured to the tissue and disposed through the loop of the fastener, and (ii) before opening the loop.

[0114] In some applications, opening the loop includes opening the loop while the fastener remains secured to the guide frame, and removing the guide frame and fastener from the heart includes withdrawing the fastener from the heart by removing the guide frame from the heart while the fastener remains secured to the guide frame.

[0115] For some applications, the implant includes a helical member, and implanting the implant along the tissue includes threading the helical member into the tissue via rotation of the helical member.

[0116] In some applications, removing the guide frame and fasteners from the heart includes removing the guide frame and fasteners from the heart while leaving at least a portion of the guide rail coupled to a helical member within the heart.

[0117] For some applications, screwing the helical member into tissue via rotation of the helical member includes applying a torque to a proximal end of the helical member.

[0118] For some applications, threading the helical member into tissue includes threading the helical member into tissue such that a threaded axis of the helical member is disposed along a surface of the tissue.

[0119] For some applications, threading the helical member into tissue includes threading the helical member into tissue such that the helical member is at least partially embedded within the tissue.

[0120] In some applications, the helical member defines a plurality of bends, and screwing the helical member into the tissue includes screwing the helical member into the tissue such that a portion of each bend is embedded in the tissue and another portion of each bend is disposed above the tissue.

[0121] In some applications, the helical member defines a central channel, and implanting the implant along the tissue includes implanting the helical member along the tissue with the helical member threaded over the guide rail and the guide rail extending through at least a portion of the central channel.

[0122] For some applications, implanting the helical member along the tissue includes implanting the helical member along the tissue with guide rails limiting the depth to which the helical member penetrates the tissue.

[0123] For some applications, the method includes advancing a tensioning tool toward the heart after removing the guide frame and fasteners from the heart, contracting the tissue by tensioning at least a portion of the guide rails using the tensioning tool, and removing the tensioning tool from the heart, thereby maintaining the guide rails and at least a portion of the helical member implanted along the tissue.

[0124] For some applications, the method further includes locking tension in at least a portion of the guide rail by locking a stopper to the guide rail.

[0125] The methods and steps described above may be performed in a live animal or in a simulation, such as a cadaver, a cadaver heart, a simulator (eg, a simulated body part, cardiac tissue), etc.

[0126] According to some applications, there is further provided a method for use in a subject's heart, comprising transluminally advancing a catheter toward the heart, the catheter being coupled to a fastener and carrying a guide rail, and delivering the guide rail from the catheter into the heart such that the guide rail is threaded through a loop of the fastener and extends along tissue of the heart. The method also includes deploying an implant along tissue, guided from the catheter by sliding the loop along over the guide rail.

[0127] For some applications, the method includes subsequently, within the heart, decoupling the catheter from the guiderail by opening the loop.

[0128] In some applications, the cardiac tissue is annulus tissue of an atrioventricular valve of the heart, and delivering the guide rail includes delivering the guide rail from the catheter into the heart such that the guide rail is threaded through a loop of the fastener and extends along the annulus tissue.

[0129] In some applications, the method further includes transluminally advancing a tensioning tool toward the implant after disconnecting the catheter from the guide rail, then tensioning at least a portion of the implant using the tensioning tool, and then removing the tensioning tool from the subject.

[0130] In some applications, the guide rail comprises a radiopaque material and tensioning using the tensioning tool includes tensioning using the tensioning tool while aided by at least one fluoroscopic image that includes the guide rail.

[0131] In some applications, the guide rail comprises a radiopaque material, and deploying the implant along the tissue comprises deploying the implant along the tissue while further guided by at least one fluoroscopic image that includes the guide rail.

[0132] For some applications, the method further includes removing the catheter from the subject prior to advancing the tensioning tool.

[0133] In some applications, advancing the catheter toward the heart includes advancing the catheter within the sheath toward the heart, removing the catheter from the heart includes removing the catheter from the subject through the sheath, and advancing the tensioning tool includes advancing the tensioning tool through the sheath toward the heart.

[0134] For some applications, the implant includes a contraction member, and tensioning at least a portion of the implant includes tensioning the contraction member.

[0135] For some applications, the implant further includes a first tissue anchor and a second tissue anchor, and tensioning the contraction member includes tensioning the contraction member such that a distance between the first tissue anchor and the second tissue anchor is decreased.

[0136] For some applications, at least a second tissue anchor is slidably coupled to the contraction member, and tensioning the contraction member includes sliding the contraction member relative to the at least second tissue anchor.

[0137] For some applications, deploying the implant includes deploying the implant to pass the first tissue anchor and the second tissue anchor through the contraction member.

[0138] In some applications, the guide rails are defined by a guide frame, and delivering the guide rails includes deploying the guide frame within the heart such that the guide rails complement a shape of the tissue.

[0139] In some applications, the guide frame includes one or more struts that protrude away from a plane defined by the guide frame, and deploying the guide frame within the heart includes delivering the guide frame within the heart such that each of the one or more struts protrudes away from the guide frame and extends through a respective commissure of an atrioventricular valve of the heart.

[0140] The methods and steps described above may be performed in a live animal or in a simulation, such as a cadaver, a cadaver heart, a simulator (eg, a simulated body part, cardiac tissue), etc.

[0141] According to some applications, there is further provided a system and / or device for use in tissue of a subject, the system and / or device including a guide rail, an implant, and an implantation assembly. The implantation assembly can include a fastener at a distal end portion thereof defining a loop, the implantation assembly configured to transluminally position the guide rail along the tissue of the subject with the loop threaded over the guide rail.

[0142] In some applications, the implant assembly is also configured to implant the implant transluminally along tissue while being guided along the guide rail by passing the loop over the guide rail, and to detach intracorporeally from the guide rail by releasing the loop, thereby allowing the implant assembly to be removed from the subject independent of the guide rail.

[0143] For some applications, the implant assembly can be advanced transluminally towards the subject's tissue with the fastener loops threaded through the guide rails.

[0144] For some applications, the guide rail includes a radiopaque material.

[0145] In some applications, the fastener includes a longitudinal member positioned to define a loop with a first end of the longitudinal member extending through a channel extending laterally through the longitudinal member at a channel site of the longitudinal member, and a rod extending laterally through the first end and preventing opening of the loop by preventing the first end from sliding through the channel.

[0146] For some applications, the rod can be removed from the longitudinal member, and once the rod is removed from the longitudinal member, the loop can be opened by sliding the first end within the channel.

[0147] In some applications, the guide rail is compressible for transluminal delivery to tissue and expandable within the body for positioning along the tissue.

[0148] In some applications, the guide rail has a predetermined expanded shape that complements the shape of tissue, is compressible from the predetermined expanded shape to a compressed shape for transluminal delivery to tissue, and is expandable in vivo from the compressed shape to the predetermined expanded shape.

[0149] For some applications, the tissue includes tissue of a native heart valve annulus.

[0150] In some applications, the guide rail is shaped to define: (1) a base frame having a shape that tracks the circumference of the native heart valve annulus; and (2) one or more struts that protrude away from a plane defined by the base frame and provide indicators of one or more commissures of the native heart valve.

[0151] For some applications, the implant includes at least one tissue anchor.

[0152] For some applications, the implant includes at least two tissue anchors.

[0153] For some applications, the implant further includes a contraction member slidably coupled to the at least two tissue anchors.

[0154] For some applications, at least two tissue anchors are threaded over the contraction member.

[0155] For some applications, the system and / or apparatus further includes a tensioning tool adapted to apply a tensioning force to the contraction member.

[0156] Further, according to some applications, there is provided a method for use in a subject's heart, comprising transluminally advancing an implant coupled to a fastener toward the heart, the fastener comprising a longitudinal member arranged in a loop such that a first end of the longitudinal member extends through a channel extending laterally through the longitudinal member at a channel site of the longitudinal member, and a rod extending laterally through the first end and preventing the first end from sliding through the channel.

[0157] For some applications, the method includes delivering the implant from the catheter into the heart while the implant is coupled to the fastener, and then removing the rod from the first end.

[0158] For some applications, transluminally advancing an implant coupled to the fastener toward the heart includes transluminally advancing at least a portion of the implant extending through a loop of the fastener toward the heart.

[0159] In some applications, transluminally advancing the implant coupled to the fastener toward the heart includes transluminally advancing the implant coupled to the elongate member by the fastener toward the heart to position the implant within the heart, and using the elongate member to position the implant within the heart before removing the rod from the first end.

[0160] In some applications, removing the rod from the first end includes removing the rod from the first end such that the implant is released from the loop and the fastener remains coupled to the elongate member.

[0161] The methods and steps described above may be performed in a live animal or in a simulation, such as a cadaver, a cadaver heart, a simulator (eg, a simulated body part, cardiac tissue), etc.

[0162] A further understanding of the nature and advantages of the present invention can be found in the following description and claims, particularly when considered in conjunction with the accompanying drawings in which like parts bear like reference numerals and in which: [Brief description of the drawings]

[0163] [Figure 1] FIG. 1 is a schematic diagram of a fastener and its variations, according to some applications. [Diagram 2] FIG. 2 is a schematic diagram of a fastener and its variations, according to some applications. [Diagram 3] FIG. 3 is a schematic diagram of a fastener and its variations, according to some applications. [Figure 4] FIG. 4 is a schematic diagram of a fastener and its variations, according to some applications. [Diagram 5] FIG. 5 is a schematic diagram of a system and technique for using fasteners as components of a system for positioning an implant, according to a respective application. [Figure 6]FIG. 6 is a schematic diagram of a system and technique for using fasteners as components of a system for positioning an implant, according to a respective application. [Figure 7] FIG. 7 is a schematic diagram of a system and technique for using fasteners as components of a system for positioning an implant, according to a respective application. [Figure 8] 8A-8C are schematic diagrams of systems and techniques for placing fasteners, according to some applications. [Figure 9] 9A-9I are schematic diagrams of systems and techniques using multiple fasteners within a system to guide implantation of an implant, according to respective applications. [Figure 10] FIG. 10 is a schematic diagram of a system and technique for using multiple fasteners within a system to guide implantation of an implant, according to a respective application. [Figure 11] FIG. 11 is a schematic diagram of a system and technique for using fasteners as components of a system for guiding implantation of an implant according to a respective application. [Figure 12] 12A-12G are schematic diagrams of systems and techniques using fasteners as components of a system for guiding implantation of an implant, according to respective applications. [Figure 13] 13A-13B are schematic diagrams of a fastener and its variations according to several applications. [Figure 14] FIG. 14 is a schematic diagram of a fastener and its variations according to some applications. [Figure 15] FIG. 15 is a schematic diagram of a fastener and its variations according to some applications. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0164] Please refer to FIGS. 1-5, 13A-13B, and 14, which are schematic illustrations of examples of fasteners 40 (e.g., variations 40a, 40b, 40c, and 40d thereof) and techniques for use therewith, according to some applications. Fasteners 40 include longitudinal members 20 arranged in loops 28. FIG. 1 illustrates longitudinal members 20 and includes an inset showing that the longitudinal members can include a braided material, such as a cord. However, it should be noted that in some applications, the longitudinal members may include different materials and / or have different structures. For example, longitudinal members 20 may include one or more of strings, ribbons, polymers, proteins, and metals. The longitudinal members 20 may include sutures.

[0165] The longitudinal member 20 has a first end 20a comprising a first end 21 of the longitudinal member, a second end 20c comprising a second end 22 of the longitudinal member, and a curved portion 20b between the first end and the second end. Between the first end 21 and the second end 22, the longitudinal member 20 has a channel region 26 in which the longitudinal member defines a channel 24 extending laterally through the longitudinal member. That is, the channel 24 extends laterally through the body of the longitudinal member 20 at the channel region 26. In some applications in which the longitudinal member 20 comprises a braided material, the longitudinal member may be threaded between the strands of the braid, that is, the channel 24 is defined between the strands of the braid.

[0166] The longitudinal member 20 has a thickness of at least 0.1 mm (e.g., at least 0.2 mm, e.g., at least 0.3 mm) and / or 1 mm or less (e.g., 0.5 mm or less, e.g., 0.4 mm or less, e.g., 0.3 mm or less). For example, the longitudinal member 20 may have a thickness of 0.2-0.4 mm. In some applications, the longitudinal member 20 may be a suture having a USP designation 2-0, 3-0, or 4-0.

[0167] A loop 28 is formed by the first end 20a being threaded through the channel 24. In the resulting configuration of the longitudinal member 20, the curved portion 20b extends away from the first end 20a and the channel 24, and back toward the channel section 26. Figure 4 shows an example where this can be accomplished by looping a curved portion of the thread 80 around the first end 20a with the two free ends of the thread disposed on the other side of the channel 24 (i.e., so that two lengths of the thread extend through the channel), and then pulling the first end 20a through the channel by pulling the ends of the thread.

[0168] To prevent the loop 28 from expanding and / or opening (e.g., to maintain the longitudinal member within the loop), the rod 30 extends laterally through the first end 20a, thereby preventing (e.g., preventing) the first end from sliding within the channel 24 (i.e., from sliding within the channel in a direction that would expand and / or open the loop). That is, the presence of the rod 30 through the first end 20a locks the fastener 40. The rod 30 may be long and flexible enough for transluminal use (e.g., as described below), but may be sufficiently rigid not to bend and slide within the channel 24. For example, the rod 30 may include a wire (e.g., including a metal such as Nitinol or stainless steel, and / or including a polymer). However, it should be noted that in some applications, the rod may include a different material and / or have a different structure. In some applications, the end of the rod defines a sharp piercing tip for piercing the first end 20a. In some such applications, the piercing tip comprises a rigid, inflexible material.

[0169] The rod 30 may have a thickness greater than 0.01 mm and / or less than 1 mm (eg, 0.05 to 0.5 mm, eg, 0.05 to 0.2 mm, eg, 0.1 mm).

[0170] The rod 30 may have a length of more than 0.1 cm (eg, 0.1-2 cm, eg, 0.1-1 cm, eg, 0.2-0.5 cm, eg, 0.5 cm) and / or less than 2 m (eg, 1-2 m, eg, 1.5 m).

[0171] Thus, it is hypothesized that the small size of fastener 40 is advantageous for its use in percutaneous (e.g., transluminal) techniques, such as (but not limited to) those described below. Additionally, the simplicity of fastener 40, including the lack of catches, tabs, detents, or other projection-like components, and the lack of complex machine-like mechanisms, is advantageous in that it increases the reliability of the fastener, especially when it is under high forces (e.g., stress) when it is required to be released. For example, it is hypothesized that fastener 40 remains reliably unlockable even when longitudinal member 20 is under substantial tension, as rod 30 remains reliably slidable out of channel 24.

[0172] 1-2 illustrate a variation of fastener 40, fastener 40a, in which rod 30 extends laterally through a portion of first end 20a extending from channel portion 24 of the channel, such that pulling the first end toward channel portion 26 and curved portion 20b pulls the rod toward the opening of the channel, causing the rod to lie against the opening and effectively block the rod, thereby preventing the first end from sliding within the channel and expanding loop 28. In some applications, to maximize the inhibition of sliding of first end 20a through channel 24, rod 30 extends through first end proximate channel portion 26.

[0173] FIG. 3 shows a variation of fastener 40, fastener 40b, in which rod 30 extends laterally through a portion of first end 20a disposed within channel 24, such that the rod prevents expansion of loop 28 by anchoring a portion of the first end to the wall of the channel.

[0174] The loop 28 can be considered to lie on (e.g., define) the loop plane. In some applications, the rod 30 extends laterally through the first end 20a in an orientation that is substantially parallel to or coincident with the loop plane (e.g., as shown in FIGS. 1-2). In some applications, the rod 30 extends laterally through the first end 20a in an orientation that is substantially perpendicular to the loop plane (e.g., as shown in FIG. 3).

[0175] The loop 28 can be released by removing the rod 30 from the first end 20a, allowing the first end to slide within the channel 24, expanding and / or opening the loop. In some applications, the rod 30 is long and flexible, allowing it to be delivered transluminally in a catheter (e.g., internally) through the subject's vasculature toward the heart. Thus, the fastener 40 can be released by removing the rod from the longitudinal member by pulling the rod proximally from outside the subject.

[0176] 13A-13B and 14 respectively show fasteners 40c and 40d, which are variations of fastener 40. In contrast to the example described above in which rod 30 extends through first end 20a only at a single location, FIGS. 13A-14 show an example in which the rod extends through the first end at both first location 33' and second location 33", thereby securing the first end within secondary loop 29. Secondary loop 29 can be disposed between the first and second locations.

[0177] First portion 33' is disposed on first portion 20a' of first end 20a, and second portion 33" is disposed on second portion 20a" of first end 20a. First portion 20a' extends from primary loop 28 and channel toward secondary loop 29. Second portion 20a" extends from secondary loop 29 back toward channel 24 and first end 21. In some applications, fasteners 40c and / or 40d can be formed by first forming secondary loop 29 and then pushing the secondary loop through channel 24.

[0178] Fasteners 40c and 40d are configured such that when rod 30 is retracted proximally a first distance, the rod exits first portion 33' but not second portion 33'', thereby allowing the first portion to slide through channel 24, but not the second portion. It is hypothesized that this may advantageously allow for pre-expansion of loop 28 without fully opening the loop (i.e., without fully releasing the fastener). This is shown in the transition between FIGS. 13A and 13B, which shows loop 28 expanding slightly as the rod is retracted from the first portion, with first portion 33' sliding through channel 24. In applications where fastener 40c is used with an implant (e.g., as described below), it is hypothesized that this may provide the operator with an opportunity to withdraw rod from first portion 33' and allow loop 28 to expand (e.g., relax) slightly, and then decide whether to complete implantation of the implant. If implantation is determined to be suboptimal, fastener 40c can allow for repositioning and / or retrieval of the implant as the loop remains closed as rod 30 remains extending through second portion 33".

[0179] In some applications, the force applied by the rod 30 to the first portion 20a can be reduced by the secondary loop 29 and / or by the rod extending through the first portion at two locations. For example, a force that may pull the first end toward the channel 24 may be more widely distributed across the first end. Similarly, the presence of the rod 30 at the second location 33'' can reduce the likelihood that the first end will fray in response to the rod being pressed against the first portion 33' because the rod will resist such a force pulling the first portion through the channel 24. This can further advantageously allow less excess length of the first end 20a to be required to prevent this undesired fraying.

[0180] In fastener 40c, second portion 20a'' extends rearwardly through channel 24 toward first end 21.

[0181] In fastener 40d, second portion 20a" does not extend rearwardly through the channel, resulting in a longitudinal member with only first portion 20a' extending through the channel. In such an embodiment, it is assumed that removal of rod 30 from only first portion 33' results in an intermediate configuration similar to that shown in fastener 40a, with rod 30 only extending through first portion 20a in a single location.

[0182] Reference is now made to Figure 15, which illustrates a fastener 40e, according to some applications. Fastener 40e may be considered a variation of fastener 40.

[0183] Fastener 40e includes a longitudinal member 20' which may be identical to longitudinal member 20 described above, except that longitudinal member 20' may not define a channel therethrough and is not threaded therethrough. Rather, first portion 20a is formed into a secondary loop 29 by the first portion looping around second portion 20c. Similar to fasteners 40c and 40d, secondary loop 29 is secured by rod 30 extending through first portion 20a at first location 33' and second location 33'', with the secondary loop being between the first and second locations.

[0184] Also similar to fasteners 40c and 40d, first portion 33' is disposed on first portion 20a' of first end 20a, and second portion 33" is disposed on second portion 20a" of first end 20a. First portion 20a' extends from primary loop 28 toward secondary loop 29. Second portion 20a' extends from secondary loop 29 rearward toward first end 21. Note that first portion 20a', second portion 20a", and rod 30 collectively define a closed loop around second portion 20c. That is, secondary loop 29 and rod 30 collectively define a closed loop around second portion 20c.

[0185] It is hypothesized that in some applications, the arrangement shown as fastener 40e may advantageously eliminate the requirement for a channel defined through the longitudinal member. It is further hypothesized that in some applications, this arrangement may provide benefits similar to those described for fasteners 40c and 40d, such as the ability to slightly enlarge the primary loop by withdrawing the rod from the first portion without releasing the fastener.

[0186] In some applications, a single rod 30 can be used to lock the multiple fasteners (e.g., preventing the multiple loops 28 from expanding and / or opening) by extending through the first end 20a of the loops. FIG. 5 illustrates such an application, showing multiple fasteners 40 used to constrain an implant 60, such as a prosthetic heart valve or stent, in a crimped state. In some applications, the implant 60 may be biased to an expanded state (i.e., self-expanding), whereby the loops 28 constrain the self-expansion of the implant. The implant is optionally transluminally deliverable via a catheter 52 while being constrained in its crimped state by the fasteners. In some applications, prior to constraining the implant 60 with the fasteners 40, the implant 60 is tightly crimped, and then the loops 28 are placed around the crimped implant. In some applications, the fasteners 40 may be preassembled and threaded over the implant with the loops 28 crimped.

[0187] It should be noted that the implant 60 may initially expand slightly until it is forced against the loop 28, but the state constrained by the fastener 40 may still be considered its crimped state. Once the implant 60 is positioned within the heart (e.g., delivered from the distal end of the catheter 52), the rod 30 may be removed from the loop 28. Once the implant 60 is free from the constraints of the loop, it may be biased to an expanded state, which allows the implant to self-expand within the heart. That is, removal of the rod 30 from the first end 20a may facilitate (e.g., trigger) the loop to expand and / or open, which allows the implant to self-expand and thus deploy within the heart. Despite the expansion force exerted by the implant 60 on the loop 28, it is assumed that the rod 30 remains slidable out of the channel 24 without undue pulling on the rod, which may inadvertently displace the implant 60.

[0188] For some applications, the implant 60 may be balloon expandable.

[0189] As discussed above, rod 30 may be sufficiently long and flexible for transluminal use. For example, during transcatheter use of fastener 40 (e.g., when a catheter such as catheter 52 is used to deliver an implant such as implant 60), the fastener can be advanced transluminally toward the heart while at least a portion of the rod is disposed within the lumen of the catheter. For example, rod 30 can be easily bent in response to bending of the catheter through which it extends.

[0190] It should be noted that in some applications, an arrangement of multiple longitudinal members 20 restrained (e.g., locked) by a single rod 30 as a loop 28, such as the arrangement shown in FIG. 5, may optionally be considered to be a single fastener including multiple longitudinal members and a single rod.

[0191] The connector 42 can be used to connect the longitudinal member 20 so that once the implant 60 has been deployed within the heart by removing the rod 30, the longitudinal member can be retracted from the heart by removing the connector through the catheter and from the subject.

[0192] 6 and 7, which are schematic illustrations of an application in which an implant 60 may be positioned within a heart using a positioning tool 90 (e.g., including an elongated member such as a shaft) that is coupled to the implant using at least one fastener 40. It should be noted that another deployable member may be substituted for implant 60, with appropriate modifications.

[0193] The positioning tool 90 may be long and at least partially flexible so that once the implant is positioned within the heart, the positioning tool can extend from the portion of the heart that is coupled to the implant, through the vasculature, and proximally from the subject, so that the positioning tool, and thus the implant, can be manipulated by adjusting the positioning tool outside the body.

[0194] Coupling of the positioning tool 90 and the implant 60 by the fastener 40 can be accomplished by the fastener being secured to the positioning tool and the loop 28 being threaded over / around at least a portion of the implant 60. For some applications, and as illustrated, the implant 60 includes a number of struts that are disposed within a cellular structure, for example. For some such applications, and as illustrated, the loop 28 is threaded around the struts of the implant 60 (e.g., through one or more cells of the implant's cellular structure), thereby securely coupling the positioning tool 90 to the implant.

[0195] In some applications, the positioning tool 90 is secured to the longitudinal member 20 such that once the fastener is released (i.e., by removing the rod 30), the longitudinal member remains secured to the positioning tool. For example, the fixation element 95 secured to the positioning tool 90 may extend through the loop 28 (e.g., as shown in FIG. 6) or through a transverse hole in the curved portion 20b or the second end 20c of the longitudinal member 20 (e.g., as shown in FIG. 7). Examples of how the fixation element 95 can be secured to the positioning tool 90 include a closed loop defined by the fixation element and extending around the positioning tool (e.g., as shown in FIG. 7) and / or through a passageway defined through the positioning tool (e.g., as shown in FIG. 6). The fixation element can be configured in a variety of ways, such as, for example, a suture, a line, a wire, a clip, a fastener, etc.

[0196] For some applications, the stopper 98 is coupled to and is at least wider than the distal end of the tool 90. The stopper 98 prevents the loop 28 from sliding relative to the tool 90 (e.g., distally away).

[0197] The implant 60 can be positioned and repositioned using the tool 90, for example, before and / or after deployment of the implant at the implantation site. Once the desired position is achieved, the implant positioning tool 90 can be disengaged from the tool by retracting the rod 30, thereby allowing the loop 28 to open. It is hypothesized that ease of sliding the rod 30 out of the channel 24, mutatis mutandis, as described elsewhere herein, facilitates opening of the fastener 40 without inadvertently displacing the implant 60.

[0198] As discussed above, the rod 30 may be long and flexible enough to extend transluminally into the subject's heart. However, in some applications, the rod 30 may be short (e.g., 1-10 mm long, e.g., 2-8 mm long, e.g., 2-5 mm long) and attached to a tether 32 that may extend from the rod in the heart transluminally out of the subject (e.g., as shown in FIG. 7). For example, during transcatheter use of the fastener 40, the fastener may be delivered from the catheter while at least a portion of the tether extends proximally from the rod through the catheter, e.g., thereby allowing the rod 30 to be removed from the longitudinal member 20 by pulling the tether proximally from outside the subject. The tether 32 may be more flexible than the rod 30 (e.g., the rod may be stiff), and this flexibility may facilitate more smooth transcatheter techniques. For example, the tether may be easily bent in response to bending of the catheter extending therethrough. It should be understood that although the use of tether 32 is shown only in FIG. 7, this may be mutatis mutandis applied to the other applications described herein.

[0199] 8A-8C, which are schematic diagrams illustrating an application in which the longitudinal member 20 is longitudinally elastic, according to some applications. In some applications, it is desirable to position the fastener 40 so that the loop 28 is tight against the component therein (e.g., implant 60) to tightly grip the component, e.g., so that the component does not slide relative to the loop. It is hypothesized that such tightness is achieved by configuring the longitudinal member 20 to be elastic. In some such applications, the first end 20a is pulled through and away from the channel 24 to an extent sufficient to stretch the longitudinal member 20 (FIG. 8A). The rod 30 is then inserted through the first end 20a, often adjacent the channel 24 (FIG. 8B). The first end 20a is then released, which causes the elastic contraction of the longitudinal member to pull the rod 30 toward the channel site 26 and the loop 28 to clamp the implant (FIG. 8C).

[0200] Reference is now made to Figures 9A-9I, which are schematic diagrams illustrating the use of fastener 40 as a component of a system 155, according to some applications. System 155 includes guide assembly 100 and implant 160, and may be for use with an atrioventricular valve of a subject's heart.

[0201] The guide assembly 100 includes a guide rail 102 for guiding implantation of an implant 160 along the anatomy of a heart valve, such as an annulus 10 of a heart valve (eg, as part of an annuloplasty procedure), according to some applications.

[0202] The guide assembly 100 also often includes a guide frame 110 that is expandable (e.g., self-expanding or balloon-expandable) within the subject's heart. In some applications, and as shown, the guide frame 110 is expanded within an atrioventricular valve, e.g., the atrioventricular valve to be treated. The expansion of the guide frame pushes at least a portion of the leaflets AL and PL radially outward, often forcing the guide frame against tissue of the valve annulus (e.g., pushing the leaflets AL and PL downward and away from the annulus). Nevertheless, the valve often remains at least partially functional, e.g., because the guide frame 110 opens and allows blood to flow therethrough, and / or because the leaflets AL and PL remain partially functional (e.g., downstream of the guide frame) to provide the ultimate unidirectional flow of blood through the valve.

[0203] The plurality of fasteners 40 constrain the longitudinal members of the fasteners to the loops 28 (e.g., by the rods 30 extending through the first end 20a) and the guide rails 102 are secured along a portion of the circumference of the guide frame 110, e.g., the guide rails extend circumferentially around at least a portion of the guide frame. Positioning the guide frame 110 within the valve thus positions the guide rails 102 along the tissue of the valve annulus (e.g., in contact with or slightly upstream of the atrial surface of the valve annulus). As described below, the guide rails 102 serve as a guide for implantation of the implant 160, e.g., at least partially defining the shape that the implant 160 will assume upon its implantation.

[0204] The guide assembly 100 can be advanced transluminally (e.g., transfemorally) through the catheter 50 while the guide frame 110 is in a contracted state, and once deployed from the distal end of the catheter, the guide frame 110 expands within the heart ( FIG. 9A ) and positions the guide rails 102 along the tissue of the valve annulus 10 ( FIG. 9B ). In some applications, and as shown, the guide rails 102 extend further from the guide frame 110 proximally away from the heart. In some applications, the rods 30 also extend proximally away from the guide frame 110 and the heart (e.g., the rods extend through the catheter 50 and proximally away from the subject, allowing the rods to be removed from the fasteners 40 while the fasteners are disposed within the heart).

[0205] For some applications, the implant 160 includes a helical member 165 that defines a helix that extends around a central channel 166 defined by the helix. For some applications, the helical member is adapted to be secured within tissue (e.g., valve annulus 10) via rotation (i.e., screwed into tissue). For some applications, the helical member 165 has a sharpened tip 167 adapted to facilitate securing the helical member relative to tissue. The helical member 165 may be flexible enough to be advanced transluminally to the heart and to follow the guide rail 102. However, the helical member 165 may often be stiff enough to be screwed into tissue by applying a torque to the proximal end of the helical member. For example, the helical member 165 may generally exhibit bending flexibility (i.e., its central longitudinal axis may be easily deflected), but may not generally exhibit torsional flexibility (e.g., the helix may not be easily untwisted (i.e., uncoiled) or twisted further). In some applications, in its rest state, the helical member 165 has an axial length (i.e., length along its central axis, as opposed to a helical length along its helical shape) of 2-20 cm (e.g., 2-12 cm, e.g., 3-12 cm, e.g., 5-12 cm).

[0206] For some applications, the helical member 165 is configured to have a constant pitch along its length and / or to have a generally constant pitch during fixation in tissue. Nevertheless, for some applications, and as described below, the helical member 165 can contract axially (i.e., reduce its pitch) after being fixed in tissue.

[0207] In some applications, once the guide assembly 100 is in place, the helical member 165 is advanced from the catheter 50 and along the guide rail 102, for example, with the guide rail threaded through the central channel 166 (FIGS. 9C-9E). The implant 160 is implanted along the tissue, guided by the guide rail 102, which directs the implantation of the implant along the tissue. That is, the guide rail 102 extends along the tissue to provide a trajectory along which the implant will travel. The guide rail 102 can thereby define the shape that the implant 160 will take upon implantation. As shown, the guide rail 102 can arc around at least a portion of the guide frame 110, and the helical member 165 can be secured in an arc around at least a portion of the valve annulus.

[0208] In some applications, the guide rails 102 can extend along the tissue (e.g., the valve annulus 10) in a manner that complements (e.g., generally conforms to) the shape of the tissue. In some such applications, this can be readily accomplished by the guide frame 110 being sufficiently flexible so that its expanded shape is dictated by the existing shape of the tissue.

[0209] The helical member 165 can be implanted along the tissue such that it is at least partially threaded into the tissue. For example, the anchor driver 56 can be coupled to a proximal portion of the helical member 165, and the helical member can be threaded into the tissue by rotating the helical member. The guide rail 102 often orients the helical member 165 such that a portion of each turn is embedded in the tissue of the valve annulus 10 and another portion of each turn is disposed outside the tissue (e.g., atrium 12). In some applications, the threaded axis of the helical member 165 is disposed along the surface of the tissue. In some applications, the threaded axis can be parallel to the surface of the tissue but within the tissue (e.g., the helical member is deep within the tissue) or parallel to the surface of the tissue but within the atrium (e.g., the helical member is shallower within the tissue). 9C-9E diagrammatically illustrate an application in which the implant is partially embedded within tissue during implantation, such that a portion of each turn of the helical member sinks into the tissue and a portion of each turn remains above the tissue.

[0210] In some applications, after anchoring the helical member 165 along the tissue, at least a portion of the guide assembly 100 is removed from the heart, often via the catheter 50. For example, and as shown, the guide frame 110 can be removed with the fasteners 40 still attached.

[0211] In some applications, during implantation, the guide frame 110 is coupled to the tissue of the valve annulus 10 via the implant 160, and in order to remove the guide frame from the subject, it is necessary to detach the guide frame from the implant. For example, and as described below with reference to Figures 9H-9I, in some applications, the distal portion of the guide rail 102 additionally functions as (e.g., is) the contraction member 122 of the implant 160, e.g., at least the distal portion of the guide rail can reside within the heart as a component of the implant. In some such applications, the helical member 165 secures the guide rail 102 to the tissue to facilitate removal of the guide frame 110 from the heart independent of the guide rail, and the fasteners 40 are released, thereby releasing the guide frame from the guide rail. This can be accomplished by removing the rod 30 from the longitudinal member 20 (FIG. 9F), thereby allowing the fastener 40 to open (e.g., as shown diagrammatically by the transition between the insets of FIGS. 9F and 9G), for example, in response to being pulled away from the guide rail by the guide frame 110. In FIG. 9F, the reference numeral 40 is shown in parentheses because the longitudinal member 20 is no longer constrained by the rod 30 and thus no longer functions as a fastener.

[0212] It is hypothesized that the release of the fastener 40 described above can also advantageously release the fastener (and thus the guide frame 110 coupled thereto) when the helical member 165 is threaded through one or more loops 28 of the fastener during threading of the helical member along tissue.

[0213] In some applications, once the helical member 165 is secured along the tissue, adjustment (e.g., contraction) of the valve annulus is accomplished by tensioning the guide rail 102, causing a distal portion of the guide rail to function (e.g., become the contraction member 122 of the implant 160) (FIG. 9H). For example, a first stopper 104a secured at least in part to the distal end of the guide rail 102 prevents the distal end of the guide rail from sliding proximally through the helical member 165, and tension in the guide rail 102 (i.e., the contraction member 122) causes the helical member to contract longitudinally. To facilitate tensioning, a tensioning tool 120 delivered from the catheter 50 can be used.

[0214] Once tensioned, the tension is locked by attaching a second stop 104b to the guide rail 102, often proximally from the helical member 165, such that, for example, the contraction member 122 is defined as a portion of the guide rail 102 disposed between the first stop 104a and the second stop 104b. The stop 104b can be applied by the tool 120. In some applications, tension is applied by pulling on the guide rail 102 while simultaneously applying an opposing force, for example, by pushing the second stop 104b distally via the tensioning tool 120. FIG. 9I shows the implant 160 implanted along the valve annulus 10 once tension has been applied to the guide rail 102 (i.e., the contraction member 122).

[0215] Although Figures 9A-9I show guide assembly 100 being used in a subject's heart, for example to guide an annuloplasty procedure, it should be noted that the guide assembly may be used with any tissue and for other medical procedures.

[0216] In some applications, after the helical member is at least partially implanted along the tissue, the guide rail is removed from the subject. For example, the guide rail may not have a fixed stop at its distal end and may be pulled proximally through a central channel of the helical member. Thus, in such applications, the guide rail is not (e.g., does not become) a component of the implant.

[0217] Reference is now made to FIG. 10, which is a schematic diagram of a system 180 for use with a valve in a subject's heart, according to some applications. System 180 may be identical to system 155, unless otherwise noted. System 180, according to some applications, includes a guide assembly 182 that includes guide rails 184 for guiding implantation of helical member 165 along the annulus 10 of a native heart valve (e.g., as part of an annuloplasty procedure). Guide assembly 182 also often includes a guide frame, such as guide frame 110.

[0218] Similar to guide rail 102 described herein, guide rail 184 serves to guide fixation of helical member 165, but guide rail 184 may be thicker and stiffer than guide rail 102. Additionally, guide rail 184 often does not have a fixed stop at its distal end, and may be configured to be pulled proximally through central channel 166 of helical member 165 after the helical member has been at least partially implanted along tissue.

[0219] The additional thickness of the guide rail 184 can, for example, limit the depth to which the helical member 165 can penetrate into tissue with the guide rail abutting the surface of the tissue. For example, the guide rail 184 can have a thickness (i.e., the inner diameter of the helical member) that is at least 25% (e.g., at least 40%, e.g., at least 50%, e.g., at least 70%) of the diameter of the central channel 166 of the helical member 165. To facilitate the penetration of the helical member 165 into tissue and / or the withdrawal of the guide rail 184 from the helical member, the thickness of the guide rail can be 95% or less (e.g., 90% or less, e.g., 80% or less, e.g., 70% or less) of the diameter of the central channel 166.

[0220] As mentioned above, the guide rail 184 can be configured to be removed after the helical member 165 is secured. Thus, the guide rail 184 does not function (e.g., cannot function) as a contraction member. In some applications, a separate contraction member (e.g., a contraction wire) 186 is provided that extends through the central channel 166 of the helical member 165, e.g., coaxially with the guide rail 184 (such as through a lumen defined by the guide rail, as shown) or along the guide rail, and remains in place after the guide rail is removed. In some applications, the contraction member can be introduced after the helical member 165 is implanted. In some applications, a separate contraction member is not used, e.g., the helical member 165 itself adjusts the tissue.

[0221] Reference is now made to Figures 11 and 12A-12G, which are schematic illustrations of the use of fastener 40 as a component of system 200, according to some applications. System 200 includes an implant 264, a guide rail 242, and an implantation assembly 250 configured to implant the implant guided by the guide rail.

[0222] The system 200 often includes a base frame 240 adapted to fit over the valve annulus 10, with a portion of the base frame defining a guide rail 242 and extending along the upstream side of the annulus 10, where the implant 264 is implanted. For example, and as shown, the base frame 240 may define a ring (which may be circular or non-circular), a portion of which defines the guide rail 242. As illustrated generally in FIG. 11, the base frame 240 can define one or more (e.g., two or three) struts 246 (e.g., strut 246a and strut 246b) that project away from a plane defined by the base frame and are configured to extend downstream through respective commissures of the valve. The struts 246 support and / or stabilize the base frame 240 with the valve. Thus, positioning the base frame 240 on the valve positions the guide rails 242 along the tissue of the valve annulus (e.g., in contact with or slightly upstream of the atrial surface of the valve annulus). As described herein below, the guide rails 242 act as guides for implantation of the implant 264, e.g., at least in part, define the shape that the implant 264 will assume upon its implantation.

[0223] The base frame 240 (eg, its guide rails 242) may further provide fluoroscopic indicators of the anatomy to further facilitate guided implantation of the implant 264.

[0224] The implantation assembly 250 includes a tool 280 (e.g., including a catheter, shaft, and / or driver) adapted to be advanced transluminally (e.g., transfemorally) into the subject's heart, often within a sheath 270. The tool 280 can define an inner lumen, and the implant 264 is deliverable through the inner lumen and from a distal end of the tool. The base frame 240 can be coupled to a distal end portion of the tool 280 via fasteners 40 and remains there once the base frame 240 is deployed to the valve. The tool 280 can be long and at least partially flexible, allowing the tool to extend proximally from the base frame through the vasculature and out of the subject while the base frame 240 is disposed on the valve.

[0225] 12A illustrates a delivery state of the implant assembly 250, where the implant assembly is transluminally deliverable toward the heart within the sheath 270 while the base frame 240 is coupled to the tool 280. In the delivery state, the base frame 240 can be compressed within the sheath 270. For some applications, and as illustrated, the fasteners 40 are disposed (e.g., coupled) laterally from an outer surface of the distal end portion of the tool 280. In some applications, the rods 30 are disposed laterally from the distal end portion of the tool 280, for example, by extending from a lateral opening 282 of the tool. For example, the rods 30 can extend along the tool 280 into a secondary lumen of the tool and exit the secondary lumen at the opening 282.

[0226] The base frame 240 can be configured, upon deployment, to automatically expand towards a predetermined expanded shape that complements the shape of the tissue.

[0227] For some applications, implant 264 comprises a plurality of tissue anchors 260a-260g adapted to be secured to tissue of valve annulus 10 (e.g., such that the anchor / screw axes of the tissue anchors are substantially perpendicular to the surface of the tissue). Tissue anchors 260a-260g can be connected to one another via a contraction member (e.g., tether) 262 that can be slidably coupled to the tissue anchors (e.g., by being threaded through holes defined by the head of each tissue anchor) such that once the tissue anchors are implanted along the tissue, tensioning contraction member 262 can draw the anchors together, thereby reducing the circumference of the valve annulus.

[0228] In some applications, once the implantation assembly 250 is in place, for example with the guide rail 242 threaded through the loop 28 of the tool 280 (FIG. 12B), the tool is positioned along the guide rail at a first site for implantation of the first tissue anchor 260a, which is then facilitated by the tool 280 to be secured to tissue at the first site (e.g., deployed from the distal end of the tool). As mentioned above, the tool 280 can include a driver that can screw the tissue anchor into tissue.

[0229] A second site along the tissue is then selected for implantation of the second tissue anchor 260b, and the tool 280 is advanced along the guide rail 242 such that the loop 28 of the fastener 40 slides over the guide rail and is thereby positioned at the second site (FIG. 12C). The second anchor 260b is secured to the tissue at the second site. The process is repeated with the tool 280 sliding along the guide rail 242 (FIGS. 12D-12E), such that the guide rail provides a track along which the implant will be implanted. The guide rail 242 can thereby define the shape that the implant 264 will take upon implantation. As shown, the tissue anchor 260 can be implanted along the tissue such that the contraction member 262 forms an arc around at least a portion of the valve annulus.

[0230] It should be noted that the number of tissue anchors 260 shown is exemplary and that the implant 264 may include more or fewer tissue anchors.

[0231] In some applications, once implant 264 has been deployed (e.g., implanted) along tissue (e.g., once tissue anchors 260a-g have been secured along tissue), tool 280 is disconnected from guide rail 242 by releasing fasteners 40, e.g., by withdrawing rod 30 from longitudinal member 20, e.g., by withdrawing rod into tool 280 (FIG. 12F). Tool 280 is then withdrawn from the heart, leaving implant 264, and often base frame 240, within the heart as well (FIG. 12G).

[0232] In some applications, adjustment (e.g., contraction) of the annulus is then performed by tensioning the contraction member 262, thereby decreasing the distance between the tissue anchors 260, for example, by causing the contraction member to slide against the tissue anchors. For example, the tensioning tool may be similar or identical to tensioning tool 120 delivered through the sheath 270, but may be modified to facilitate application and maintenance of tension, for example, as described with reference to Figures 9H-I. In some applications, it is hypothesized that such a tensioning tool (e.g., tool 120) cannot be advanced through the sheath 270 in the presence of tool 280, and therefore, it is advantageous for the fastener 40 to facilitate in vivo detachment of tool 280 from the guide rail 242 and the base frame 240 as a whole.

[0233] In some applications, at least a portion of the base frame 240 (e.g., at least a portion of the guide rail 242) includes a radiopaque material that can further facilitate implantation and / or adjustment of the implant 264. For example, mechanical guidance of the tool 280 by the guide rail 242 can be enhanced by fluoroscopic guidance, e.g., guided by at least one fluoroscopic image including the guide rail. For example, fluoroscopy can facilitate identifying the location of the distal end of the tool relative to the guide rail, e.g., the location of the distal end along the guide rail. Similarly, fluoroscopy can be used such that the distal end of the tool is disposed radially outward from the guide rail (i.e., farther from the leaflets of the valve than the guide rail). Additionally, the base frame 240 can be configured to contract during contraction of the valve annulus 10, thereby facilitating fluoroscopic monitoring of the valve annulus 10 while tensioning the contraction member 262. It is therefore hypothesized that in at least some applications, it may be advantageous to hold the base frame 240 in place while the implant 264 is being adjusted, and therefore to allow the fastener 40 to facilitate in vivo detachment of the tool 280 from the base frame.

[0234] The above-described systems, apparatus, devices, implants, methods, and techniques may be used in combination with the systems, apparatus, devices, implants, methods, and / or techniques disclosed in U.S. Provisional Patent Application No. 62 / 877,785, filed July 23, 2019, entitled "Fluoroscopic Visualization of Heart Valve Anatomy," by Sheps et al., and / or PCT Application No. PCT / IL2020 / 050807, filed July 22, 2020, entitled "Fluoroscopic Visualization of Heart Valve Anatomy," each of which is incorporated herein by reference for all purposes, mutatis mutandis. Additionally, the techniques, methods, steps, etc. described or suggested herein or in these incorporated references may be performed in living animals, or in non-living simulations, e.g., cadavers, cadaver hearts, simulators (e.g., simulated body parts, tissues, etc.), and the like.

[0235] It will be appreciated that throughout this application, references to fastener 40 may refer to any of its variations, such as fasteners 40a, 40b, 40c, 40d, and 40e, or combinations thereof.

[0236] Of course, throughout this application, the term "lateral" is not intended to be understood as being precisely perpendicular, but rather means generally across or through. For example, first end 20a may extend laterally through a longitudinal member of a channel site by extending through the longitudinal member at an angle other than 90 degrees relative to the longitudinal member of the channel site. Similarly, rod 30 may extend "laterally" through a longitudinal member at an angle other than 90 degrees relative to the longitudinal member.

[0237] The present invention is not limited to the examples specifically illustrated 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 not present in the prior art that would occur to one of ordinary skill in the art upon reading the above description. Furthermore, the techniques, methods, acts, steps, etc. described or suggested herein can be performed in living animals, or in non-living simulations, such as cadavers, cadaver hearts, simulators (e.g., simulated body parts, tissues, etc.).

Claims

1. A system for use in cardiac tissue, comprising: Spiral member and a guide assembly having a distal portion transluminally advanceable to the heart while in a delivery state, the guide assembly comprising: a guide frame expandable within the heart to an expanded state; Guide rails, and a plurality of fasteners configured to hold the guide rail in a guide arrangement around at least a portion of the guide frame; a guide assembly comprising: a driver configured to be guided by the guide rails while the guide rails are in a guide deployment expanded state and to secure the helical member along an endocardial surface of tissue adjacent the guide frame; A system comprising:

2. The system described in claim 1, wherein the guide frame is self-expanding.

3. The system of claim 1, wherein the system is configured such that the guide assembly facilitates pulling the guide rail and the guide frame out of the heart while the helical member remains within the heart.

4. The system of claim 1, wherein the driver is configured to secure the helical member along the intracardiac surface of the tissue by advancing the helical member over the guide rail.

5. The system described in claim 1, wherein in the guide arrangement, the guide rail is held in an arc around at least a portion of the guide frame by the fastener.

6. The system described in claim 1, wherein each fastener can be opened within the heart to separate the guide frame from the guide rail.

7. The system of claim 1, wherein the driver is configured to fix the helical member along the intracardiac surface of the tissue by rotating the helical member.

8. The system of claim 1, further comprising a sheath, wherein the distal portion of the guide assembly is transluminally advanceable to the heart while in a delivery state within the sheath.

9. The system described in claim 1, wherein the system includes an annular plastic implant, and the helical member is a component of the annular plastic implant.

10. The method of claim 1, wherein the tissue is a cardiac valve annulus, the valve annulus surrounding a valve orifice; the guide assembly is configured to position the guide frame through the orifice such that the guide frame is adjacent to the valve annulus; the endocardial surface of the tissue adjacent the guide frame is an atrial-facing surface of the tissue of the valve annulus; The system of claim 9 , wherein the driver is configured to secure the helical member along the atrium-facing surface of the tissue of the valve annulus.

11. The system of claim 1, wherein the helical member defines a plurality of bends surrounding a central channel of the helical member, and the helical member is fixable along an intracardiac surface of the tissue while the guide rail extends into the central channel.

12. The system described in claim 11, wherein the guide rail is configured to limit the depth of penetration of the helical member into the tissue.

13. The system of claim 11, further comprising a contraction member extending coaxially through the central channel, and a tensioning tool configured to apply tension to the contraction member to axially contract the helical member, thereby contracting the tissue to which the helical member is fixed.

14. The system of claim 13, wherein the guide rail is configured to be withdrawn from the helical member by sliding the guide rail proximally out of the central channel while the helical member remains fixed along the tissue, leaving the contraction member exposed within the central channel.

15. The system described in claim 14, further comprising a stopper coupled to a distal end of the contraction member, wherein tension applied to the contraction member causes the helical member to contract longitudinally by the stopper preventing sliding of the contraction member through the central channel.

16. The system of claim 15, wherein the stopper is a first stopper, and the system further comprises a second stopper configured to lock the tension of the contraction member by being proximally connectable from the helical member to the contraction member.

17. The system of claim 1, wherein the helical member defines a series of bends, and the driver is configured to secure the helical member along the intracardiac surface of the tissue by screwing the helical member along the intracardiac surface of the tissue, such that a portion of each bend is embedded within the tissue and another portion of each bend is positioned outside the tissue.

18. The system of claim 17, wherein the helical member has a constant pitch.

19. A system for use in cardiac tissue, comprising: Implants and a guide assembly having a distal portion transluminally advanceable to the heart while in a delivery state, the guide assembly comprising: a guide frame expandable within the heart to an expanded state; Guide rails, and a plurality of fasteners configured to hold the guide rail in a guide arrangement around at least a portion of the guide frame; a guide assembly comprising: a driver configured to be guided by the guide rails while the guide rails are in a guided configuration and to secure the implant along an endocardial surface of tissue adjacent the guide frame; A system comprising:

20. The system of claim 19, wherein the system is configured such that the guide assembly facilitates withdrawal of the guide rail and the guide frame from the heart while the implant remains within the heart.

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