Tissue conditioning coil induction

Abstract

A system for use in cardiac tissue includes an implant (160) and a delivery assembly (110) including a guide assembly (120) and a driver (116). The guide assembly has a distal portion transluminally advanceable into the heart while in a delivery state and includes (i) a guide frame (124) expandable within the heart toward an expanded state, (ii) guide rails (122), and (iii) a plurality of fasteners (140) tightenable within the heart from a proximal extracorporeal portion of the delivery assembly in a manner that draws the guide rails into a guide device around at least a portion of the guide frame. The driver is configured to advance the implant along the guide rails within the guide device. Other implementations are also described.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application is U.S. Provisional Patent Application No. 63 / 483,513 to Haberman-Browns et al., filed February 6, 2023; U.S. Provisional Patent Application No. 63 / 452,680 to Haberman-Browns et al., filed March 16, 2023; and Priority is claimed to U.S. Provisional Patent Application No. 63 / 613,561 to Haberman-Browns et al., filed December 21, 2023.

[0002] Each of the above references is incorporated herein by reference in its entirety. [Background technology]

[0003] The heart or portions thereof may expand and grow under certain conditions. Dilation of the annulus of a heart valve may occur due to various cardiac conditions, such as enlargement of a heart chamber or leakage of a heart valve. Cardiac remodeling or annuloplasty may be necessary to reshape, reinforce, or tighten the heart and / or valve annulus. Annuloplasty may be performed, for example, by implanting an annuloplasty implant that reshapes and / or resizes the annulus to reduce the size of the annulus. Summary of the Invention

[0004] This Summary is intended to provide some examples and is not intended to limit the scope of the present disclosure in any way. For example, any features included in an example of this Summary are not required by a claim unless the claim explicitly recites those features. Also, the described features can be combined in various ways. Various features and steps described elsewhere in this disclosure may be included in the examples summarized herein.

[0005] In some implementations, methods, systems, devices, apparatus, assemblies, etc. for implanting an implant along tissue, for example along a cardiac annulus, and / or for guiding the implantation using various guide assemblies, as described below.

[0006] In some implementations, the implant is adapted to adjust (e.g., reduce) a dimension (e.g., circumference) of tissue (e.g., a valve annulus). For example, the implant can be an annuloplasty implant configured to reduce regurgitation of an atrioventricular valve of the heart.

[0007] In some implementations, the implant may include a helical member (e.g., a coil), such as an anchor having a helical shape adapted to be anchored along tissue of a valve annulus and then axially contracted (e.g., compressed) to contract (e.g., compress) the tissue. For example, this contraction may be used to circumferentially reduce the size of the valve annulus.

[0008] In some implementations, the helical member is adapted to be anchored in tissue (i.e., screwed into tissue) via rotation, hi some implementations, the threaded axis of the helical member can be positioned substantially parallel to the surface of the tissue such that each turn of the helix can be disposed partially within and partially outside the tissue after implantation of the helical member.

[0009] In some implementations, a guide assembly is used that includes a guide rail adapted to position and guide the implantation of the helical member along the tissue, for example, at least in part by assuming the shape that the helical member takes upon its implantation.

[0010] In some implementations, the guide rails can extend along the tissue to provide a track along which the helical member travels. In some implementations, once the guide assembly is in place, the helical member is advanced along the guide rails (e.g., incrementally threaded onto the guide rails), so that the guide rails direct the implantation of the implant along the tissue.

[0011] In some implementations, the guide rail may be arcuate around at least a portion of the annulus of the heart valve, thereby allowing the helical member to be anchored in an arc around at least a portion of the annulus.

[0012] In some implementations, the guide assembly can also include a guide frame adapted to position the guide rail along the annulus. During dilation and at the native valve, the guide frame can be pressed against the tissue of the annulus.

[0013] In some implementations, the valve can continue to function at least partially even when the guide frame is expanded and / or pressed against tissue, for example, because the guide frame is open and allows blood flow therethrough and / or the valve leaflets remain partially functional.

[0014] In some implementations, the guide assembly may include multiple fasteners distributed along a portion of the guide frame (e.g., collectively describing an arc around the central section of the guide frame) to facilitate positioning of the guide frame along the annulus of the guide rail.

[0015] In some implementations, each of these fasteners forms a respective loop that is looped around a part (eg, a post) of the guide frame and guide rail.

[0016] In some implementations, the guide rails may extend through the loops (e.g., by being threaded through the loops) such that the guide rails extend circumferentially (e.g., in an arc) around at least a portion of the guide frame. Thus, when the guide frame is expanded and placed within the native valve (with the guide rails positioned along the central section of the guide frame), this arrangement positions the guide rails along the tissue of the annulus (e.g., in contact with the atrial surface of the annulus).

[0017] In some implementations, the fasteners (e.g., loops) are formed from one or more longitudinal members (e.g., strands of thread, sutures, ribbons, ropes, wires, cables, or strings), e.g., each longitudinal member defining a respective loop.

[0018] In some implementations, the longitudinal member extends from an extracorporeal proximal portion of the delivery assembly of the system through the guide assembly and forms a loop in the guide frame, e.g., on its outer surface. From the interior of the guide frame, the longitudinal member can extend out of the guide frame (e.g., between its struts), loop around the guide rails to define a loop, and return to the interior of the guide frame.

[0019] In some implementations, the longitudinal member can then return through the guide assembly and out of the subject (eg, a live subject or a simulation).

[0020] In some implementations, releasing the loops from the implant (e.g., once the implant is fully embedded along the tissue) is achieved by simply releasing one end of each longitudinal member and pulling the other end of the longitudinal member (e.g., from outside the subject) until the longitudinal member is unlooped from the guide rail.

[0021] In some implementations, the guide assembly includes a plurality of spacers that maintain spacing between the guide rail and the guide frame even while the loop pulls the guide rail toward the guide frame. In some implementations, this spacing can advantageously facilitate anchoring of the helical member by allowing a sharp tip of the helical member to pass between the guide rail and the guide frame as the helical member rotates. For example, in some implementations, this spacing can reduce the likelihood of the helical member getting caught or threaded onto the guide frame and / or fastening the guide frame to tissue.

[0022] In some implementations, the spacers are wires that extend longitudinally along the outer surface of at least the central section of the guide frame (e.g., perpendicular to the central section). In some implementations, each individual wire is looped to form two spacers, e.g., on opposite sides of the guide frame. For example, each individual wire can be looped around the downstream end of the guide frame.

[0023] In some implementations, the guide rail includes a plurality of imaging markers (eg, fluorescent markers and / or immunogenic markers) spaced along the guide rail at predetermined intervals.

[0024] In some implementations, imaging markers can be used to visualize the procedure and / or to verify a particular step of the procedure, e.g., before proceeding to a subsequent step. For example, imaging markers can be used to verify the position of the guide rails around the guide frame (e.g., around its central section), e.g., to verify that the guide rails are positioned in a manner that facilitates placement of the guide rails along (e.g., parallel to) the annulus.

[0025] In some implementations, the positioning of the guide rail is guided by detection of electrophysiological signals generated by the heart and / or tissue bioimpedance. In some such implementations, the guide rail includes multiple electrodes spaced along the guide rail. For example, in some implementations, the electrodes may be used to verify the position of the guide rail around the guide frame (e.g., around its central section), e.g., to verify that the guide rail is positioned in a manner that facilitates placement of the guide rail along (e.g., parallel to) the valve annulus.

[0026] In some implementations, the data processing system may be adapted to associate various electrical signals detected by the electrodes with corresponding positions of the electrodes within the heart (e.g., different tissues of the heart, or different positions along the atrioventricular axis of the heart), so that prior to implantation of the helical member, it may be determined that the guide rail is sufficiently positioned in the heart (e.g., along the annulus, e.g., in alignment with the atrial surface of the annulus) before driving the helical member through the tissue of the annulus.

[0027] In some implementations, the imaging marker may be conductive so that it functions as an electrode as described herein in addition to facilitating visualization of the procedure.

[0028] In some implementations, the imaging markers and / or electrodes can provide a user with information regarding the desired size of the implant before delivering the implant to the heart. For example, once the guide rail is positioned within the heart, the desired length of the helical member can be determined based on the length of the guide rail positioned along the annulus. In some implementations, this length range can be obtained by determining the percentage of the guide rail positioned along the annulus, for example, by visualizing imaging markers spaced along the guide rail and / or by detecting electrical signals via electrodes spaced along the guide rail.

[0029] In some implementations, during delivery of the guide assembly to the heart (e.g., transluminal delivery), the guide assembly is constrained in a delivery state, e.g., within a sheath, in which the guide frame is compressed radially inward (e.g., in a substantially narrow and / or elongated configuration).

[0030] In some implementations, in the delivery state, the guide rails are disposed along (e.g., substantially parallel to) the compressed guide frame. In some implementations, in the delivery state, the guide rails are at least partially curved (e.g., spiral) around the compressed guide frame.

[0031] In some implementations, once the guide assembly is positioned within the heart (eg, once deployed out of the sheath), the guide frame can be radially expanded within the heart.

[0032] In some implementations, the fastener (e.g., loop) can then be tightened, e.g., in a manner that pulls the guide rail into alignment along the central section so that the guide rail extends circumferentially around at least a portion of the central section. As described herein above, for implementations in which the guide assembly includes a spacer, the spacer maintains spacing between the guide rail and the guide frame, e.g., is sandwiched between the guide rail and the guide frame upon tightening of the loop.

[0033] In some implementations, tightening of the fasteners is achieved by sequentially pulling, for each fastener (e.g., for each loop), one or both ends of the longitudinal member of that loop from outside the subject (e.g., a live subject or a simulation).

[0034] In some implementations, different points along the guide rails may be positioned at different distances from the central section before the guide assembly reaches its deployed state. Thus, the loops may have different exposed lengths (i.e., exposed lengths outside the guide frame) to accommodate the resulting different distances between the guide rails and the loop's exit site from the guide frame, for example. Thus, during tightening of the loops, the longitudinal member of each loop can be pulled by different amounts to accommodate the different exposed lengths, so as to retract the guide rails into alignment with the central section.

[0035] In some implementations, adjustment of the guide rails can be guided by electrodes spaced therealong. For example, during tightening of the loops, electrical signals detected by the electrodes can guide the amount that the longitudinal member of each loop is pulled to facilitate retracting the guide rails into alignment with the central section, e.g., by determining the orientation of the guide rails along the atrioventricular axis.

[0036] Alternative and / or additional techniques for guiding the helical member along the annular tissue using a guide assembly are also described. In some implementations, the guide assembly does not include a guide frame for positioning the guide rails of the guide assembly.

[0037] In some implementations, guide rails (e.g., similar to those described herein above) are positioned around the annulus using any of the techniques described herein below.

[0038] In some implementations in which a guide frame is used, the guide rails can be positioned around the annulus (e.g., along the entire path along which the helical member is anchored) before advancing the helical member along the guide rails.

[0039] In some implementations where the guide assembly does not include a guide frame, the guide rails can be incrementally advanced along the annulus by anchoring of the helical members.

[0040] In some implementations, for each such increment, a leading (e.g., distal) segment of the guide rail may be advanced over the helical member and seated along a portion of the annulus, and the helical member may then be helically advanced over the leading segment so as to be anchored along that portion of the annulus. This may be repeated iteratively until the helical member is anchored along a desired stretch of the annulus. Such incremental advancement of the guide rail may advantageously provide enhanced control and / or positioning of the guide rail and / or helical member, for example, in lieu of the guide frame described above.

[0041] In some implementations in which the guide rail is progressively advanced along the annulus in conjunction with anchoring of the helical member, the leading segment of the guide rail that extends beyond the helical member can be positioned (e.g., to a desired alignment with the annulus) prior to threading of the helical member. Several techniques for such positioning are disclosed.

[0042] In some implementations, the electromagnet is used to guide the leading segment of the guide rail relative to the tissue, for example, using magnetic repulsion and / or attraction between the electromagnet and the leading segment of the guide rail. In some implementations, the electromagnet can be moved incrementally with the guide rail, for example, as the helical member is advanced.

[0043] In some implementations, an example of positioning the leading segment of the guide rail includes adjusting the curvature of the leading segment by heating the leading segment, which in some implementations can be provided by one or more heating elements positioned along the leading segment of the guide rail.

[0044] In some implementations, the guide rail (e.g., its leading segment) may include or be made from a shape memory alloy such as Nitinol, with a transition temperature set above body temperature, such that the guide rail bends or straightens in response to heating.

[0045] In some implementations, positioning the leading segment of the guide rail along the annulus includes a guide rail having an inner tube and an outer tube that has a different resting curvature relative to the inner tube (e.g., the inner tube is straighter at rest than the outer tube at rest). In some implementations, sliding the inner tube axially through the outer tube changes the curvature of the leading segment of the guide rail, for example, by increasing and decreasing the influence of the inner and outer tubes on each other.

[0046] In some implementations, positioning of the guide assembly components (e.g., its guide rails) prior to anchoring the helical member along the valve annulus can be guided by detection of electrophysiological signals generated by the heart and / or tissue bioimpedance. Similar techniques can be used to guide and / or monitor anchoring of the helical member itself. For example, electrodes on the guide assembly (e.g., on the guide rails) and / or on the helical member can be used for such detection. Such electrodes can be separate components, but in some implementations, the implant components themselves can function as electrodes (e.g., because they are inherently conductive).

[0047] In some implementations, electrodes on the guide assembly (e.g., on the guide rails) and / or on the helical member may be used for such detection. Such electrodes can be separate components, although in some implementations, components of the implant themselves can function as electrodes (e.g., because they are inherently conductive).

[0048] In some implementations, prior to implanting the implant into the heart, a control device (e.g., a surgeon, interventionist, and / or data processing system) can receive information regarding the desired implantation site within the heart of the implant. In some implementations, it can be important that the helical member is anchored precisely according to the surgical plan in order for the implant to serve its desired purpose.

[0049] In some implementations, where the implant is an annuloplasty implant for implantation around the annulus of a heart valve, it may be desirable to anchor the helical member within the annulus, for example, to drive the helical member through the atrial surface of the annulus, and therefore, in some implementations, it may not be desirable to anchor the helical member to other tissue, such as in the atrial wall upstream of the valve or the ventricular wall downstream of the valve.

[0050] In some implementations, the helical member (e.g., its distal tip) may be used as an electrode before and / or during driving of the helical member into tissue, and a data processing system electrically connected to the helical member via the electrode may acquire electrical signals generated by the heart. Based on this information, in some implementations, the data processing system may provide an indication of the position of the helical member within the heart that an operator (e.g., a physician) may use to facilitate optimal anchoring and / or positioning of the helical member.

[0051] In some implementations, the data processing system may be adapted to associate various electrical signals with corresponding locations of the electrodes within the heart (e.g., different tissues of the heart or different locations along the atrioventricular axis of the heart).

[0052] In some implementations, a signal obtained from a helical member placed against tissue of the annulus differs from a signal obtained from the same helical member placed against tissue of the atrium or against tissue of the ventricle.

[0053] In some implementations, a continuous signal is provided during anchoring of the helical member along the tissue, such that the data processing system can detect changes in the signal that indicate that the helical member has been anchored deep enough into the tissue with each rotation and / or whether the path of the helical member has deviated from its intended path along the valve annulus. For example, an abrupt change in the signal and / or pattern of signals may indicate deviation of the helical member into the tissue of the atrium or leaflets of the valve.

[0054] In some implementations, the data processing system is electronically coupled to the helical member via a driver used to drive the helical member into tissue. For example, a wire having a connector (e.g., a crocodile clip) on its end may extend from the data processing system and be mechanically and electrically connected (e.g., clipped) to a portion of the conductive shaft of the driver that is positioned outside the subject (e.g., a live subject or simulation).

[0055] In some implementations, the data processing system also receives, for example, an electrical signal (e.g., a second electrical signal) from an additional component of the implantation system (e.g., from the guide assembly of the implant, such as from the guide rail and / or from an additional component of the implant itself) in addition to the electrical signal from the helical member (which may be referred to as the first electrical signal).

[0056] In some implementations, this additional component may be considered a second electrode, and the helical member is referred to as the first electrode. From the first and second signals, the data processing system may be configured to derive a refinement signal that is improved (e.g., has a better signal-to-noise ratio) compared to the first signal alone.

[0057] Additionally and / or alternatively to using the helical member as an electrode, in some implementations, in order to implant the helical member along the valve annulus as needed, it may be important to determine prior to implantation that the components of the guide assembly are satisfactorily positioned in the heart so that the helical member is correctly positioned within the heart upon implantation.

[0058] In some implementations where the implant is an annuloplasty implant for implantation around the annulus of a heart valve, it may be desirable to position the guide rail of the guide assembly along the annulus (e.g., aligned with the atrial surface of the annulus) before driving the helical member through the tissue of the annulus.

[0059] In some implementations, the guide rail may include electrodes through which a data processing system electrically connected to the guide rail can acquire electrical signals generated by the heart. Based on this information, in some implementations, the data processing system can provide an indication of the position of the guide rail within the heart that an operator (e.g., a physician) can use to facilitate optimal positioning of the guide rail.

[0060] Also disclosed are techniques for positioning an implant, such as a replacement heart valve, at a heart annulus guided by electrodes disposed on the implant. Similar to the techniques described above, in which multiple electrodes are positioned around a guide rail such that positioning of the guide rail along the annulus can be guided by the electrodes, the implant or replacement heart valve may use electrodes and may include multiple electrodes distributed along the periphery (e.g., periphery) of the implant or replacement valve to verify tissue contact with the annulus.

[0061] In some implementations, before and / or during implantation of an implant or replacement valve into the heart, a control device (e.g., a surgeon, interventionist, and / or data processing system) can receive information regarding the desired implantation site of the implant / valve within the heart. For the implant to serve its desired purpose, it can be important that the implant or replacement valve be precisely secured according to the surgical plan. For example, it may be desirable to secure the implant or replacement valve at a specific height within the native valve.

[0062] In some implementations, the data processing system may be adapted to associate various electrical signals with corresponding positions of the electrodes within the heart (e.g., different tissues of the heart or different positions along the atrioventricular axis of the heart) so that an operator can verify that the implant or replacement valve is satisfactorily positioned, for example, before anchoring the implant or replacement valve to the valve annulus.

[0063] According to some implementations, the system and / or device (which may be used in a heart, e.g., a live subject or a simulated heart) includes an implant and / or a delivery assembly. The delivery assembly may include a guide assembly, a distal portion of which may be transluminally advanceable into the heart while in a delivery state.

[0064] In some implementations, the guide assembly may include a guide frame and / or a guide rail.

[0065] In some implementations, the guide frame can be expandable within the heart toward an expanded state.

[0066] In some implementations, the delivery assembly may include a plurality of fasteners that can be tightened within the heart from a proximal extracorporeal portion of the delivery assembly in a manner that draws the guide rail into the guide device around at least a portion of the guide frame.

[0067] In some implementations, the delivery assembly can include a driver configured to advance the implant along the guide rails within the guide device.

[0068] In some implementations, each of the fasteners is a suture.

[0069] In some implementations, the guide rail defines a plurality of imaging markers.

[0070] In some implementations, the delivery assembly is configured to facilitate the guide assembly withdrawing the guide rails and guide frame from the heart while the implant remains within the heart.

[0071] In some implementations, in the delivery state, the guide rail is disposed along the guide frame.

[0072] In some implementations, the guide rail is a hypotube.

[0073] In some implementations, the helical member has an axial length of 5 to 12 cm.

[0074] In some implementations, the guide assembly is configured to expand the guide frame before the guide rail is retracted into the guide device.

[0075] In some implementations, the guide assembly is configured to expand the guide frame following retraction of the guide rail into the guide device.

[0076] In some implementations, the guide frame is self-expanding.

[0077] In some implementations, the implant is sterilized.

[0078] In some implementations, at least the distal portion of the guide assembly is sterilized.

[0079] In some implementations, the driver is sterilized.

[0080] In some implementations, the multiple fasteners are tightenable independently of the expanded state of the guide frame.

[0081] In some implementations, the guide rail includes a series of electrodes spaced along the guide rail and electrically connected to the extracorporeal portion of the delivery assembly.

[0082] In some implementations, the electrodes are radiopaque.

[0083] In some implementations, each of the electrodes is a ring electrode positioned around the guide rail.

[0084] In some implementations, the system further includes a data processing system electrically connectable to the one or more electrodes by connecting to terminals on the external portion of the delivery assembly, and configured to (i) receive electrical signals from the one or more electrodes and / or (ii) provide an output indicative of the position of the guide rail within the heart in response to the electrical signals.

[0085] In some implementations, (i) the position includes proximity of the guide rail to the tissue surface, and / or (ii) the data processing system is configured to provide an output indicative of proximity of the guide rail to the tissue surface in response to the electrical signal.

[0086] In some implementations, (i) the position includes contact of the guide rail with the tissue surface, and / or (ii) the data processing system is configured to provide an output indicative of contact of the guide rail with the tissue surface in response to the electrical signal.

[0087] In some implementations, (i) the position is a position along the atrioventricular axis of the heart, and / or (ii) the data processing system is configured to provide an output in response to the electrical signal that indicates the position of the guide rail along the atrioventricular axis.

[0088] In some implementations, (i) the output indicates the type of tissue that the guide rail contacts, and / or (ii) the data processing system is configured to provide an output indicative of the type of tissue in response to the electrical signal.

[0089] In some embodiments, (i) the electrical signal is an ECG signal, and / or (ii) the data processing system is configured to receive an ECG signal.

[0090] In some implementations, (i) the electrical signal is an exogenous signal, and / or (ii) the data processing system is configured to receive the exogenous signal.

[0091] In some implementations, (i) based on the exogenous signal, the data processing system is configured to determine a bioimpedance of the tissue, and / or (ii) the data processing system is configured to provide an output in response to the bioimpedance.

[0092] In some implementations, the data processing system is configured to drive an exogenous signal between at least two of the electrodes in series.

[0093] In some implementations, the guide assembly includes a plurality of spacers disposed around the guide frame and configured to maintain spacing between the guide rail and the guide frame.

[0094] In some implementations, (i) in the guide apparatus, the guide rails are positioned around a central section of the guide frame, the central section being longitudinally disposed between an upstream section of the frame and a downstream section of the frame, and / or (ii) the plurality of spacers are collectively defined by elongated members that extend in a serpentine manner around the central section of the guide frame.

[0095] In some implementations, (i) in the guide device, the guide rails are positioned around a central section of the guide frame, with the central section being longitudinally disposed between the upstream section of the frame and the downstream section of the frame, and / or (ii) each spacer extends longitudinally along part of the upstream section, the entire central section, and part of the downstream section.

[0096] In some implementations, each of the spacers has (i) an upstream end attached to the guide frame in the upstream section, and / or (ii) a downstream end disposed in the downstream section.

[0097] In some implementations, each of the spacers is in the form of a ribbon.

[0098] In some implementations, the downstream end is attached to the guide frame at the downstream section.

[0099] In some implementations, the downstream end is not attached to the guide frame at the downstream section.

[0100] In some implementations, (i) in the guide device, the guide rails are positioned around a central section of the guide frame, the central section being axially disposed between the upstream section of the frame and the downstream section of the frame, and / or (ii) the spacers collectively form a shield around the central section, the shield covering the central section.

[0101] In some implementations, the spacer is operable to expand the guide frame.

[0102] In some implementations, each of the spacers is woven along the guide frame.

[0103] In some implementations, the spacer is operable to compress the guide frame.

[0104] In some implementations, each of the spacers is a wire that extends longitudinally along the guide frame.

[0105] In some implementations, the guide assembly includes a plurality of wires that extend distally along the guide frame, around the distal end of the guide frame, and return proximally along the guide frame, such that each of the plurality of wires defines a pair of spacers on opposite sides of the guide frame.

[0106] In some implementations, each of the plurality of fasteners defines a loop around the guide rail.

[0107] In some implementations, each of the loops is looped around a respective post of the guide frame.

[0108] In some implementations, each of the plurality of fasteners is configured to release the guide rail by unlooping from around the guide rail.

[0109] In some implementations, each fastener of the plurality of fasteners is defined by a longitudinal member that extends from the extracorporeal portion to a distal site, where the longitudinal member forms a loop.

[0110] In some implementations, the guide assembly is positionable at a location within the heart such that (i) the guide rail is positioned along the exterior of the guide frame at the upstream section of the guide frame, (ii) one or more of the plurality of fasteners exit the guide frame at the downstream section of the guide frame and extend along the exterior of the guide frame to the guide rail, and / or (iii) the one or more fasteners are tightenable within the heart in a manner such that the one or more fasteners pull the guide rail toward the downstream section, thereby drawing the guide rail into the guide device.

[0111] In some implementations, the position of the guide assembly within the heart is such that (a) the upstream section and guide rail are upstream of the tissue, and / or (b) the downstream section is downstream of the tissue, and while the guide assembly remains in position, the fasteners can be tightened within the heart in a manner that the fasteners pull the guide rails against the upstream surface of the tissue, thereby drawing the guide rails into the guide device.

[0112] In some implementations, in the delivered state, each of the multiple fasteners has an exposed length where the fastener extends out from the guide frame to the guide rail, and the multiple fasteners have different exposed lengths from one another.

[0113] In some implementations, the multiple fasteners are arranged in a series around the guide frame, such that in the delivered state, each subsequent fastener along the series has a greater exposed length than the preceding fastener.

[0114] In some implementations, the tissue is tissue of an annulus of a heart valve, and the guide assembly is configured to position the guide rail within the guide device and relative to the annulus.

[0115] In some implementations, the guide assembly is configured to position the guide rail relative to the annulus following positioning of the guide rail within the guide device.

[0116] In some implementations, the guide assembly is configured to position the guide frame to traverse the valve, with an upstream section of the guide frame upstream of the valve and a downstream section of the guide frame downstream of the valve.

[0117] In some implementations, (a) each fastener of the plurality of fasteners extends out from the guide frame at a downstream section of the guide frame, (b) the guide assembly is positionable within the heart such that the guide rail is upstream of the annulus, and / or (c) the fasteners are tightenable within the heart in a manner such that the fasteners pull the guide rail against the upstream surface of the annulus, thereby retracting the guide rail against the annulus.

[0118] In some implementations, the guide assembly is configured to expand the guide frame while the guide frame remains traversing the valve.

[0119] In some implementations, the guide assembly is configured to expand the guide frame prior to positioning the guide frame to traverse the valve.

[0120] In some implementations, the guide assembly is configured to apply an expansion force to the guide frame to expand the guide frame within the heart toward the expanded state.

[0121] In some implementations, the guide assembly includes a mechanical actuator operable to apply an expansive force.

[0122] In some implementations, the guide assembly includes a balloon that is inflatable to apply the expansive force.

[0123] In some implementations, the implant includes a flexible helical member that defines a plurality of turns.

[0124] In some implementations, the helical member has a constant pitch.

[0125] In some implementations, the helical member has a sharp distal tip.

[0126] In some implementations, the implant has a head at a proximal end of the helical member. In some implementations, the driver is configured to engage the implant by engaging the head. In some implementations, the helical member has a greater thickness toward the proximal end than toward the distal tip.

[0127] In some implementations, the thickness of the helical member tapers gradually from the distal tip to the proximal end.

[0128] In some implementations, the helical member has greater stiffness towards the proximal end than towards the distal tip.

[0129] In some implementations, the driver is configured to anchor the implant along and on the guide rails along the tissue by rotating the helical member in a first direction such that the distal tip penetrates the tissue, hi some implementations, the helical member is deliverable along and on the guide rails toward the tissue while rotating the helical member in a second direction, the second direction being opposite to the first direction.

[0130] In some implementations, the guide assembly is configured to position the guide rail within the guide device along the surface of the tissue.

[0131] In some implementations, the driver is configured to anchor the implant along the tissue by threading the helical member along the guide rail and the tissue while the guide rail in the guide device is positioned along the surface of the tissue, such that a portion of each turn of the helical member is embedded in the tissue and another portion of each turn is positioned above the surface of the tissue.

[0132] In some implementations, the guide rail defines a groove, and the driver is configured to anchor the implant along the tissue by threading the helical member onto and along the guide rail while the helical member is threadably engaged with and recessed within the groove.

[0133] In some implementations, the extracorporeal portion of the delivery assembly is electrically connected to the helical member and adapted to apply electrical energy to the helical member, hi some implementations, the helical member is configured to contract in response to the application of electrical energy in a manner that draws the turns of the helical member closer together.

[0134] In some implementations, the extracorporeal portion includes a power source configured to provide electrical energy.

[0135] In some implementations, the extracorporeal portion (i) includes terminals configured to be electrically and mechanically connected to a power source, and / or (ii) is configured to derive electrical energy from the power source.

[0136] In some implementations, the driver is electrically conductive and electrically connects the extracorporeal portion to the helical member.

[0137] In some implementations, the helical member is sufficiently flexible to follow the curvature of the guide rails in the guide device.

[0138] In some implementations, the guide rail is configured to limit the depth of penetration of the helical member into tissue.

[0139] In some implementations, the implant further includes a tension member.

[0140] In some implementations, in the guide apparatus, the tension member extends through the guide rail.

[0141] In some implementations, the multiple turns surround a central channel of the helical member, and the delivery assembly is configured to retract the guide rails out of the helical member while the helical member remains anchored along the tissue, leaving a tensioning member extended through the central channel such that the tensioning member, when tensioned, axially contracts the helical member.

[0142] In some implementations, the system further includes a stopper coupled to the distal end of the tension member, such that tension applied to the tension member causes the helical member to contract longitudinally, with the stopper preventing the tension member from sliding through the central channel.

[0143] In some implementations, the system further includes a tensioning tool configured to apply tension to the tensioning member, thereby axially contracting the helical member, thereby contracting tissue along which the helical member is anchored.

[0144] In some implementations, the system further includes a stopper, and the tensioning tool is configured to lock the tensioning force to the tensioning member by locking the stopper to the tensioning member.

[0145] In some implementations, the driver is configured to advance the implant along the guide rail by sliding a helical member over and along the guide rail.

[0146] In some implementations, the plurality of rotating portions surround a central channel, and the guide rails extend through the central channel.

[0147] In some implementations, the central channel has a diameter and the guide rails have a thickness that is at least 50 percent of the diameter of the central channel.

[0148] In some implementations, the driver is configured to advance the implant along the guide rail while threading the helical member into and along the tissue.

[0149] In some implementations, a driver is configured to be engaged with the proximal end of the helical member and to apply a torque to the proximal end of the implant, thereby screwing the implant into tissue.

[0150] In some implementations, the implant includes a head coupled to a proximal end of the helical member, and a driver reversibly engaged with the head.

[0151] In some implementations, the guide frame has a longitudinal axis and is expandable within the heart toward an expanded state by expanding radially away from the longitudinal axis. In some implementations, the guide device has guide rails extending laterally around at least a portion of the guide frame.

[0152] In some implementations, in the delivery state, the guide rails are aligned parallel to the longitudinal axis.

[0153] In some implementations, the system further includes a sheath, wherein a distal portion of the guide assembly is transluminally advanceable to the heart while in a delivery state within the sheath.

[0154] In some implementations, in the guide device, the guide rails extend from the sheath, through the interior of the guide frame, and out of the guide frame at the exit site so as to rest around the exterior of the guide frame.

[0155] In some implementations, the invaginating portion of the guide frame is configured to invaginate and form the invagination when the guide frame is expanded within the heart toward its expanded state.

[0156] In some implementations, the guide assembly includes a control shaft coupled to the guide frame at an indented portion of the guide frame.

[0157] In some implementations, in the delivery state, the guide frame is constrained within the sheath.

[0158] In some implementations, the guide frame is configured to automatically self-expand within the heart once deployed out of the sheath.

[0159] In some implementations, the guide frame comprises (eg, is formed from) braided filaments.

[0160] In some implementations, the filament is a wire.

[0161] In some implementations, each of the fasteners is defined by a longitudinal member that extends from the extracorporeal portion to a distal site where the fastener is engaged with the guide rail.

[0162] In some implementations, the guide frame defines an interior and has an exterior, and in some implementations, at a distal portion, each of the longitudinal members extends from the interior through the guide frame to the exterior, and the fasteners are engaged with the guide rails.

[0163] In some implementations, the guide frame has a longitudinal axis and is expandable within the heart toward an expanded state by expanding radially away from the longitudinal axis.

[0164] In some implementations, at the distal portion, each of the longitudinal members extends laterally from the interior through the guide frame to the exterior, and the fasteners are engaged with the guide rails.

[0165] In some implementations, the guide apparatus includes a guide rail disposed around a central section of a guide frame, the central section being axially disposed between an upstream section of the frame and a downstream section of the frame. In some implementations, the guide frame is a braided structure defined by a plurality of struts.

[0166] In some implementations, in the central section, each strut is twisted with an adjacent strut to form a twisted pair of struts, and each twisted pair of struts defines an eyelet therethrough. In some implementations, each longitudinal member extends from the interior through a respective one of the eyelets to the exterior, and a fastener is engaged with the guide rail.

[0167] In some implementations, each twisted pair of struts is parallel to the longitudinal axis.

[0168] In some implementations, the guide assembly includes a plurality of rods, each of the plurality of rods being tubular.

[0169] In some implementations, at the distal portion, each of the longitudinal members extends out from the respective rod, through the guide frame, and the fasteners are engaged with the guide rails.

[0170] In some implementations, each of the rods has a distal opening disposed on an inner surface of the guide frame.

[0171] In some implementations, the plurality of rods are flexible.

[0172] In some implementations, the plurality of rods are longitudinally incompressible.

[0173] In some implementations, multiple rods extend distally within the interior.

[0174] In some implementations, the guide assembly is configured to position the guide rail within the guide device along a surface of the tissue, and the driver is configured to anchor the implant along the tissue by spirally advancing the implant along the guide rail within the guide device.

[0175] In some implementations, the driver has (i) a drive head at a distal end of the driver that is reversibly engaged with the implant, (ii) a drive shaft, the driver configured to advance the implant helically along the guide rail by torque applied to the drive shaft, and / or (iii) a neck that connects the drive shaft to the drive head in a manner that transmits torque from the drive shaft to the drive head.

[0176] In some implementations, the drive shaft is between 50 and 150 cm long.

[0177] In some implementations, the neck is 0.5 to 5 cm in length.

[0178] In some implementations, both the drive shaft and the neck are formed from a single tube with a first cut pattern along the neck and a second cut pattern cut along the drive shaft, the second cut pattern being different from the first cut pattern.

[0179] In some implementations, the single tube further forms the drive head.

[0180] In some implementations, the first cutting pattern segments the neck into separate vertebrae, and the neck is bendable through movement of the vertebrae relative to one another.

[0181] In some implementations, the vertebrae are articulably coupled to one another via a first cutting pattern.

[0182] In some implementations, the second cutting pattern includes a plurality of transverse slits along the drive shaft, and the drive shaft is bendable through deformation of the tube and the slits.

[0183] In some implementations, the first cut pattern includes a plurality of serpentine cuts distributed along the neck, each of the serpentine cuts completely surrounding the tube.

[0184] In some implementations, the second cutting pattern includes a plurality of slits distributed along the drive shaft, each of the slits incompletely surrounding the tube.

[0185] In some implementations, the delivery assembly further includes a fixed wire connected to the connector of the guide rail in a manner that fastens the connector to a connecting position on the guide frame.

[0186] In some implementations, the connector is an eyelet defined by the distal end portion of the guide rail, and the fixed wire extends outside the guide frame and is looped through the eyelet to fasten the connector to a connection position on the guide frame.

[0187] In some implementations, the fixation wires are retractable from the connectors of the guide rails within the heart to decouple the guide rails from the guide frame.

[0188] In some implementations, the connector is disposed at a distal end portion of the guide rail.

[0189] In some implementations, each fastener is defined by a longitudinal member that extends from the extracorporeal portion to a distal portion of the guide assembly, and the fastener loops around the guide rail, and in some implementations, a fixation wire prevents the guide rail from sliding off the fastener upon fastening to the connector connection location.

[0190] In some implementations, in the guide device, the guide rail is placed around a central section of the guide frame, and the central section is axially disposed between the upstream section of the frame and the downstream section of the guide frame. In some implementations, in the delivery state, the connection location is disposed in the downstream section. In some implementations, the delivery assembly is adapted to translate the guide rail toward the guide device by moving the distal end portion toward the central section.

[0191] In some implementations, the multiple fasteners are arranged in series around the guide frame, and the delivery assembly is adapted to move the distal end portion toward the central section by tightening the most distal fastener of the series.

[0192] In some implementations, the fixation wire is loosenable within the heart to facilitate movement of the distal end portion away from the connection location and towards the mid-section.

[0193] In some implementations, in the delivery state, the guide rail extends distally through the interior of the guide frame and out of the guide frame at the exit site to lie along the exterior of the guide frame.

[0194] In some implementations, the guide frame has a longitudinal axis and is expandable within the heart toward an expanded state by expanding radially away from the longitudinal axis. In some implementations, the guide device has guide rails that extend distally through the interior of the guide frame and out of the guide frame at the exit site to curve around the exterior of the guide frame and the longitudinal axis.

[0195] In some implementations, in the guide device, the guide rails extend distally through the interior of the guide frame and out from the guide frame at the exit site to rest around the exterior of the guide frame.

[0196] In some implementations, the delivery assembly further includes a tube, with the guide rail extending through the tube. In some implementations, the guide device has: (a) the tube extending distally through the interior of the guide frame and out of the guide frame at an exit site; (b) within the tube, the guide rail extending distally through the interior of the guide frame and out of the guide frame at an exit site; and (c) outside the guide frame, the guide rail exits the tube, is exposed from the tube, and rests around the exterior of the guide frame.

[0197] In some implementations, the tube has a distal section that exits the guide frame at an exit site, and at least the distal section of the tube is a flexible sleeve.

[0198] In some implementations, the delivery assembly further includes a tube, and the guide rails extend through the tube. In some implementations, in the guide device, the guide rails extend distally through and out of the tube, exposed from the tube, and rest around the exterior of the guide frame.

[0199] In some implementations, at least the distal section of the tube is a flexible sleeve.

[0200] In some implementations, the sleeve comprises a polymer.

[0201] In some implementations, the sleeve is a woven sleeve.

[0202] In some implementations, the guide assembly is configured to position the guide rail within the guide device along a surface of the tissue. In some implementations, the implant includes a suture. In some implementations, the driver is configured to thread the suture along the tissue by helically advancing the suture along the guide rail within the guide device.

[0203] In some implementations, the implant further includes a tensioning member. In some implementations, the driver is configured to suturing the suture along the tissue such that the suture defines a helix (e.g., a series of turns) along the tissue and the tensioning member extends along the interior of the helix. In some implementations, the implant is configured such that tension in the tensioning member adjusts the dimension of the tissue by pulling the suture.

[0204] In some implementations, the driver is configured to sew the suture such that the helix is ​​disposed in a curved path along the tissue, the curved path having a radius of curvature, hi some implementations, the implant is configured such that tension in the tension member adjusts the dimension of the tissue by reducing the radius of curvature of the curved path.

[0205] In some implementations, the driver is configured to thread the suture such that the helix is ​​disposed in a curved path along the tissue, the curved path having a length, hi some implementations, the implant is configured such that tension in the tension member adjusts the dimension of the tissue by reducing the length of the curved path.

[0206] In some implementations, the tension member is disposed within the lumen of the guide rail, and the delivery assembly is configured to retract the guide rail proximally from the helix, leaving the tension member exposed within the helix.

[0207] In some implementations, the driver includes a helical member and is adapted to suture the suture along the tissue by helically driving the helical member along a guide rail in the guide device such that the helical member is temporarily sutured along the tissue. In some implementations, the delivery assembly is configured to (a) helically retract the helical member to unstitch the helical member from the tissue, and / or (b) linearly retract the guide rail to leave the suture sutured along the tissue with the tension member extending along the interior of the helix.

[0208] In some implementations, the driver includes a helical member adapted to helically drive the helical member along a guide rail in the guide device, thereby suturing the suture along the tissue.

[0209] In some implementations, the suture is attached to the exterior of the helical member.

[0210] In some implementations, the suture is removable from the helical member once the suture has been stitched along the tissue.

[0211] In some implementations, the suture is attached to a distal end portion of the helical member, and the driver is adapted to suture the suture along the tissue by withdrawing the helical member from the tissue such that the suture is drawn into and along the tissue by withdrawal of the helical member.

[0212] In some implementations, the driver is adapted to suturing the suture to the tissue along the helical member.

[0213] In some implementations, the helical member defines a plurality of turns, and the driver is configured to advance the implant along the tissue by threading the helical member and suture into the tissue, such that a portion of each turn of the helical member is embedded in the tissue and another portion of each turn is positioned above the surface of the tissue.

[0214] In some implementations, the helical member is a hollow helical needle defining a channel therethrough, and the driver is configured to thread the helical member along the tissue while the suture is disposed within the channel, thereby suturing the suture along the tissue.

[0215] In some implementations, the driver is configured to unscrew the screw from the tissue, leaving the suture threaded along the tissue.

[0216] In some implementations, the guide apparatus includes a guide rail disposed around a central section of a guide frame, the central section being axially disposed between an upstream section of the frame and a downstream section of the frame, and in some implementations, in an expanded state of the guide frame, the upstream section is wider than the downstream section.

[0217] In some implementations, the guide assembly further includes a control shaft extending from the extracorporeal portion and coupled to the upstream section of the guide frame. In some implementations, the guide assembly includes a plurality of actuator wires operably coupled to the extracorporeal portion.

[0218] In some implementations, each of the actuator wires extends from the control shaft, distally through the interior of the upstream section of the guide frame, and interwoven along the downstream section of the guide frame, such that operation of the extracorporeal portion applies tension to the actuator wires, causing the guide frame to expand radially.

[0219] In some implementations, the upstream section is wider than the middle section.

[0220] In some implementations, in the expanded state, the guide frame is mushroom-shaped.

[0221] In some implementations, in the expanded state, the upstream section projects radially outward across the central section.

[0222] In some implementations, the driver is configured to embed the implant over and along the guide rails along the tissue, hi some implementations, the guide frame is positionable within the heart in an expanded state such that the upstream section protrudes radially outward across the upstream surface of the tissue.

[0223] In some implementations, the guide assembly is configured to move the guide frame downstream in the expanded state until the upstream section projects radially outward across the upstream surface of the tissue.

[0224] In some implementations, the guide assembly is configured to move the guide frame in an expanded state in an upstream direction such that the upstream section presses through the tissue and protrudes radially outward across the upstream surface of the tissue.

[0225] In some implementations, the guide frame defines an upstream section and a downstream section, and a concave waist axially disposed between the upstream section and the downstream section, In some implementations, in an expanded state of the guide frame, the waist has a smaller circumference than both the upstream section and the downstream section.

[0226] In some implementations, the guide assembly further includes a control shaft extending from the extracorporeal portion and coupled to the upstream section of the guide frame.

[0227] In some implementations, the guide assembly includes a plurality of actuator wires operably coupled to the extracorporeal portion and extending through the control shaft to the guide frame, wherein each of the actuator wires extends from the control shaft distally through the interior of the upstream section of the guide frame and interwoven along the downstream section of the guide frame, such that movement of the extracorporeal portion tensions the actuator wires, causing the guide frame to radially expand.

[0228] In some implementations, in the guide apparatus, the guide rail is placed around the waist of the guide frame.

[0229] In some implementations, the guide assembly is adapted to position the guide frame against tissue such that the tissue is sandwiched between the upstream section and the downstream section.

[0230] In some implementations, the guide assembly is adapted to position the guide frame against tissue such that the tissue is grasped between the upstream section and the downstream section.

[0231] In some implementations, the distal end of the guide frame is invaginated to form the invagination.

[0232] In some implementations, the invagination is secured by a crimp.

[0233] In some implementations, the guide frame defines a plurality of struts, the struts being gathered together at the distal end of the guide frame to form an atraumatic distal end of the guide frame.

[0234] In some implementations, the distal end is covered with a coating.

[0235] In some implementations, the distal end is secured by crimping.

[0236] In some implementations, the struts are invaginated to form an atraumatic distal end.

[0237] In some implementations, the guide assembly includes a control shaft, the distal end of which is attached to the guide frame in a manner that facilitates transluminal control of the guide frame via the control shaft.

[0238] In some implementations, the control shaft includes a tube. In some implementations, at a distal region of the control shaft, the control shaft defines a bend zone where cuts in the tube impart flexibility to the tube. In some implementations, the control shaft further includes a strip having a greater tensile strength than the bend zone. In some implementations, a first end of the strip is attached to the tube distal to the bend zone and a second end of the strip is attached to the tube proximally from the bend zone such that the strip lies loose along the bend zone.

[0239] In some implementations, each of the first end of the strip and the second end of the strip is attached to the tube by welding.

[0240] In some implementations, (i) the strip is a first strip, (ii) the control shaft further includes a second strip having a tensile strength greater than the bend zone, and (iii) a first end of the second strip is attached to the tube distally from the bend zone opposite the first end of the first strip, and a second end of the second strip is attached to the tube proximally from the bend zone opposite the second end of the first strip, such that the strip lies loosely along the bend zone opposite the bend zone relative to the first strip.

[0241] In some implementations, the tube is a hypotube.

[0242] In some implementations, the delivery assembly is configured to facilitate withdrawal of the guide frame by pulling the control shaft in a manner that applies tension to the strip.

[0243] In some implementations, (i) the control shaft includes a tube, and (ii) at a distal region of the control shaft, the control shaft defines a bend zone in which a cut pattern in the tube imparts flexibility to the tube, the cut pattern including a plurality of slits distributed along the bend zone, each of the slits incompletely surrounding the tube such that uncut axial strips remain along the bend zone.

[0244] In some implementations, (i) the strip is a first strip, and (ii) the cutting pattern defines a second uncut axial strip along the bend zone, the second strip being positioned on an opposite side of the bend zone from the first strip.

[0245] In some implementations, the tube is a hypotube.

[0246] In some implementations, the guide assembly is operably coupled to the extracorporeal portion and includes a plurality of actuator wires woven longitudinally along at least a portion of the guide frame and attached to a downstream portion of the guide frame, such that application of tension to the actuator wires from the extracorporeal portion causes the guide frame to expand radially.

[0247] In some implementations, the guide device includes a guide rail positioned around a central section of a guide frame, the central section being longitudinally disposed between an upstream section of the frame and a downstream section of the frame, hi some implementations, the guide assembly further includes a control shaft extending from the extracorporeal portion and coupled to the upstream section of the guide frame.

[0248] In some implementations, each of the actuator wires extends from the control shaft, distally through the interior of the upstream section of the guide frame, and weaves along the downstream section of the guide frame.

[0249] In some implementations, in the expanded state of the guide frame, at least a portion of the upstream section is wider than the downstream section.

[0250] In some implementations, in the expanded state of the guide frame, at least a portion of the upstream section is wider than the central section.

[0251] In some implementations, the guide assembly further includes a control shaft extending from the extracorporeal portion and coupled to the upstream section of the guide frame, hi some implementations, the guide assembly is configured such that the guide frame is pivotable relative to the control shaft via differential tension of the actuator wires.

[0252] In some implementations, the extracorporeal portion includes at least one control device to which the actuator wires are operably coupled, hi some implementations, the extracorporeal portion is configured to differentially actuate the actuator wires via actuation of the at least one control device.

[0253] In some implementations, the guide frame is configured to radially expand in response to balanced tension in the actuator wires, hi some implementations, the extracorporeal portion is configured to apply balanced tension to the actuator wires.

[0254] In some implementations, at least one control device is configured with (i) a first operating mode that applies balanced tension to the actuator wires, and / or (ii) a second operating mode that applies differential tension to the actuator wires.

[0255] In some implementations, in the guide apparatus, the guide rail is positioned around a central section of the guide frame, and the central section is axially disposed between the upstream section of the frame and the downstream section of the frame. In some implementations, the guide assembly includes a shield disposed around the central section such that in the guide apparatus, the shield is disposed between the guide rail and the guide frame.

[0256] In some implementations, the shield comprises a resilient material.

[0257] In some implementations, the shield is defined by a woven fabric.

[0258] In some implementations, the shield is defined by a film.

[0259] In some implementations, the shield is defined by a mesh.

[0260] In some implementations, the shield has a hypotube type structure.

[0261] In some implementations, the shield is a ribbon that is wrapped around the guide frame in the delivery state of the guide assembly, and expanding the guide frame toward the expanded state causes the ribbon to slide over itself in a manner that reduces wrapping around the guide frame.

[0262] In some implementations, the shield is defined by a plurality of ribbons distributed circumferentially around the central section.

[0263] In some implementations, in the guide device, each ribbon contacts its adjacent ribbon such that the ribbons collectively cover the central section.

[0264] In some implementations, in the delivery state, the ribbons are stacked in a scale-like manner around the central section, and in some implementations, the ribbons are configured to facilitate expansion of the guide frame toward the expanded state by sliding over each other while collectively covering the central section.

[0265] In some implementations, in the expanded state, the ribbons remain stacked in a scale-like fashion around the central section.

[0266] In some implementations, in the expanded state, the ribbons are disposed edge-to-edge around the central section.

[0267] In some implementations, each ribbon is polymeric.

[0268] In some implementations, each ribbon is metallic.

[0269] In some implementations, in the guide apparatus, the guide rail is placed around a central section of a guide frame, the central section being axially disposed between an upstream section of the frame and a downstream section of the frame. In some implementations, the guide frame is a braided structure defined by a plurality of struts. In some implementations, in the central section, each strut is twisted with an adjacent strut to form a twisted pair of struts.

[0270] In some implementations, each twisted pair of struts is covered with a cover.

[0271] In some implementations, the guide frame defines a longitudinal axis between the upstream section and the downstream section, and each twisted pair of struts is substantially parallel to the longitudinal axis.

[0272] In some implementations, the guide rail defines external threads, hi some implementations, the driver is configured to advance the implant along the guide rail by threadingly advancing the implant along the external threads.

[0273] In some implementations, the external threads define a groove. In some implementations, the implant includes a helical member defining a plurality of turns. In some implementations, the driver is configured to helically thread the helical member along the threads while the helical member is recessed within the groove.

[0274] In some implementations, the guide rail defines a central guide rail axis and has a tissue-facing surface disposed along the guide rail closer to the central guide rail axis than the male threads, hi some implementations, in the guide device, the male threads face inward toward the guide frame and the tissue-facing surface faces radially away from the guide frame.

[0275] In some implementations, the tissue-facing surface is unthreaded and extends parallel to the external threads.

[0276] In some implementations, the tissue-facing surface is substantially flat.

[0277] In some implementations, the tissue-facing surface is concave.

[0278] In some implementations, the guide assembly includes a rider slidably mounted to the guide rail such that as the driver advances the implant along the guide rail, the tip of the implant pushes the rider along the guide rail while the rider shields the guide frame from the tip of the implant.

[0279] In some implementations, the implant includes a helical member defining a sharp tip at its tip, hi some implementations, the rider defines lobes such that when the implant pushes the rider along the guide rail, the lobes remain disposed between the tip and the guide frame, thereby shielding the guide frame from the sharp tip.

[0280] In some implementations, the lobes are rotationally locked relative to the guide rails.

[0281] In some implementations, the lobe is rotationally locked to the guide rail via keying between the rider and the guide rail.

[0282] According to some implementations, the method (which may be used, for example, in a living subject's or a simulated heart) includes transluminally advancing a guide frame into the heart while the guide frame is secured to the guide rail via a plurality of fasteners extending out from the guide frame to the guide rail. In some implementations, the method includes expanding the guide frame within the heart.

[0283] In some implementations, the guide rail can be drawn into the guide arrangement around at least a portion of the guide frame by tightening at least one of the plurality of fasteners.

[0284] In some implementations, the implant can be positioned along the cardiac tissue guided by the guide rails while the guide rails remain within the guide device.

[0285] In some implementations, the method further includes sterilizing the implant.

[0286] In some implementations, the method further includes sterilizing the guide frame.

[0287] In some implementations, the method further includes sterilizing the guide rail.

[0288] In some implementations, retracting the guide rail into the guide device includes retracting the guide rail into the guide device by tightening a first fastener of the plurality of fasteners by a first amount and / or a second fastener of the plurality of fasteners by a second amount, the second amount being greater than the first amount.

[0289] In some implementations, the method further includes, following positioning the implant along the tissue, withdrawing the guide rail and guide frame from the heart while the implant remains positioned along the tissue.

[0290] In some implementations, advancing the guide frame into the heart includes advancing the guide frame into the heart while guide rails are positioned along the guide frame.

[0291] In some implementations, transluminally advancing the guide frame into the heart includes transluminally advancing the guide frame into the heart while the guide frame is constrained in a delivery state within a sheath.

[0292] In some implementations, the guide rail defines a plurality of imaging markers, and retracting the guide rail into the guide device includes retracting the guide rail into the guide device guided by at least one image that includes the imaging markers.

[0293] In some implementations, the method further includes, prior to positioning the implant along the tissue, determining a desired size of the implant guided by at least one image including the imaging markers.

[0294] In some implementations, the method further includes selecting an implant from the selected implants in response to at least one image including the imaging marker before positioning the implant along the tissue.

[0295] In some implementations, the method further includes adjusting a size of the implant in response to at least one image including the imaging markers before positioning the implant along the tissue.

[0296] In some implementations, the method further includes determining a position of the guide rail within the heart in response to the electrical signal detected through the guide rail.

[0297] In some implementations, the method further includes selecting an implant from the selected implants in response to the electrical signal before positioning the implant along the tissue.

[0298] In some implementations, the method further includes adjusting a size of the implant in response to the electrical signal before positioning the implant along the tissue.

[0299] In some implementations, the guide rail defines a plurality of imaging markers. In some implementations, the electrical signal is detected via the imaging markers, which function as electrodes. In some implementations, retracting the guide rail into the guide device includes retracting the guide rail into the guide device guided by at least one image that includes the imaging markers.

[0300] In some implementations, the electrical signal is an intrinsic electrical signal, and determining the position of the guide rail in response to the electrical signal includes determining the position of the guide rail in response to the intrinsic electrical signal.

[0301] In some implementations, the intrinsic electrical signal is an ECG signal, and determining the position of the guide rail in response to the intrinsic electrical signal includes determining the position of the guide rail in response to the ECG signal.

[0302] In some implementations, the electrical signal is an exogenous electrical signal, and determining the position of the guide rail in response to the electrical signal includes determining the position of the guide rail in response to the exogenous electrical signal.

[0303] In some implementations, the method further includes applying an exogenous electrical signal to a subject (e.g., a living subject or a simulation).

[0304] In some implementations, determining the position of the guide rail in response to the exogenous electrical signal includes determining the position of the guide rail in response to sensing a bioimpedance of tissue.

[0305] In some implementations, the method further includes retracting the guide rail into the guide device around a portion of the guide frame, followed by positioning the guide rail within the heart in response to an electrical signal before positioning the implant along the tissue.

[0306] In some implementations, positioning the guide rail within the heart includes determining a position of the guide rail along the atrioventricular axis of the heart.

[0307] In some implementations, determining the position of the guide rail within the heart includes verifying contact between at least a portion of the guide rail and tissue.

[0308] In some implementations, the guide rail has a series of electrodes spaced along the guide rail, and the electrical signal is one of a plurality of electrical signals received via the series of electrodes. In some implementations, positioning the guide rail within the heart includes positioning the guide rail within the heart in response to the plurality of electrical signals.

[0309] In some implementations, positioning the implant along the tissue includes positioning the implant along a stretch of tissue.

[0310] In some implementations, adjusting the position of the guide rail includes adjusting the position of the guide rail such that (i) an electrical signal received from a first portion of the guide rail positioned along the extension indicates the presence of tissue contact, and (ii) an electrical signal received from a second portion of the guide rail positioned away from the tissue indicates the absence of tissue contact.

[0311] In some implementations, transluminally advancing the guide frame into the heart includes transluminally advancing the guide frame into the heart while the guide frame is constrained in a delivery state within a sheath.

[0312] In some implementations, expanding the guide frame within the heart includes deploying the guide frame out of a sheath such that the guide frame automatically self-expands within the heart.

[0313] In some implementations, the guide frame has a longitudinal axis, and expanding the guide frame includes expanding the guide frame radially away from the longitudinal axis.

[0314] In some implementations, in the guide apparatus, the guide rail extends laterally around at least a portion of the guide frame.

[0315] In some implementations, advancing the guide frame into the heart includes advancing the guide frame into the heart while the guide rails are positioned parallel to the longitudinal axis.

[0316] In some implementations, expanding the guide frame within the heart includes applying an expansion force to the guide frame within the heart.

[0317] In some implementations, applying the expansive force includes actuating a mechanical actuator within the heart.

[0318] In some implementations, applying the expansive force includes inflating a balloon within the heart.

[0319] In some implementations, positioning the implant along the tissue includes threading the implant into and along the tissue in a manner that the implant is threaded incrementally around the guide rail.

[0320] In some implementations, the implant further includes a helical member defining a plurality of turns, and the method further includes applying energy to the helical member while the helical member remains threaded into and along the tissue, such that in response to the application of energy, the helical member contracts in a manner that draws the turns of the helical member toward each other.

[0321] In some implementations, applying energy to the helical member includes applying electrical energy to the helical member from an external power source electrically connected to the helical member.

[0322] In some implementations, threading the helical member into tissue includes applying a torque to a proximal end of the helical member to thread the helical member into tissue.

[0323] In some implementations, the helical member defines a sharp distal tip. In some implementations, the helical member has a greater thickness toward the proximal end than toward the distal tip. In some implementations, applying a torque to the proximal end of the helical member includes applying a torque to the proximal end of the helical member toward which the thickness is greater.

[0324] In some implementations, the thickness of the helical member is tapered so that it gradually increases from the distal tip to the proximal end, and threading the helical member into tissue comprises threading the tapered helical member into tissue.

[0325] In some implementations, the helical member defines a sharp distal tip. In some implementations, the helical member has a greater stiffness toward the proximal end than toward the distal tip. In some implementations, applying a torque to the proximal end of the helical member includes applying a torque to the stiffer proximal end of the helical member toward which it is stiffer.

[0326] In some implementations, applying a torque to the proximal end of the helical member includes applying a torque to the proximal end of the helical member in a first direction such that a distal tip of the helical member penetrates the tissue. In some implementations, the method further includes delivering the helical member over and along the guide rail toward the tissue while rotating the helical member in a second direction before threading the helical member along the tissue, the second direction being opposite to the first direction.

[0327] In some implementations, threading the helical member into the tissue includes threading the helical member into the tissue such that a threaded axis of the helical member is disposed along a surface of the tissue.

[0328] In some implementations, the method further includes retracting the guide rails from the implant after positioning the implant along the tissue, leaving the implant implanted in the heart.

[0329] In some implementations, retracting the guide rail from the implant includes sliding the guide rail proximally through the implant.

[0330] In some implementations, the implant includes a helical member defining a plurality of turns surrounding a central channel, hi some implementations, threading the implant into and along the tissue includes threading the helical member into the tissue such that a portion of each turn of the helical member is embedded in the tissue and another portion of each turn rests above the surface of the tissue.

[0331] In some implementations, the helical member defines a sharpened distal tip, and threading the helical member into tissue includes repeatedly driving the sharpened distal tip into and out of the tissue.

[0332] In some implementations, the implant further includes a tension member, and the method further includes, following implanting the helical member along the tissue, axially contracting the helical member by applying tension to the tension member.

[0333] In some implementations, the helical member includes a head, and screwing the helical member into tissue includes screwing the helical member into tissue using a driver engaged with the head.

[0334] In some implementations, the tissue is tissue of a heart valve annulus, and / or positioning the implant along the tissue guided by the guide rail includes advancing the implant along the tissue of the valve annulus guided by the guide rail.

[0335] In some implementations, positioning the implant along the tissue includes threading the implant into and along the atrial surface of the annulus tissue.

[0336] In some implementations, expanding the guide frame includes expanding the guide frame while the guide frame traverses the valve with an upstream section of the guide frame upstream of the valve and a downstream section of the guide frame downstream of the valve.

[0337] In some implementations, the guide frame has a central section between the upstream section and the downstream section, hi some implementations, expanding the guide frame includes expanding the guide frame such that the central section presses radially against the valve.

[0338] In some implementations, the heart has an atrium upstream of the valve and a ventricle downstream of the valve, hi some implementations, retracting the guide rail into the guide device includes retracting the guide rail into the guide device while the upstream section of the guide frame is positioned within the atrium.

[0339] In some implementations, retracting the guide rail into the guide device includes retracting the guide rail into the guide device while the downstream section of the guide frame is positioned within the ventricle.

[0340] In some implementations, each fastener of the plurality of fasteners extends out from the guide frame at a downstream section of the guide frame.

[0341] In some implementations, drawing the guide rail into the guide device by tightening at least one fastener includes drawing the guide rail into the guide device while the guide rail is within the atrium such that the fastener pulls the guide rail against the upstream surface of the annulus.

[0342] In some implementations, retracting the guide rail into the guide device includes retracting the guide rail into the guide device while the downstream section of the guide frame is positioned within the atrium.

[0343] In some implementations, the method further includes, following retracting the guide rails into the guide device, advancing the guide frame through the valve and into the ventricle until the guide rails abut the annulus.

[0344] In some implementations, expanding the guide frame within the heart includes expanding the guide frame within the atrium, and the method further includes advancing a downstream section of the guide frame into a ventricle before retracting the guide frame into the guide device.

[0345] In some implementations, the method further includes, following positioning the implant along the annulus, contracting the annulus by contracting the implant.

[0346] In some implementations, contracting the implant includes applying tension to a tension member extending through a central channel of the implant.

[0347] In some implementations, applying tension to the tension member includes pulling the tension member using a tensioning tool.

[0348] In some implementations, the method further includes locking the tension to the tension member by locking a stopper to the tension member.

[0349] In some implementations, the method further includes trimming excess tension member proximal to the stopper.

[0350] In some implementations, retracting the guide rail into the guide apparatus includes retracting the guide rail into the guide apparatus while a tension member is extended through an inner lumen of the guide rail.

[0351] In some implementations, advancing the implant along the tissue includes advancing the implant over and along the guide rails such that the guide rails are progressively positioned within the central channel of the implant.

[0352] In some implementations, the method further includes, following advancing the implant along the tissue, withdrawing the guide rails out of the central channel before contracting the implant, leaving the tension member extending through the central channel.

[0353] In some implementations, positioning the implant along the tissue includes advancing the implant along a guide rail.

[0354] In some implementations, the implant includes a helical member defining a plurality of turns, and advancing the implant along the guide rail includes advancing the implant along the guide rail by threading the helical member into the tissue, such that a portion of each turn of the helical member is embedded in the tissue and another portion of each turn is positioned above the surface of the tissue.

[0355] In some implementations, each fastener of the plurality of fasteners defines a loop around the guide rail, and in some implementations, tightening the plurality of fasteners includes, for each fastener of the plurality of fasteners, tightening a respective loop of the fastener.

[0356] In some implementations, retracting the guide rail into the guide device includes (i) retracting the guide rail into the guide device while the guide rail is positioned along the exterior of the guide frame in an upstream section of the guide frame, and / or (ii) retracting the guide rail into the guide device while each fastener of the plurality of fasteners exits the guide frame in a downstream section of the guide frame and extends along the exterior of the guide frame to the guide rail, such that tightening at least one fastener pulls the guide rail toward the downstream section.

[0357] In some implementations, each fastener of the plurality of fasteners is defined by a longitudinal member extending from outside the subject (e.g., a living subject or a simulation) to the heart, the longitudinal member forming a loop. In some implementations, for each fastener of the plurality of fasteners, tightening the respective loop of the fastener includes pulling the longitudinal member from outside the subject (e.g., a living subject or a simulation).

[0358] In some implementations, advancing the guide frame includes advancing the guide frame while each of a plurality of fasteners has a respective exposed length that the fastener extends out of the guide frame to the guide rail, the plurality of fasteners having different exposed lengths from one another.

[0359] In some implementations, the multiple fasteners are arranged in a series around the guide frame, and advancing the guide frame includes advancing the guide frame while each subsequent fastener along the series has a greater exposed length than the preceding fastener.

[0360] In some implementations, retracting the guide rail into the guide device includes, for each fastener of the plurality of fasteners, pulling the longitudinal member from outside the object until a loop of the fastener retracts the guide rail relative to the guide frame.

[0361] In some implementations, the method further includes, for each of the fasteners, opening the loop following positioning the implant along the tissue.

[0362] In some implementations, opening the loop includes unlooping the loop from around the guide rail.

[0363] In some implementations, opening the loop includes unlooping the loop from around the implant.

[0364] In some implementations, retracting the guide rail into the guide device includes retracting the guide rail into the guide device such that a plurality of spacers arranged along the guide frame are sandwiched between the guide rail and the guide frame.

[0365] In some implementations, each of the spacers is defined by a wire, and retracting the guide rail into the guide device includes retracting the guide rail into the guide device such that the wire is sandwiched between the guide rail and the guide frame.

[0366] In some implementations, the method further includes storing a spacer between the guide rail and the guide frame while the guide rail remains within the guide apparatus.

[0367] In some implementations, expanding the guide frame includes expanding the guide frame by actuating a spacer.

[0368] In some implementations, the method further includes compressing the guide frame by actuating a spacer following positioning the implant along the tissue.

[0369] In some embodiments, positioning the implant along the tissue includes spirally advancing the implant along guide rails within the guide device so that the implant is embedded along the surface of the tissue.

[0370] In some implementations, spirally advancing the implant along the guide rail includes spirally advancing the implant along the guide rail by applying a torque to the implant using a driver, wherein a drive head of the driver is reversibly engaged with the implant, the driver having (a) a drive shaft and / or (b) a neck connecting the drive shaft to the drive head.

[0371] In some implementations, both the drive shaft and the neck are formed from a single tube having a first cut pattern along the neck and a second cut pattern cut along the drive shaft, the second cut pattern being different from the first cut pattern, and wherein transluminally advancing the implant into tissue while the implant is reversibly engaged with the driver includes transluminally advancing the implant into tissue along a tortuous path, such that the neck bends in response to the tortuous path facilitated by the first cut pattern.

[0372] In some implementations, the single tube further forms a drive head, and applying torque to the single tube includes applying torque to a drive shaft of the single tube while the drive head of the single tube is engaged with the implant.

[0373] In some implementations, the first cutting pattern segments the neck into separate vertebrae, and advancing the implant transluminally into tissue while the implant is reversibly engaged with a driver so that the neck bends in response to the tortuous path includes advancing the implant transluminally into tissue while the implant is reversibly engaged with a driver so that the vertebrae move relative to one another in response to the tortuous path.

[0374] In some implementations, transluminally advancing the guide frame into the heart includes transluminally advancing the guide frame into the heart while a fixation wire connected to a connector of the guide rail secures the connector in a connected position on the guide frame.

[0375] In some implementations, the connector is an eyelet defined by a distal end portion of the guide rail.

[0376] In some implementations, a securing wire extends out from the guide frame and loops through the eyelet to fasten the connector into a connecting position on the guide frame.

[0377] In some implementations, the method further includes loosening the fixation wire within the heart to facilitate movement of the guide rail away from its connection location and into the guide device before retracting the guide rail into the guide device.

[0378] In some implementations, the method further includes withdrawing the fixation wire from the connector of the guide rail within the heart to decouple the guide rail from the guide frame.

[0379] In some implementations, the connector is disposed at a distal end portion of the guide rail.

[0380] In some implementations, in the guide apparatus, the guide rails are placed around a central section of a guide frame, with the central section being axially disposed between an upstream section of the frame and a downstream section of the frame.

[0381] In some implementations, the connection location is located in the downstream section during advancement of the guide frame into the heart.

[0382] In some implementations, retracting the guide rail into the guide device includes moving the distal end portion toward the central section.

[0383] In some implementations, each of the fasteners is defined by a longitudinal member that extends from the extracorporeal end of the longitudinal member to the guide frame, and the fastener loops around the guide rail.

[0384] In some implementations, the fixed wire prevents the guide rail from sliding out of the fastener upon fastening the connector to the connecting position.

[0385] In some implementations, transluminally advancing the guide frame into the heart includes transluminally advancing the guide frame into the heart while the guide rails are prevented from sliding off the fasteners by the fasteners.

[0386] In some implementations, the multiple fasteners are arranged in series around the guide frame.

[0387] In some implementations, moving the distal end portion toward the central section includes tightening a series of most distal fasteners.

[0388] In some implementations, the method further includes loosening the fixation wire within the heart to facilitate movement of the distal end portion away from the connection location and toward the central section.

[0389] In some implementations, transluminally advancing the guide frame into the heart includes transluminally advancing the guide frame into the heart while the guide rails extend distally through the interior of the guide frame and out of the guide frame at the exit site so that they are positioned along the exterior of the guide frame.

[0390] In some implementations, (i) the guide frame has a longitudinal axis, and / or (ii) expanding the guide frame includes expanding the guide frame radially away from the longitudinal axis.

[0391] In some embodiments, positioning the implant along the tissue includes positioning the implant along the tissue while extending the guide rails distally laterally outward from the guide frame at the exit site so that the guide rails pass through the interior of the guide frame and lie along the exterior of the guide frame.

[0392] In some embodiments, positioning the implant along the tissue includes advancing the implant over and along the guide rails so that the implant passes through the interior of the guide frame, out of the guide frame at the exit site, and along the exterior of the guide frame and tissue.

[0393] In some implementations, retracting the guide rail into the guide device includes (a) retracting the guide rail into the guide device such that, within the interior of the guide frame, the guide rail is confined within a tube that extends to the exterior of the guide frame, and / or (b) outside the guide frame, the guide rail is exposed from the tube.

[0394] In some implementations, advancing the implant over and along the guide rails includes (a) advancing the implant over and along the guide rails within the canal within the guide frame, and / or (b) advancing the implant over and along the guide rails outside the guide frame, such that the implant exits the canal and advances over and along the guide rails exposed from the canal.

[0395] In some implementations, the implant comprises a suture.

[0396] In some implementations, positioning the implant along the tissue includes suturing the suture along the tissue by spirally advancing the suture along a guide rail within a guide device.

[0397] In some implementations, the implant further includes a tension member.

[0398] In some implementations, suturing the suture along the tissue includes suturing the suture along the tissue and the tension member such that the suture defines a spiral along the tissue, the tension member extending along the interior of the spiral.

[0399] In some implementations, the method further includes tensioning the tensioning member so that the tensioning member pulls the suture, thereby adjusting the dimension of the tissue.

[0400] In some implementations, suturing the suture along the tissue includes suturing the suture along the tissue such that the spiral is disposed in a curved path along the tissue, the curved path having a radius of curvature.

[0401] In some implementations, tensioning the tension member to adjust the dimension of the tissue includes tensioning the tension member to adjust the dimension of the tissue by decreasing the radius of curvature of the curved path.

[0402] In some implementations, suturing the suture along the tissue includes suturing the suture along the tissue such that the spiral is disposed in a curved path along the tissue, the curved path having a length.

[0403] In some implementations, tensioning the tension member to adjust the dimension of the tissue includes tensioning the tension member to adjust the dimension of the tissue by decreasing the length of the curved path.

[0404] In some implementations, suturing the suture along the tissue includes suturing the suture along the tissue while the tension member is disposed within the lumen of the guide rail, and the method further includes retracting the guide rail proximally out from the helix, leaving the tension member exposed within the helix.

[0405] In some implementations, suturing the suture along the tissue includes suturing the suture along the tissue using a helical member to helically suture the suture along a guide rail in a guide device, such that the helical member is temporarily sutured along the tissue.

[0406] In some implementations, the method further includes unstitching the helical member from the tissue by helically retracting the helical member, leaving the suture stitched along the tissue with the tension member extending along the interior of the helix.

[0407] In some implementations, suturing the suture along the tissue includes suturing the suture along the tissue using a helical member to helically suture the suture along a guide rail in a guide device, such that the helical member is temporarily sutured along the tissue.

[0408] In some implementations, the method further includes unstitching the helical member from the tissue by helically retracting the helical member, leaving the suture stitched along the tissue.

[0409] In some implementations, suturing the suture along the tissue includes suturing the suture along the tissue while the suture is attached to an exterior of a helical member.

[0410] In some implementations, the method further includes removing the suture from the helical member once the suture has been stitched along the tissue.

[0411] In some implementations, the suture is attached to a distal end portion of the helical member, and suturing the suture along the tissue includes suturing the suture along the tissue by withdrawing the helical member from the tissue, such that the suture is pulled into and along the tissue by withdrawal of the helical member.

[0412] In some implementations, suturing the suture along the tissue includes using a helical member to suturing the suture along the tissue while the suture is along the helical member.

[0413] In some implementations, the helical member defines a plurality of turns, and suturing the suture along the tissue includes threading the helical member and suture into the tissue, thereby suturing the suture along the tissue, such that a portion of each turn of the helical member is embedded in the tissue and another portion of each turn is positioned above the surface of the tissue.

[0414] In some implementations, the helical member is a hollow helical needle defining a channel therethrough, and suturing the suture along the tissue includes threading the helical member along the tissue while the suture is disposed within the channel.

[0415] In some implementations, in the guide apparatus, the guide rails are placed around a central section of a guide frame, with the central section being axially disposed between an upstream section of the frame and a downstream section of the frame.

[0416] In some implementations, expanding the guide frame within the heart includes expanding the guide frame within the heart such that the upstream section is wider than the downstream section.

[0417] In some implementations, expanding the guide frame within the heart includes expanding the guide frame within the heart such that the upstream section is wider than the mid-section.

[0418] In some implementations, expanding the guide frame within the heart includes expanding the guide frame within the heart such that the upstream section protrudes radially outward over the central section.

[0419] In some implementations, positioning the implant along the tissue includes positioning the implant along the tissue while the upstream section projects radially outward across an upstream surface of the tissue.

[0420] In some implementations, the method further includes, following expanding the guide frame, moving the guide frame in a downstream direction until the upstream section protrudes radially outward across the upstream surface of the tissue.

[0421] In some implementations, the method further includes, following expanding the guide frame, moving the guide frame in an upstream direction such that the upstream section passes through and presses against the tissue and protrudes radially outward across the upstream surface of the tissue.

[0422] In some implementations, the guide frame defines an upstream section and a downstream section and a concave waist axially disposed between the upstream and downstream sections.

[0423] In some implementations, expanding the guide frame includes expanding the guide frame by expanding the upstream section and the downstream section larger than the waist, such that the waist has a smaller circumference than both the upstream section and the downstream section.

[0424] In some implementations, positioning the implant along the tissue includes positioning the implant along the tissue while a guide rail is placed around a waist of a guide frame.

[0425] In some implementations, expanding the guide frame within the heart includes expanding the guide frame with tissue such that the tissue is grasped between the upstream section and the downstream section.

[0426] In some implementations, the method further includes, following expanding the guide frame within the heart, positioning the guide frame within the heart such that tissue is sandwiched between the upstream section and the downstream section.

[0427] In some implementations, expanding the guide frame within the heart includes expanding the guide frame within the heart such that an invaginating portion of the guide frame invaginates to form the invagination.

[0428] In some implementations, the distal portion of the control shaft is coupled to the guide frame at an invaginated portion of the guide frame, and transluminally advancing the guide frame into the heart includes transluminally advancing the guide frame into the heart while the guide frame is coupled to the distal portion of the control shaft.

[0429] In some implementations, expanding the guide frame within the heart includes expanding the guide frame outside the body by applying tension to a plurality of actuator wires woven longitudinally along at least a portion of the guide frame.

[0430] In some implementations, in the guide device, the guide rails are positioned around a central section of the guide frame, the central section being axially disposed between the upstream section of the frame and the downstream section of the frame. In some implementations, transluminally advancing the guide frame into the heart includes transluminally advancing the guide frame into the heart using a control shaft coupled to the upstream section of the guide frame. In some implementations, each of the actuator wires extends distally through the interior of the upstream section of the guide frame and interwoven along the downstream section of the guide frame.

[0431] In some implementations, expanding the guide frame within the heart includes expanding a downstream section of the guide frame by tensioning an actuator wire.

[0432] In some implementations, expanding the guide frame within the heart includes expanding the guide frame such that at least a portion of the upstream section is wider than the downstream section.

[0433] In some implementations, expanding the guide frame within the heart includes expanding the guide frame such that at least a portion of the upstream section is wider than the mid-section.

[0434] In some implementations, transluminally advancing the guide frame into the heart includes transluminally advancing the guide frame into the heart using control shafts coupled to a proximal portion of the guide frame, hi some implementations, the method further includes pivoting the guide frame relative to the control shafts by differentially tensioning the actuator wires.

[0435] In some implementations, expanding the guide frame within the heart includes expanding the guide frame by applying balanced tension to the actuator wires.

[0436] In some implementations, in the guide device, the guide rail is positioned around a central section of the guide frame, the central section being axially disposed between the upstream section of the frame and the downstream section of the frame, hi some implementations, expanding the guide frame within the heart includes expanding the guide frame such that a shield disposed around the central section expands along the guide frame.

[0437] In some implementations, expanding the guide frame such that the shield expands with the guide frame includes expanding the guide frame such that the shield elastically expands with the guide frame.

[0438] In some implementations, the shield is a ribbon. In some implementations, transluminally advancing the guide frame into the heart includes transluminally advancing the guide frame into the heart while the ribbon is wrapped around the guide frame.

[0439] In some implementations, expanding the guide frame includes expanding the guide frame so that the ribbon slides over itself in a manner that reduces wrapping around the guide frame.

[0440] In some implementations, the shield is defined by a plurality of ribbons distributed circumferentially around the central section, hi some implementations, transluminally advancing the guide frame into the heart includes transluminally advancing the guide frame into the heart while the ribbons are stacked in a scale-like manner around the central section.

[0441] In some implementations, expanding the guide frame within the heart includes expanding the guide frame within the heart such that the ribbons slide over each other while collectively covering the central section.

[0442] In some implementations, the guide rail defines an external thread, and positioning the implant along the tissue guided by the guide rail includes threadably advancing the implant along the external thread.

[0443] In some implementations, the external threads define a groove. In some implementations, the implant includes a helical member defining a plurality of turns. In some implementations, threading and advancing the implant along the external threads includes threading and advancing the implant along the external threads while the helical member is recessed within the groove.

[0444] In some implementations, positioning the implant along the tissue guided by the guide rail includes advancing the implant along the guide rail while the rider shields the guide frame from the tip of the implant, while the tip of the implant pushes the rider, which is slidably mounted to the guide rail, along the guide rail.

[0445] In some implementations, the implant includes a helical member defining a sharp tip at its tip, hi some implementations, advancing the implant along the guide rail includes advancing the implant along the guide rail while a lobe of the rider remains disposed between the tip and the guide frame, thereby shielding the guide frame from the sharp tip.

[0446] According to some implementations, the system and / or device (which may be used in a heart, e.g., a live subject or a simulated heart) includes an implant and / or a delivery assembly. In some implementations, the delivery assembly may include a guide assembly and / or a driver.

[0447] In some implementations, the guide assembly includes a guide rail having a leading segment, and the implant is mounted on the guide rail.

[0448] In some implementations, the driver can be engaged with or configured to engage with the implant.

[0449] In some implementations, the delivery assembly can be configured to repeatedly secure the implant along the tissue by (i) distally advancing the leading segment out from the distal end of the implant to a position along the tissue extension, and (ii) a driver threading the implant into the tissue along the extension, thereby securing the leading segment along the tissue extension.

[0450] In some implementations, the implant is sterilized, in some implementations, the guide assembly is sterilized, in some implementations, the guide rail is sterilized, in some implementations, the driver is sterilized.

[0451] In some implementations, the leading segment includes one or more imaging markers to facilitate determining the location of the leading segment within the heart.

[0452] In some implementations, the system further includes a catheter within which the delivery assembly and implant are transluminally advanceable to the heart.

[0453] In some implementations, the driver is configured to screw the implant into tissue along the extension by threading the implant over and along the leading segment while the leading segment remains in position along the extension.

[0454] In some implementations, the guide assembly is configured to slide the guide rail proximally out of the implant.

[0455] In some implementations, the delivery assembly is configured to manipulate the leading segment into alignment with the tissue extension.

[0456] In some implementations, the leading segment comprises a magnetic material. In some implementations, the system further comprises an electromagnet advanceable to the heart and configured to operate to align the leading segment.

[0457] In some implementations, the system includes an electromagnet tool configured to include an electromagnet and to excite the electromagnet in a manner that operates to align the leading segment by magnetically attracting the leading segment toward the electromagnet.

[0458] In some implementations, the system includes an electromagnet tool configured to include an electromagnet and to excite the electromagnet in a manner that operates to align the leading segment by magnetically repelling the leading segment away from the electromagnet.

[0459] In some implementations, the system includes an electromagnetic tool that includes an electromagnet and is configured to advance the electromagnet into an atrium of the heart and manipulate the leading segment from the atrium.

[0460] In some implementations, the system includes an electromagnetic tool that includes an electromagnet and is configured to advance the electromagnet into a ventricle of the heart and manipulate the leading segment from the ventricle.

[0461] In some implementations, the system includes an electromagnetic tool that includes an electromagnet and is configured to advance the electromagnet into a coronary vessel of the heart and manipulate the leading segment from the coronary vessel.

[0462] In some implementations, the leading segment comprises a shape memory alloy, and the curvature of the leading segment is adjustable by heating the leading segment.

[0463] In some implementations, the guide rail includes a plurality of heating elements distributed along the leading segment and actuatable to electrically heat the leading segment.

[0464] In some implementations, each of the heating elements is actuatable independently of the other heating elements to adjust the curvature of only the corresponding portion of the leading segment.

[0465] In some implementations, the leading segment includes an outer tube and / or an inner shaft.

[0466] In some implementations, the inner shaft is disposed inside the outer tube, hi some implementations, the inner shaft is axially slidable relative to the outer tube.

[0467] In some implementations, the inner shaft has a different resting curvature relative to the outer tube.

[0468] In some implementations, the inner shaft has a greater rest curvature than the outer tube.In some implementations, the outer tube has a greater rest curvature than the inner shaft.

[0469] In some implementations, the leading segment includes one or more electrodes electrically connected to the extracorporeal portion of the delivery assembly.

[0470] In some implementations, the system further includes a data processing system electrically connectable to one or more electrodes by being connected to terminals on the extracorporeal portion of the delivery assembly.

[0471] In some implementations, the data processing system is configured to receive electrical signals from one or more electrodes and / or to provide an output in response to the electrical signals that is indicative of the intracardiac location of the leading segment.

[0472] In some implementations, the location includes a proximity of the leading segment to the tissue surface. In some implementations, the data processing system is configured to provide an output indicative of the proximity of the leading segment to the tissue surface in response to the electrical signal.

[0473] In some implementations, the location includes contact of the leading segment with the tissue surface. In some implementations, the data processing system is configured to provide an output indicative of contact of the leading segment with the tissue surface in response to the electrical signal.

[0474] In some implementations, the location is a location along the atrioventricular axis of the heart. In some implementations, the data processing system is configured to provide an output indicative of the location along the atrioventricular axis in response to the electrical signal.

[0475] In some implementations, the output is indicative of the type of tissue that the leading segment is contacting. In some implementations, the data processing system is configured to provide an output indicative of the type of tissue in response to the electrical signal.

[0476] In some implementations, the electrical signal is an ECG signal. In some implementations, the data processing system is configured to receive the ECG signal.

[0477] In some implementations, the electrical signal is an exogenous signal. hi some implementations, the data processing system is configured to receive the exogenous signal.

[0478] In some implementations, the data processing system is configured to determine bioimpedance based on the exogenous signal. In some implementations, the data processing system is configured to provide an output in response to the bioimpedance.

[0479] In some implementations, the one or more electrodes is a plurality of electrodes, hi some implementations, the data processing system is configured to drive an exogenous signal between at least two of the electrodes.

[0480] In some implementations, the implant includes one or more electrodes electrically connected to the extracorporeal portion of the delivery assembly.

[0481] In some implementations, the one or more electrodes are electrically connected to an external portion of the driver.

[0482] In some implementations, the system further includes a data processing system electrically connectable to one or more electrodes by being connected to terminals on the extracorporeal portion of the delivery assembly.

[0483] In some implementations, the data processing system is configured to receive electrical signals from one or more electrodes.

[0484] In some implementations, the data processing system is configured to provide an output indicative of the position of the implant within the heart in response to the electrical signal.

[0485] In some implementations, the location includes a proximity of the implant to the tissue surface. In some implementations, the data processing system is configured to provide an output indicative of the proximity of the implant to the tissue surface in response to the electrical signal.

[0486] In some implementations, the position includes an orientation of the implant relative to the tissue. In some implementations, the data processing system is configured to provide an output indicative of the orientation of the implant relative to the tissue in response to the electrical signal.

[0487] In some implementations, the location includes a depth of the implant within the tissue. In some implementations, the data processing system is configured to provide an output indicative of the depth of the implant within the tissue in response to the electrical signal.

[0488] In some implementations, the location is a location along the atrioventricular axis of the heart. In some implementations, the data processing system is configured to provide an output indicative of the location along the atrioventricular axis in response to the electrical signal.

[0489] In some implementations, the output is indicative of the type of tissue the implant is in contact with. In some implementations, the data processing system is configured to provide an output indicative of the type of tissue in response to the electrical signal.

[0490] In some implementations, the electrical signal is an ECG signal. In some implementations, the data processing system is configured to receive the ECG signal.

[0491] In some implementations, the electrical signal is an exogenous signal. hi some implementations, the data processing system is configured to receive the exogenous signal.

[0492] In some implementations, the data processing system is configured to determine bioimpedance based on the exogenous signal. In some implementations, the data processing system is configured to provide an output in response to the bioimpedance.

[0493] In some implementations, the one or more electrodes is a plurality of electrodes, hi some implementations, the data processing system is configured to drive an exogenous signal between at least two of the electrodes.

[0494] In some implementations, the implant includes a helical member defining a plurality of turns and surrounding a central channel.

[0495] In some implementations, the implant includes a head coupled to the helical member, and a driver is configured to engage the head of the implant and apply torque to the head to screw the implant into tissue.

[0496] In some implementations, the helical member defines a sharp tip.

[0497] In some implementations, the implant further includes a tension member disposed within the central channel and configured to axially contract the helical member when tension is applied to the tension member.

[0498] In some implementations, the tension member extends along a lumen defined by the guide rail.

[0499] According to some implementations, a method for implanting an implant along tissue (which may be, for example, tissue of a living subject or a simulated heart) includes positioning a leading segment of a guide rail along a first extension of the tissue and / or securing the leading segment to the first extension by screwing the implant into the tissue along the first extension.

[0500] In some implementations, the method further includes thereafter advancing a leading segment of the guide rail distally out of the distal end of the implant and along the second stretch of tissue.

[0501] In some implementations, the method further includes securing the leading segment to the second extension by threading the implant into tissue along the second extension.

[0502] In some implementations, the method further includes sterilizing the implant.

[0503] In some implementations, the method further includes sterilizing the guide rail.

[0504] In some implementations, for each of the first extension portion and the second extension portion, screwing the implant into tissue along the extension portion includes screwing the implant over and along the leading segment while the leading segment is positioned along the extension portion.

[0505] In some implementations, screwing the implant into tissue along the first extension and the second extension includes screwing the implant into tissue in a manner such that the implant is screwed incrementally around the guide rail.

[0506] In some implementations, the method further includes, following threading the implant into the tissue along the second extension, retracting the guide rail out from the implant by sliding the guide rail proximally through the implant so that the implant remains implanted in the heart.

[0507] In some implementations, the implant includes a helical member defining a plurality of turns and surrounding a central channel.

[0508] In some implementations, screwing the implant into tissue along the first extension and the second extension includes (i) screwing the helical member into tissue such that a portion of each turn of the helical member is embedded in the tissue and another portion of each turn is positioned above the surface of the tissue, and / or (ii) the leading segment is positioned within the central channel.

[0509] In some implementations, the helical member defines a sharpened distal tip, and threading the helical member into tissue includes threading the helical member into tissue facilitated by the sharpened distal tip.

[0510] In some implementations, the implant further includes a tension member disposed within the central channel, and the method further includes applying tension to the tension member to reduce the circumference of the tissue following threading the implant into the tissue along the second extension.

[0511] In some implementations, the implant includes a head reversibly engageable by a driver, and screwing the helical member into tissue includes screwing the helical member into tissue while the driver is engaged with the head using the driver.

[0512] In some implementations, the method further includes transluminally advancing the guide rail into the heart while housed within the catheter.

[0513] In some implementations, positioning the leading segment along the first extension includes positioning the leading segment along the first extension by exposing the leading segment out of the catheter.

[0514] In some implementations, the method further includes, for each of the first extension and the second extension, determining an intracardiac position of the leading segment while the leading segment remains positioned along the extension before securing the leading segment to the extension.

[0515] In some implementations, determining the intracardiac location of the leading segment includes determining the intracardiac location of the leading segment by imaging the leading segment within the heart.

[0516] In some implementations, imaging the leading segment within the heart includes imaging the leading segment within the heart using fluoroscopy.

[0517] In some implementations, determining the intracardiac location of the leading segment includes determining the intracardiac location of the leading segment by sensing electrical signals using the leading segment.

[0518] In some implementations, the electrical signal is an intrinsic electrical signal, and sensing the electrical signal includes sensing the intrinsic electrical signal.

[0519] In some implementations, the intrinsic electrical signal is an ECG signal, and sensing the intrinsic electrical signal includes sensing an ECG signal.

[0520] In some implementations, the electrical signal is an exogenous electrical signal, and sensing the electrical signal includes sensing the exogenous electrical signal.

[0521] In some implementations, the method further includes applying an exogenous electrical signal to a subject (e.g., a living subject or a simulation).

[0522] In some implementations, sensing the exogenous electrical signal includes sensing bioimpedance.

[0523] In some implementations, following positioning the leading segment along the first extension and prior to screwing the implant into tissue along the first extension, the method further includes (i) receiving electrophysiological signals generated by the heart indicative of the position of the leading segment within the heart, and / or (ii) determining the position of the leading segment within the heart in response to the received signals.

[0524] In some implementations, determining the position of the leading segment within the heart includes determining the position of the leading segment along an atrioventricular axis of the heart.

[0525] In some implementations, determining the position of the leading segment within the heart in response to the received signal includes determining whether there is contact between the leading segment and tissue in response to the received signal.

[0526] In some implementations, the leading segment defines an electrode, and receiving an electrophysiological signal generated by the heart includes receiving the electrophysiological signal generated by the heart via the electrode.

[0527] In some implementations, the electrode is a ring electrode positioned around the leading segment, and receiving the electrophysiological signal generated by the heart includes receiving the electrophysiological signal generated by the heart via the ring electrode.

[0528] In some implementations, following positioning the leading segment along the first extension and prior to screwing the implant into tissue along the first extension, the method further includes (i) receiving electrophysiological signals generated by the heart indicative of the position of the implant within the heart, and / or (ii) determining the position of the implant within the heart in response to the received signals.

[0529] In some implementations, determining the position of the implant within the heart includes determining the position of the implant along the atrioventricular axis of the heart.

[0530] In some implementations, the implant includes a helical member defining a plurality of turns and surrounding a central channel, hi some implementations, threading the implant into tissue along the first extension and the second extension includes threading the helical member into tissue such that a portion of each turn of the helical member is embedded in the tissue and another portion of each turn is positioned above a surface of the tissue.

[0531] In some implementations, receiving the electrophysiological signal generated by the heart includes receiving the electrophysiological signal generated by the heart via an electrode mounted on a turn of the helical member.

[0532] In some implementations, the method includes determining a position of the implant within the heart in response to the received signals, and determining whether the electrodes are positioned within tissue in response to the received signals.

[0533] In some implementations, the implant defines a conductive portion, and receiving the electrophysiological signal generated by the heart includes receiving the electrophysiological signal generated by the heart via the conductive portion.

[0534] In some implementations, positioning the leading segment along the first extension includes manipulating the leading segment into a desired alignment with the first extension.

[0535] In some implementations, the leading segment includes a magnetic material, and manipulating the leading segment includes manipulating the leading segment using an electromagnet.

[0536] In some implementations, manipulating the leading segment using an electromagnet includes magnetically repelling the leading segment from the electromagnet.

[0537] In some implementations, manipulating the leading segment using an electromagnet includes magnetically attracting the leading segment towards the electromagnet.

[0538] In some implementations, the electromagnet is a first electromagnet in a series of electromagnets, and manipulating the leading segment includes manipulating the leading segment using a series of electromagnets positioned at various locations within the heart.

[0539] In some implementations, the method further includes positioning an electromagnet within an atrium of the heart, and manipulating the leading segment using the electromagnet includes manipulating the leading segment using the electromagnet while the electromagnet is positioned within the atrium.

[0540] In some implementations, the method further includes positioning an electromagnet within a ventricle of the heart, and manipulating the leading segment using the electromagnet includes manipulating the leading segment using the electromagnet while the electromagnet is positioned within the ventricle.

[0541] In some implementations, the method further includes positioning an electromagnet within a coronary vessel of the heart adjacent to the first extension, and manipulating the leading segment using the electromagnet includes manipulating the leading segment using the electromagnet while the electromagnet is positioned within the coronary vessel.

[0542] In some implementations, the method further includes advancing the electromagnet along the coronary vessel so that the electromagnet is adjacent to the second extension, and using the electromagnet to position the leading segment along the second extension that manipulates the leading segment into desired alignment with the second extension.

[0543] In some implementations, manipulating the leading segment into the desired alignment with the tissue includes adjusting the curvature of the leading segment by electrically heating the leading segment.

[0544] In some implementations, the guide rail includes a plurality of heating elements distributed along the leading segment, and electrically heating the leading segment includes electrically heating the leading segment by activating one or more of the plurality of heating elements.

[0545] In some implementations, adjusting the curvature of the leading segment includes adjusting the curvature of only a portion of the leading segment by heating only a portion of the leading segment by activating only a subset of the multiple heating elements.

[0546] In some implementations, the leading segment includes an outer tube and / or an inner shaft, hi some implementations, the inner shaft is disposed inside the outer tube.

[0547] In some implementations, the inner shaft has a different resting curvature relative to the outer tube.

[0548] In some implementations, the method includes manipulating the leading segment to a desired alignment relative to the tissue, and adjusting the curvature of the leading segment by sliding the inner shaft axially relative to the outer tube.

[0549] In some implementations, the outer tube has a greater static curvature than the inner shaft, and adjusting the curvature of the leading segment includes decreasing the curvature of the leading segment by axially sliding the inner shaft distally relative to the outer tube.

[0550] In some implementations, the inner shaft has a greater static curvature than the outer tube, and adjusting the curvature of the leading segment includes increasing the curvature of the leading segment by axially sliding the inner shaft distally relative to the outer tube.

[0551] According to some implementations, the method (which may be used, e.g., in a live subject's or a simulated heart) includes transluminally advancing a guide frame into a heart (e.g., a simulated heart) while the guide frame is secured to a guide rail via a plurality of fasteners extending out from the guide frame to the guide rail. In some implementations, the guide frame may be expanded within the heart.

[0552] In some implementations, the guide rail can be drawn into the guide arrangement around at least a portion of the guide frame by tightening at least one of the plurality of fasteners.

[0553] In some implementations, the implant can be positioned along the tissue (e.g., simulated tissue) of the heart (e.g., simulated heart) guided by the guide rails while the guide rails remain within the guide device.

[0554] According to some implementations, a method of implanting an implant along cardiac tissue (e.g., along simulated tissue) (e.g., of a living subject or a simulated heart) includes positioning a leading segment of a guide rail along a first extension of the tissue (e.g., living tissue, simulated tissue, etc.) and / or securing the leading segment to the first extension by screwing the implant into the tissue along the first extension.

[0555] In some implementations, the method may then further include advancing the leading segment of the guide rail distally out from the distal end of the implant and along a second extension of tissue (e.g., live tissue, simulated tissue, etc.).

[0556] In some implementations, the method may further include securing the leading segment to the second extension by threading the implant into tissue along the second extension.

[0557] According to some implementations, the system and / or device (which may be used, for example, in a living subject's or a simulated heart) includes a guide assembly and includes a guide frame that is transluminally advanceable into the heart and deployable at a site within the heart.

[0558] In some implementations, the system may further include one or more fasteners secured to the guide frame.

[0559] In some implementations, the system may further include a guide rail that is threaded through the fastener and positionable around the guide frame, such that the guide rail is positioned along the guide frame within the guide device, and the guide rail has electrodes in series disposed along the guide rail.

[0560] In some implementations, the system may further include a data processing system electrically connected to each electrode in the series and configured to (i) receive an electrical signal from each electrode in the series, and / or (ii) provide an output in response to the electrical signal, the output indicating the position of the guide rail within the heart.

[0561] In some implementations, the electrodes are radiopaque.

[0562] In some implementations, each electrode in the series is electrically connected to an extracorporeal portion of the guide assembly. In some implementations, the extracorporeal portion includes electrical terminals. In some implementations, a data processing system is electrically connected to the electrodes by being electrically connected to the terminals.

[0563] In some implementations, each of the electrodes in the series is a ring electrode positioned around the guide rail.

[0564] In some implementations, the position includes a proximity of the guide rail to the tissue surface. hi some implementations, the data processing system is configured to provide an output indicative of the proximity of the guide rail to the tissue surface in response to the electrical signal.

[0565] In some implementations, the position includes contact of the guide rail with the tissue surface. In some implementations, the data processing system is configured to provide an output indicative of contact of the guide rail with the tissue surface in response to the electrical signal.

[0566] In some implementations, the position includes verification of contact between the guide rail and tissue of the heart annulus. In some implementations, the data processing system is configured to provide an output indicative of verification of contact between the guide rail and tissue of the heart annulus in response to the electrical signal.

[0567] In some implementations, the position is a position along the atrioventricular axis of the heart. In some implementations, the data processing system is configured to provide an output in response to the electrical signal that is indicative of the position of the guide rail along the atrioventricular axis.

[0568] In some implementations, the output is indicative of the type of tissue that the guide rail is in contact with. In some implementations, the data processing system is configured to provide an output indicative of the type of tissue in response to the electrical signal.

[0569] In some implementations, the electrical signal is an ECG signal. In some implementations, the data processing system is configured to receive the ECG signal.

[0570] In some implementations, the guide frame is expandable within the heart toward the expanded state in a manner that retracts the guide rails along the guide frame and into the guide device.

[0571] In some implementations, the electrical signal is an exogenous signal. hi some implementations, the data processing system is configured to receive the exogenous signal.

[0572] In some implementations, the data processing system is configured to determine the bioimpedance of the tissue based on the exogenous signal, hi some implementations, the data processing system is configured to provide an output in response to the bioimpedance.

[0573] In some implementations, the data processing system is configured to drive an exogenous signal between at least two of the electrodes in series.

[0574] In some implementations, the fasteners are arranged in a series around the guide frame, and the guide assembly has a delivery state in which (i) the guide assembly is transluminally advanceable to the heart, and / or (ii) each subsequent fastener along the series has a greater exposed length than the preceding fastener.

[0575] In some implementations, the fasteners can be tightened intracardially from a proximal extracorporeal portion of the guide assembly in response to an output in a manner that draws the guide rails along the guide frame and into the guide device.

[0576] In some implementations, the system further includes an implant and a driver configured to advance the implant along the guide rail while the guide rail is within the guide apparatus.

[0577] In some implementations, the implant is a helical member.

[0578] According to some implementations, the method (which may be used, for example, in a living subject's or a simulated heart) includes transluminally advancing a guide frame and guide rails into the heart.

[0579] In some implementations, the method may further include expanding the guide frame within the heart.

[0580] In some implementations, the method may further include determining a position of the guide rail within the heart in response to the electrical signal detected through the guide rail.

[0581] In some implementations, the method may further include, in response to the determination, retracting the guide rail into the guide apparatus around at least a portion of the guide frame.

[0582] In some implementations, the method further includes positioning the implant along the tissue of the heart guided by the guide rail while the guide rail remains within the guide device.

[0583] In some implementations, the method further includes adjusting a size of the implant in response to the electrical signal before positioning the implant along the tissue.

[0584] In some implementations, transluminally advancing the guide frame and guide rail into the heart includes transluminally advancing the guide frame and guide rail into the heart while the guide frame is secured to the guide rail via a plurality of fasteners, each fastener of the plurality of fasteners extending out from the guide frame and securing the guide rail within a loop of the fastener.

[0585] In some implementations, retracting the guide rail into the guide apparatus includes, for each fastener of the plurality of fasteners, pulling the fastener from outside the subject (e.g., a live subject or a simulation) in response to the determination until a loop of the fastener retracts the guide rail against the guide frame.

[0586] In some implementations, the guide rail has a series of electrodes spaced therealong. In some implementations, the electrical signal is a first electrical signal of a plurality of electrical signals, each of the plurality of electrical signals being detected by a corresponding electrode in the series. In some implementations, determining the position of the guide rail includes determining the position of the guide rail in response to the plurality of electrical signals.

[0587] In some implementations, the first electrical signal is detected by a first electrode in series, and retracting the guide rail into the guide device includes retracting the guide rail into the guide device by pulling (i) a first fastener of the plurality of fasteners by a first amount in response to the first electrical signal, and / or (ii) a second fastener of the plurality of fasteners by a second amount in response to a second electrical signal detected by a second electrode in series.

[0588] In some implementations, pulling a first fastener of the plurality of fasteners includes pulling the first fastener of the plurality of fasteners until a first electrical signal indicates tissue contact between the first electrode and the tissue, hi some implementations, pulling a second fastener of the plurality of fasteners includes pulling a second fastener of the plurality of fasteners until a second electrical signal indicates tissue contact between the second electrode and the tissue.

[0589] In some implementations, retracting the guide rail into the guide device includes determining that (i) an electrical signal received from a first portion of the guide rail indicates the presence of tissue contact, and (ii) an electrical signal received from a second portion of the guide rail indicates the absence of tissue contact.

[0590] In some implementations, in the guide rail guide device, the first portion is distal to the second portion.

[0591] In some implementations, the second portion of the guide rail guide device is positioned within the heart upstream of the first portion.

[0592] According to some implementations, a method usable on a (e.g., live or simulated) heart includes transluminally advancing a replacement heart valve into the heart, the replacement heart valve having a series of electrodes disposed along its circumference.

[0593] In some implementations, the method may further include expanding the replacement heart valve within the heart.

[0594] In some implementations, the method may further include receiving an output indicative of the electrical signal detected via the series of electrodes.

[0595] In some implementations, the method may further include positioning a replacement heart valve within the heart in response to the indication.

[0596] According to some implementations, a system and / or device (which may be used, for example, in a living subject's or a simulated heart) includes a delivery assembly and a replacement heart valve having an array of electrodes spaced along its circumference and transluminally advanceable through the delivery assembly into the heart.

[0597] In some implementations, the system may further include a data processing system electrically connected to each electrode in the series via the delivery assembly and configured to (i) receive electrical signals from the electrodes in the series and / or (ii) provide an output in response to the electrical signals that indicates the position of the replacement heart valve within the heart.

[0598] In some implementations, the electrical signal is a first electrical signal of a plurality of electrical signals, each of the plurality of electrical signals being detected by a corresponding electrode in series, and the data processing system is configured to provide an output in response to the plurality of electrical signals.

[0599] In some implementations, the location includes proximity of the perimeter to the tissue surface. In some implementations, the data processing system is configured to provide an output indicative of the proximity of the perimeter to the tissue surface in response to the electrical signal.

[0600] In some implementations, the location includes contact of the perimeter with the tissue surface. In some implementations, the data processing system is configured to provide an output indicative of contact of the perimeter with the tissue surface in response to the electrical signal.

[0601] In some implementations, the location includes verification of contact between the periphery and tissue of the heart annulus. In some implementations, the data processing system is configured to provide an output indicative of the verification of contact between the periphery and tissue of the heart annulus in response to the electrical signal.

[0602] In some implementations, the location indicates a circumferential height within a valve of the heart. In some implementations, the data processing system is configured to provide an output indicative of a circumferential height within the valve of the heart in response to the electrical signal.

[0603] In some implementations, the output is indicative of the type of tissue that the perimeter is in contact with. In some implementations, the data processing system is configured to provide an output indicative of the type of tissue in response to the electrical signal.

[0604] In some implementations, the electrical signal is an ECG signal. In some implementations, the data processing system is configured to receive the ECG signal.

[0605] In some implementations, the electrical signal is an exogenous signal. hi some implementations, the data processing system is configured to receive the exogenous signal.

[0606] In some implementations, the data processing system is configured to determine the bioimpedance of the tissue based on the exogenous signal, hi some implementations, the data processing system is configured to provide an output in response to the bioimpedance.

[0607] In some implementations, the data processing system is configured to drive an exogenous signal between at least two of the electrodes in series.

[0608] In some implementations, the replacement heart valve has a frame defining a plurality of struts.

[0609] In some implementations, the frame defines a waist adapted to be circumferentially positioned within the annulus of the heart, hi some implementations, the periphery is the periphery of the waist, and the series of electrodes are spaced apart therealong.

[0610] According to some implementations, the system (eg, may be used in a living subject or simulated tissue) includes a tissue anchor and / or a driver.

[0611] In some implementations, the tissue anchor includes a helical tissue-engaging element and an anchor head.

[0612] In some implementations, the driver is configured to transluminally thread the tissue engaging element into tissue by applying torque to the anchor head, the driver comprising: (a) a drive head configured to reversibly engage the anchor head at a distal end of the driver; (b) a drive shaft configured to receive torque from a proximal end of the driver and defining a first pattern of cuts including a plurality of transverse slits along the drive shaft and bendable via deformation of the tube and the slits; and / or (c) a neck connecting the drive shaft to the drive head in a manner to transmit torque from the drive shaft to the drive head, the neck being formed from a single tube defining (i) a second pattern of cuts that segment the neck into separate vertebrae and / or (ii) bendable via movement of the vertebrae relative to one another.

[0613] According to some implementations, a system for use in cardiac tissue, the system including an implant and / or a delivery assembly.

[0614] In some implementations, the delivery assembly includes a guide assembly and / or a driver.

[0615] In some implementations, the guide assembly includes a guide frame and guide rails at a distal portion of the guide assembly, and the guide assembly has (i) a delivery state in which the distal portion is transluminally advanceable into the heart, and / or (ii) is transitionable into the heart to a guide state in which the guide rails are within the guide device, extending (a) through the interior of the guide frame and exiting the guide frame at an exit site, and / or (b) from the exit site around the exterior of the guide frame.

[0616] In some implementations, the driver is configured to advance the implant along guide rails within the guide device.

[0617] In some implementations, the delivery assembly is configured to facilitate the guide assembly withdrawing the guide rails and guide frame from the heart while the implant remains within the heart.

[0618] In some implementations, the guide assembly includes a plurality of fasteners that can be tightened within the heart from a proximal extracorporeal portion of the delivery assembly in a manner that draws the guide rails into the guide device around at least a portion of the exterior of the guide frame.

[0619] In some implementations, the tissue is tissue of the annulus of a heart valve.

[0620] In some implementations, the driver is configured to advance the implant along the guide rail within the guide device while the guide rail is positioned along the valve annulus.

[0621] In some implementations, the driver is configured to advance the implant along the guide rail by threading the implant into and along the atrial surface of the annulus tissue.

[0622] In some implementations, the system includes a flexible helical member that defines a plurality of turns.

[0623] In some implementations, the guide assembly is configured to position the guide rail within the guide device along the surface of the tissue.

[0624] In some implementations, the driver is configured to anchor the implant along the tissue by threading the helical member along the guide rail and the tissue while the guide rail in the guide device is positioned along the surface of the tissue, such that a portion of each turn of the helical member is embedded in the tissue and another portion of each turn is positioned above the surface of the tissue.

[0625] In some implementations, the implant includes a helical member.

[0626] In some implementations, the implant comprises a suture.

[0627] In some implementations, the driver is configured to thread the suture along the tissue by threading a helical member along the guide rail and tissue such that the suture defines multiple turns while the guide rail in the guide device is positioned along the surface of the tissue.

[0628] In some implementations, the implant includes a tensioning member extending through each of the turns of the suture, hi some implementations, the system further includes a tensioning tool adapted to adjust the dimension of the tissue by applying tension to the tensioning member such that the tensioning member pulls each of the turns of the suture.

[0629] In some implementations, the guide frame has a longitudinal axis and is expandable within the heart toward an expanded state by expanding radially away from the longitudinal axis.

[0630] In some implementations, in the guide device, the guide rails extend distally through the interior of the guide frame and out of the guide frame at the exit site so as to curve around the exterior and longitudinal axis of the guide frame.

[0631] In some implementations, the delivery assembly further includes a tube, with the guide rail extending through the tube.

[0632] In some implementations, the guide device has: (a) a tube extending distally through the interior of the guide frame and out of the guide frame at an exit site; (b) within the tube, a guide rail extending distally through the interior of the guide frame and out of the guide frame at an exit site; and / or (c) outside the guide frame, the guide rail exits the tube and lies exposed around the exterior of the guide frame.

[0633] In some implementations, the tube has a distal section that exits the guide frame at an exit site, and at least the distal section of the tube is a flexible sleeve.

[0634] In some implementations, the guide assembly includes a control shaft, the distal end of which is attached to the guide frame in a manner that facilitates transluminal control of the guide frame via the control shaft.

[0635] In some implementations, the guide rail extends distally from the control shaft into the interior of the guide frame.

[0636] In some implementations, the guide rail extends from its extracorporeal portion distally through the control shaft to the interior of the guide frame.

[0637] In some implementations, the implant can be advanced transluminally (a) over and along the guide rails, distally through the control shaft, and / or (b) out of the control shaft, over and along the guide rails, into the interior of the guide frame, exiting the guide frame at an exit site, and along the guide rails to and toward the tissue.

[0638] According to some implementations, a device (eg, that may be used in a living subject or a simulated tissue) includes an implant and / or a driver.

[0639] In some implementations, the implant includes a helical member defining (i) a sharp distal tip and / or (ii) a proximal end, wherein the helical member has a greater thickness toward the proximal end than toward the distal tip.

[0640] In some implementations, the driver is configured to screw the implant along the tissue by applying a torque to the proximal end of the helical member such that a portion of each turn of the helical member is embedded in the tissue and another portion of each turn is positioned above the surface of the tissue.

[0641] According to some implementations, a method (which may be used, for example, in a living subject or in a simulated tissue) includes transluminally positioning a guide rail along a surface of the tissue.

[0642] In some implementations, the method further includes suturing the suture along the tissue by using a flexible helical member and helically advancing the helical member along the guide rail, such that the suture defines a series of turns along the tissue, with a portion of each turn embedded within the tissue and another portion of each turn above the surface of the tissue.

[0643] In some implementations, the method further includes thereafter adjusting the dimension of the tissue using a tensioning member positioned along the surface of the tissue and extending through each of the turns of the suture by tensioning the tensioning member such that the tensioning member pulls on each of the turns of the suture.

[0644] In some implementations, suturing the suture along the tissue includes suturing the suture along the tissue while a tension member is positioned along the lumen of the guide rail, and the method further includes retracting the guide rail proximally from the series of turns, leaving the tension member exposed within the series of turns.

[0645] In some implementations, suturing the suture along the tissue includes using a helical member to suturing the suture along the tissue while the suture is along the helical member.

[0646] In some implementations, the helical member is a hollow helical needle defining a channel therethrough, and suturing the suture along the tissue includes threading the helical member along the tissue while the suture is disposed within the channel.

[0647] In some implementations, adjusting the dimension of the tissue using the tensioning member includes tensioning the tensioning member such that the tensioning member reshapes each turn in the series of turns.

[0648] In some implementations, tensioning the tension member such that the tension member reshapes each turn of the series of turns includes tensioning the tension member such that each turn of the series of turns transitions from a more rounded shape to a more elliptical shape.

[0649] In some implementations, the tissue is tissue of the annulus of a heart valve, the annulus surrounding the valve orifice.

[0650] In some implementations, suturing the suture along the tissue includes suturing the suture along the guide rail and into and along the tissue of the annulus.

[0651] In some implementations, adjusting the dimension of the tissue using the tensioning member includes tensioning the tensioning member to reduce the dimension of the annulus.

[0652] In some implementations, adjusting the dimension of the tissue using the tensioning member includes tensioning the tensioning member such that the tensioning member is suspended above the valve orifice.

[0653] In some implementations, suturing the suture along the tissue includes suturing the suture along the tissue while the suture is attached to an exterior of a helical member.

[0654] In some implementations, the method further includes removing the suture from the helical member once the suture has been stitched along the tissue.

[0655] In some implementations, the suture is attached to a distal end portion of the helical member, and suturing the suture along the tissue includes suturing the suture along the tissue by withdrawing the helical member from the tissue, such that the suture is pulled into and along the tissue by withdrawal of the helical member.

[0656] In some implementations, suturing the suture along the tissue includes suturing the suture along the tissue such that a helical member is temporarily sutured along the tissue.

[0657] In some implementations, the method further includes unstitching the helical member from the tissue by helically retracting the helical member, leaving the suture stitched along the tissue with the tension member extending along the interior of the series of turns.

[0658] In some implementations, suturing the suture along the tissue and the tensioning member includes suturing the suture along the tissue and the tensioning member such that the tensioning member extends along the interior of a series of turns.

[0659] In some implementations, suturing the suture along the tissue includes suturing the suture along the tissue such that the suture defines a spiral disposed in a curved path along the tissue, the curved path having a radius of curvature.

[0660] In some implementations, adjusting the dimension of the tissue using the tensioning member includes applying tension to the tensioning member to adjust the dimension of the tissue by reducing the radius of curvature of the curved path.

[0661] In some implementations, suturing the suture along the tissue includes suturing the suture along the tissue such that the suture defines a spiral disposed in a curved path along the tissue, the curved path having a length.

[0662] In some implementations, adjusting the dimension of the tissue using the tensioning member includes applying tension to the tensioning member to adjust the dimension of the tissue by reducing the length of the curved path.

[0663] According to some implementations, a system (which may be used in real or simulated tissue, for example, in a living subject or a simulated heart) includes a suture, a tensioning member, and / or a delivery assembly.

[0664] In some implementations, the delivery assembly includes a guide assembly including a guide rail, the guide assembly configured to transluminally advance the guide rail into the heart and position the guide rail within the guide device along the surface of the tissue.

[0665] In some implementations, the delivery assembly includes a flexible helical member.

[0666] In some implementations, the delivery assembly includes a driver configured to suturing the suture along the tissue by helically advancing a flexible helical member along the guide rail while the guide rail is within the guide device, such that the suture defines a series of turns along the tissue with a portion of each turn embedded in the tissue and another portion of each turn resting above the surface of the tissue, and a tensioning member disposed along the surface of the tissue and extending through the series of turns.

[0667] In some implementations, the tissue is tissue of the annulus of a heart valve, the annulus surrounding the valve orifice.

[0668] In some implementations, the driver is configured to suture the suture circumferentially around the valve orifice and into and along the tissue of the annulus.

[0669] In some implementations, the driver is configured to transluminally advance the helical member over and along the guide rail toward the heart.

[0670] In some implementations, the guide assembly further includes a guide frame expandable within the heart toward an expanded state.

[0671] In some implementations, the guide assembly is configured to position the guide rail within the guide device circumferentially around at least a portion of the guide frame.

[0672] In some implementations, the guide assembly further includes a plurality of fasteners that can be tightened within the heart from a proximal extracorporeal portion of the delivery assembly in a manner that draws the guide rails into the guide device around at least a portion of the guide frame.

[0673] In some implementations, the guide frame has a longitudinal axis and is expandable within the heart toward an expanded state by expanding radially away from the longitudinal axis.

[0674] In some implementations, in the guide device, the guide rails extend distally through the interior of the guide frame and out of the guide frame at the exit site to curve around the exterior and longitudinal axis of the guide frame.

[0675] In some implementations, the system further includes a tensioning tool configured to adjust the dimension of the tissue by applying tension to the tensioning member such that the tensioning member pulls each of the turns of the suture.

[0676] In some implementations, the driver is configured to sew the suture such that the suture is disposed in a spiral that is disposed in a curved path along the tissue, the curved path having a radius of curvature.

[0677] In some implementations, the tensioning tool is configured to adjust the dimension of the tissue by applying tension to the tension member such that the radius of curvature of the curved path is reduced.

[0678] In some implementations, the driver is configured to sew the suture such that the suture is arranged in a spiral that is disposed in a curved path along the tissue, the curved path having a length.

[0679] In some implementations, the tensioning tool is configured to adjust the dimension of the tissue by applying tension to the tension member such that the length of the curved path is reduced.

[0680] In some implementations, the tension member is positioned along the lumen of the guide rail, and the delivery assembly is configured to store the guide rail proximally from the series of turns, leaving the tension member exposed along the series of turns.

[0681] In some implementations, the driver is configured to stitch the suture along the tissue such that the helical member is temporarily sutured along the tissue. In some implementations, the delivery assembly is configured to (i) helically retract the helical member to unstitch the helical member from the tissue, and / or (ii) linearly retract the guide rail to leave the suture stitched along the tissue by a tensioning member extending along a series of turns.

[0682] In some implementations, the driver is configured to thread the suture along the tissue while the suture is attached to the helical member.

[0683] In some implementations, the suture is removable from the helical member once the suture has been stitched along the tissue.

[0684] In some implementations, the suture is attached to a distal end portion of the helical member, and the driver is adapted to suture the suture along the tissue by withdrawing the driver from the tissue such that the suture is drawn into and along the tissue by withdrawal of the driver.

[0685] In some implementations, the driver is adapted to suturing the suture to the tissue along the helical member.

[0686] In some implementations, the helical member is a hollow helical needle defining a channel therethrough, and the driver is configured to thread the helical member along the tissue while the suture is disposed within the channel, thereby suturing the suture along the tissue.

[0687] In some implementations, the helical member is configured to be unscrewed from the tissue, leaving the suture threaded along the tissue.

[0688] According to some implementations, the system (which may be used, for example, in a living subject or in simulated cardiac tissue) includes (i) a suture, (ii) a tension member, and / or (iii) a delivery assembly.

[0689] In some implementations, the delivery assembly includes a guide assembly including a guide rail, the guide assembly configured to transluminally advance the guide rail into the heart and position the guide rail within the guide device along the surface of the tissue.

[0690] In some implementations, the delivery assembly includes a flexible helical member.

[0691] In some implementations, the delivery assembly includes a driver coupled to a flexible helical member, and the delivery assembly is configured to (i) arrange the suture into a series of turns sutured along the tissue by the driver helically advancing the flexible helical member along the guide rail while the guide rail is within the guide device, and (ii) position the tension member along the surface of the tissue, extending through the series of turns.

[0692] According to some implementations, a system (eg, that may be used in a living subject or simulated cardiac tissue) includes an implant and / or a delivery assembly.

[0693] In some implementations, the implant comprises a suture.

[0694] In some implementations, the delivery assembly includes a guide assembly having a distal portion transluminally advanceable into the heart while in a delivery state, the guide assembly including (i) a guide frame expandable within the heart toward an expanded state, and / or (ii) guide rails, the guide assembly configured to position the guide rails within the guide device circumferentially around at least a portion of the guide frame.

[0695] In some implementations, the delivery assembly includes a flexible helical member defining a plurality of turns configured to helically advance the suture over and along the guide rail while the guide rail is within the guide device to suture the suture along the tissue, such that the suture defines a series of turns along the tissue with a portion of each turn of the suture embedded within the tissue and another portion of each turn of the suture resting above the surface of the tissue.

[0696] In some implementations, the implant further includes a tensioning member. In some implementations, the flexible helical member is configured to sew the suture along the tissue such that the suture defines a series of turns along the tissue with the tensioning member extending along the interior of the series of turns. In some implementations, the implant is configured such that tension in the tensioning member adjusts the dimension of the tissue by pulling the suture.

[0697] In some implementations, the flexible helical member is configured to suture the suture along the tissue by helically advancing the suture over and along the guide rail while the guide rail is within the guide device and the tensioning member is disposed along the lumen of the guide rail.

[0698] In some implementations, the guide assembly includes a plurality of fasteners that can be tightened within the heart via the extracorporeal portion of the delivery assembly in a manner that draws the guide rails into the guide device around at least a portion of the guide frame.

[0699] According to some implementations, the system includes a tube, a first strip, and / or a second strip.

[0700] In some implementations, the tube is transluminally advanceable into a body orifice (e.g., an orifice in a real or simulated body), and the tube defines a bend zone where cuts in the tube provide flexibility to the tube.

[0701] In some implementations, the first strip has a greater tensile strength than the bend zone, and a first end of the first strip is attached to the tube distal to the bend zone and a second end of the first strip is attached to the tube proximal to the bend zone, such that in a relaxed state of the tube, the first strip lies loose along the bend zone.

[0702] In some implementations, the second strip has a greater tensile strength than the bend zone, and a first end of the second strip is attached to the tube distal to the bend zone and a second end of the second strip is attached to the tube proximal to the bend zone, such that in a relaxed state of the tube, the second strip lies loose along the bend zone.

[0703] In some implementations, each of the first end of the first strip and the second end of the first strip is attached to the tube by welding.

[0704] In some implementations, the tube is a hypotube.

[0705] In some implementations, pulling the tube applies tension to each of the first and second strips proximally, thereby forcing each strip against the bend zone.

[0706] According to some implementations, the method includes manufacturing a guide frame usable and / or for use in a real or simulated cardiovascular system by obtaining a frame that may include a plurality of wires braided together and / or defined by a braided arrangement formed therefrom, the frame having a proximal portion and a distal portion, and each of the wires having a first end at the proximal portion of the frame and extending helically distally along the frame.

[0707] In some implementations, the method further includes invaginating the braiding device at a distal portion of the frame such that a second end of each of the wires is positioned within the frame and the distal portion of the frame is atraumatically contoured.

[0708] In some implementations, the method further includes coupling second ends of the wires together within the frame.

[0709] In some implementations, the method further includes, following manufacturing the guide frame, coupling the guide rails along an exterior of the guide frame using a plurality of fasteners extending out from the guide frame to the guide rails.

[0710] According to some implementations, the method includes manufacturing a guide frame usable and / or for use in a real or simulated cardiovascular system by obtaining a frame defined by a braiding device, the frame having a proximal portion and a distal portion.

[0711] In some implementations, the method further includes invaginating a braiding device at a proximal portion of the frame to form an invagination such that the proximal portion of the frame is contoured and positioned within an interior of the frame.

[0712] In some implementations, the method further includes heat treating the proximal portion to set the invagination, such that the guide frame is expanded via a flexible control shaft having a distal end attached to the invagination, thereby positioning the control shaft within the invagination.

[0713] In some implementations, the method further includes, following manufacturing the guide frame, coupling the guide rails along an exterior of the guide frame using a plurality of fasteners extending out from the guide frame to the guide rails.

[0714] According to some implementations, a system and / or device (which may be used in a subject's real or simulated cardiovascular system) includes a guide frame and / or a flexible control shaft.

[0715] In some implementations, the guide frame has an invaginated portion and is expandable to an expanded state in which the invaginated portion forms an invagination.

[0716] In some implementations, the flexible control shaft is coupled to the guide frame at the invagination portion and has a distal end configured to (i) advance the frame transluminally through the cardiovascular system and / or (ii) expand the frame to its expanded state within the cardiovascular system such that, in the expanded state, the distal end of the control shaft is positioned within the invagination.

[0717] According to some implementations, a device usable and / or for use in a real or simulated cardiovascular system of a subject, the device including a frame and / or a control shaft.

[0718] In some implementations, the frame may include multiple wires braided together and / or be defined by a braiding device formed therefrom, the frame having a proximal portion and a distal portion, (i) each of the wires has a first end at the proximal portion of the frame and extends helically distally along the frame, (ii) at the distal portion of the frame, the braiding device is invaginated such that a second end of each of the wires is positioned within the frame and the distal portion of the frame is atraumatically contoured, and / or (iii) the second ends of the wires are joined together within the frame.

[0719] In some implementations, the flexible control shaft is coupled to a proximal portion of the frame and configured to (a) transluminally advance the frame distally through the cardiovascular system and / or (b) expand the frame within the cardiovascular system.

[0720] According to some implementations, the system and / or device (which may be used, for example, in a living subject or simulated cardiac tissue) includes a helical member defining a plurality of turns and / or a driver configured to thread the helical member along the tissue.

[0721] In some implementations, the driver is configured to thread the helical member along the tissue so that a portion of each turn of the helical member is embedded within the tissue and another portion of each turn is positioned above the surface of the tissue.

[0722] In some implementations, the device further includes an extracorporeal portion electrically connected to the helical member via a driver and adapted to alter the tissue by applying electrical energy to the tissue via the helical member while the helical member remains threaded along the tissue, the driver being configured to unscrew the helical member from the tissue, leaving the tissue altered.

[0723] In some implementations, the helical member comprises nitinol.

[0724] In some implementations, the tissue is tissue of an annulus of a heart valve. hi some implementations, the driver is configured to thread the helical member along the annulus.

[0725] In some implementations, the helical member is heat treated so that it contracts to a predetermined shape upon application of electrical energy to the helical member.

[0726] In some implementations, the helical member is constructed from a shape memory material.

[0727] In some implementations, the extracorporeal portion includes a power source configured to provide electrical energy.

[0728] In some implementations, the extracorporeal portion (i) includes terminals configured to be electrically and mechanically connected to a power source, and / or (ii) is configured to derive electrical energy from the power source.

[0729] In some implementations, the device further includes a guide assembly including a guide rail, and the driver is configured to thread the helical member along the tissue by helically advancing the helical member over and along the guide rail while the guide rail is positioned along the tissue.

[0730] In some implementations, the guide assembly further includes a guide frame and a plurality of fasteners that can be tightened within the heart via the extracorporeal portion in a manner that draws the guide rail along tissue around at least a portion of the guide frame.

[0731] According to some implementations, the system and / or device (which may be used, for example, in a living subject or simulated cardiac tissue) includes a helical member and / or guide assembly that defines multiple turns.

[0732] In some implementations, the guide assembly has a distal portion that is transluminally advanceable into the heart while in the delivery state. In some implementations, the guide assembly includes (i) a guide frame that is expandable within the heart toward an expanded state, and / or (ii) guide rails that are disposable within the heart in a guide device around at least a portion of the guide frame, and the guide assembly is positionable within the heart such that the guide rails are positioned within the guide device and along tissue.

[0733] In some implementations, the device further comprises a driver configured to thread the helical member along the guide rail and tissue while the guide rail is within the guide device.

[0734] In some implementations, the device further comprises an extracorporeal portion electrically connected to the helical member via the driver and adapted to alter tissue by applying electrical energy to the helical member while the helical member remains threaded along the tissue.

[0735] In some implementations, the helical member comprises nitinol.

[0736] In some implementations, the helical member is heat treated so that it contracts to a predetermined shape upon application of electrical energy to the helical member.

[0737] In some implementations, the extracorporeal portion is adapted to alter tissue by applying electrical energy to the tissue via the helical member.

[0738] In some implementations, the helical member is constructed from a shape memory material.

[0739] In some implementations, the extracorporeal portion includes a power source configured to provide electrical energy.

[0740] In some implementations, the extracorporeal portion (i) includes terminals configured to be electrically and mechanically connected to a power source, and / or (ii) is configured to derive electrical energy from the power source.

[0741] In some implementations, the device includes an implant including a helical member, hi some implementations, the implant further includes a lock lockable to the implant to maintain the tissue alteration.

[0742] In some implementations, the helical member is configured to contract toward a contracted state in response to electrical energy. In some implementations, (i) the implant further includes a tensioning member, (ii) the driver is configured to thread the helical member along tissue such that the tensioning member extends along the interior of the series of turns, and / or (iii) the implant is configured such that the tensioning member can tension the helical member into a tensioned state in a manner that maintains the helical member in the contracted state while the helical member remains contracted.

[0743] In some implementations, the lock can be locked to the tension member to maintain the tension member in tension.

[0744] In some implementations, the helical member is configured to contract toward a contracted state in response to electrical energy, hi some implementations, a lock is lockable with the helical member to maintain the helical member in the contracted state.

[0745] According to some implementations, a method usable in a heart (e.g., live or simulated) includes threading a flexible helical member along tissue, such that the helical member defines a series of turns along the tissue, with a portion of each turn embedded within the tissue and another portion of each turn resting above the surface of the tissue.

[0746] In some implementations, the method further includes thereafter altering the tissue by applying electrical energy to the helical member while the helical member remains threaded along the tissue.

[0747] In some implementations, the method further includes thereafter unscrewing the helical member from the tissue, leaving the tissue altered.

[0748] In some implementations, applying electrical energy to the helical member includes applying electrical energy to the helical member from an external power source electrically connected to the helical member.

[0749] In some implementations, altering the tissue by applying electrical energy includes irreversibly altering the tissue by applying electrical energy.

[0750] According to some implementations, a method usable in a heart (e.g., live or simulated) includes transluminally advancing a guide frame into the heart while the guide frame is secured to a guide rail.

[0751] In some implementations, the method further includes expanding the guide frame within the heart.

[0752] In some implementations, the method further includes retracting the guide rail into a guide arrangement around at least a portion of the guide frame.

[0753] In some implementations, the method further includes threading a flexible helical member along the tissue while the guide rail remains within the guide device, such that the helical member defines a series of turns along the tissue, with a portion of each turn embedded within the tissue and another portion of each turn resting above the surface of the tissue.

[0754] In some implementations, the method further includes thereafter altering the tissue by applying electrical energy to the helical member while the helical member remains threaded along the tissue.

[0755] In some implementations, altering the tissue by applying electrical energy includes applying electrical energy such that the helical member contracts toward a contracted state in which the turns of the helical member are closer together, thereby altering the tissue. In some implementations, the method further includes locking the helical member in the contracted state while the electrical energy is applied to the helical member, such that the tissue remains altered.

[0756] In some implementations, locking the helical member in the contracted state includes (i) applying tension to a tensioning member positioned along the surface of the tissue and extending through each of the turns of the helical member, and / or (ii) locking tension to the tensioning member by applying a lock to the tensioning member to maintain the helical member in the contracted state.

[0757] In some implementations, locking the helical member in the contracted state includes mechanically locking the helical member in the contracted state.

[0758] According to some implementations, the system and / or device (e.g., which may be used in a living subject's or a simulated cardiovascular system) includes an extracorporeal handle, a frame having a proximal portion and a distal portion, a control shaft extending from the extracorporeal handle and coupled to the proximal portion of the frame, and / or a plurality of actuator wires.

[0759] In some implementations, the frame is transluminally advanceable within the cardiovascular system. In some implementations, a plurality of actuator wires (i) extend from the control shaft, (ii) are woven distally along at least a portion of the frame, (iii) are attached to a distal portion of the frame, and / or (iv) are actuatable from the handle to (a) radially expand the frame toward an expanded state and / or (b) pivot the frame relative to the control shaft independently of expansion of the frame.

[0760] In some implementations, the frame is a guide frame. In some implementations, the system further includes a guide rail that can be retracted into the guide device along at least a portion of the guide frame.

[0761] In some implementations, in the guide apparatus, the guide rails are placed around a central section of the guide frame, with the central section being longitudinally disposed between an upstream section of the frame and a downstream section of the frame.

[0762] In some implementations, each of the actuator wires extends from the control shaft, distally through the interior of the upstream section of the guide frame, and weaves along the downstream section of the guide frame.

[0763] In some implementations, in the expanded state of the guide frame, at least a portion of the upstream section is wider than the downstream section.

[0764] In some implementations, in the expanded state of the guide frame, at least a portion of the upstream section is wider than the central section.

[0765] In some implementations, the frame is pivotable relative to the control shaft via differential tension in the actuator wires.

[0766] In some implementations, the external handle (i) includes at least one control device to which the actuator wires are operably coupled, and / or (ii) is configured to differentially tension the actuator wires via actuation of the at least one control device.

[0767] In some implementations, the frame is configured to radially expand in response to balanced tension in the actuator wires, hi some implementations, the external handle is configured to apply balanced tension to the actuator wires.

[0768] In some implementations, at least one control device is configured with (i) a first operating mode that applies balanced tension to the actuator wires, and / or (ii) a second operating mode that applies differential tension to the actuator wires.

[0769] According to some implementations, a method usable in a cardiovascular system (e.g., live or simulated) includes using a handle attached to a frame via a control shaft, and transluminally advancing the frame into the cardiovascular system while multiple actuator wires extend from the control shaft to distal portions of the frame where each actuator wire is attached.

[0770] In some implementations, the method further includes (i) expanding the frame radially within the cardiovascular system, and / or (ii) actuating a plurality of actuator wires from the handle to pivot the frame relative to the control shaft independent of the expansion of the frame.

[0771] In some implementations, actuating the plurality of actuator wires to pivot the frame relative to the control shaft includes actuating the plurality of actuator wires via differential tension in the actuator wires to pivot the frame relative to the control shaft.

[0772] In some implementations, actuating the plurality of actuator wires to radially expand the frame includes actuating the plurality of actuator wires by applying balanced tension to the actuator wires to radially expand the frame.

[0773] In some implementations, actuating the plurality of actuator wires to radially expand the frame includes actuating the plurality of actuator wires to radially expand the frame before actuating the actuator wires to pivot the frame.

[0774] In some implementations, actuating the plurality of actuator wires to radially expand the frame includes actuating the actuator wires to pivot the frame followed by actuating the plurality of actuator wires to radially expand the frame.

[0775] In some implementations, the frame is a guide frame that is a component of a guide assembly. In some implementations, the guide assembly further includes a guide rail that can be retracted into the guide device along at least a portion of the guide frame.

[0776] In some implementations, in the guide apparatus, the guide rails are placed around a central section of the guide frame, with the central section being longitudinally disposed between an upstream section of the frame and a downstream section of the frame.

[0777] In some implementations, each of the actuator wires extends from the control shaft distally through the interior of the upstream section of the guide frame and woven along the downstream section of the guide frame, hi some implementations, actuating the actuator wires includes actuating an actuator wire woven along the downstream section of the guide frame.

[0778] In some implementations, expanding the guide frame includes expanding the guide frame such that at least a portion of the upstream section is wider than the downstream section.

[0779] In some implementations, expanding the guide frame includes expanding the guide frame such that at least a portion of the upstream section is wider than the central section.

[0780] According to some implementations, the system and / or device (e.g., which may be used in a living subject or simulated cardiac tissue) includes an implant and / or a delivery assembly. In some implementations, the delivery assembly includes a driver configured to advance the implant along the tissue. In some implementations, the delivery assembly includes a guide assembly having a distal portion transluminally advanceable into the heart while in a delivery state.

[0781] In some implementations, the guide assembly includes (i) a guide frame expandable within the heart toward an expanded state; (ii) a guide rail positionable within the heart in a guide device around at least a portion of the guide frame, wherein a driver is adapted to advance the implant along the guide rail within the guide device, thereby advancing the implant along the tissue; and / or (iii) a rider slidably mounted on the guide rail, such that as the driver advances the implant along the tissue, the tip of the implant pushes the rider along the guide rail, while the rider shields the guide frame from the tip of the implant.

[0782] In some implementations, the implant includes a helical member defining a sharp tip at its tip, hi some implementations, the rider defines lobes such that when the implant pushes the rider along the guide rail, the lobes remain disposed between the tip and the guide frame, thereby shielding the guide frame from the sharp tip.

[0783] In some implementations, the lobes are rotationally locked relative to the guide rails.

[0784] In some implementations, the lobe is rotationally locked to the guide rail via keying between the rider and the guide rail.

[0785] According to some implementations, the system and / or device (which may be used, for example, in a living subject or simulated cardiac tissue) includes a helical member defining multiple turns and / or a delivery assembly.

[0786] In some implementations, the delivery assembly includes a guide assembly having a distal portion transluminally advanceable into the heart while in a delivery state, the guide assembly including (a) a guide frame expandable within the heart toward an expanded state, (b) guide rails positionable within the heart in a guide device around at least a portion of a central section of the guide frame, and / or (c) an expandable shield positioned around at least a portion of the central section, such that (I) expanding the guide frame toward the expanded state expands the central section and the shield, and / or (II) in the guide device, the shield includes an expandable shield positioned between the guide rails and the guide frame in the central section.

[0787] In some implementations, the delivery assembly includes a driver configured to spirally advance the helical member along the guide rail within the guide device.

[0788] In some implementations, in the expanded state of the guide frame, the guide frame is at least twice as large as in the delivery state of the guide assembly. In some implementations, in the expanded state of the guide frame, the shield covers at least a majority of the periphery of the guide frame.

[0789] In some implementations, the shield comprises a resilient material.

[0790] In some implementations, the shield is defined by a woven fabric.

[0791] In some implementations, the shield is defined by a film.

[0792] In some implementations, the shield is defined by a mesh.

[0793] In some implementations, the shield has a hypotube type structure.

[0794] In some implementations, the shield is constructed from an array of interconnected struts and tessellated cells.

[0795] In some implementations, the shield is a ribbon that is wrapped around the guide frame in the delivery state of the guide assembly, and expanding the guide frame toward the expanded state causes the ribbon to slide over itself in a manner that reduces wrapping around the guide frame.

[0796] In some implementations, the shield is defined by a plurality of ribbons distributed circumferentially around the central section.

[0797] In some implementations, in the guide device, each ribbon contacts its adjacent ribbon such that the ribbons collectively cover the central section.

[0798] In some implementations, each ribbon is polymeric.

[0799] In some implementations, each ribbon is metallic.

[0800] In some implementations, in the delivery state, the ribbons are stacked like scales around the central section, and in some implementations, expanding the guide frame toward the expanded state causes the shield to expand by the ribbons sliding over each other while collectively covering the central section.

[0801] In some implementations, in the expanded state, the ribbons remain stacked in a scale-like fashion around the central section.

[0802] In some implementations, in the expanded state, the ribbons are disposed edge-to-edge around the central section.

[0803] According to some implementations, a method usable with a heart (e.g., live or simulated) includes (i) transluminally advancing a guide frame into the heart while the guide frame is secured to a guide rail via a plurality of fasteners extending out from the guide frame to the guide rail, and / or (ii) an expandable shield is positioned around a central section of the guide frame.

[0804] In some implementations, the method further includes expanding the guide frame within the heart such that the shield expands therealong.

[0805] In some implementations, the method further includes drawing the guide rail into the guide device around at least a portion of the central section by tightening at least one of the plurality of fasteners such that the shield is disposed between the guide rail and the guide frame.

[0806] According to some implementations, a system for use in cardiac tissue includes a helical member defining a plurality of turns and / or a delivery assembly.

[0807] In some implementations, the delivery assembly includes a guide assembly having a distal portion transluminally advanceable into the heart while in a delivery state, the guide assembly including (i) a guide frame expandable within the heart toward an expanded state, and / or (ii) a guide rail disposable within the heart within a guide device around at least a portion of the guide frame and defining an external thread.

[0808] In some implementations, the delivery assembly further includes a driver configured to helically advance the helical member along the external threads while the guide rail is within the guide device.

[0809] In some implementations, the external threads define a groove, and the driver is configured to helically thread the helical member along the threads while the helical member is recessed within the groove.

[0810] In some implementations, the guide rail defines a central guide rail axis and has a tissue-facing surface disposed along the guide rail closer to the central guide rail axis than the male threads, hi some implementations, in the guide device, the male threads face inward toward the guide frame and the tissue-facing surface faces radially away from the guide frame.

[0811] In some implementations, the tissue-facing surface is unthreaded and extends parallel to the external threads.

[0812] In some implementations, the tissue-facing surface is substantially flat.

[0813] In some implementations, the tissue-facing surface is concave.

[0814] According to some implementations, a method for use in cardiac tissue includes transluminally advancing a guide frame into the heart while the guide frame is secured to a guide rail defining an external thread, hi some implementations, the method further includes positioning a guide rail within a guide device around at least a portion of the guide frame such that at least a portion of the guide rail is positioned along the tissue.

[0815] In some implementations, the method further includes threading the flexible helical member into the tissue within the heart by threading and advancing the helical member along the male threads while the guide rail is within the guide device, such that the helical member defines a series of turns along the tissue, with a portion of each turn embedded in the tissue and another portion of each turn resting above the surface of the tissue.

[0816] In some implementations, the male thread defines a groove, and / or threading and advancing the helical member along the male thread includes threading and advancing the helical member along the male thread while the helical member is recessed within the groove.

[0817] In some implementations, the guide rail defines a central guide rail axis and has a tissue-facing surface disposed along the guide rail closer to the central guide rail axis than the external threads.

[0818] In some implementations, positioning the guide rail within the guide device around at least a portion of the guide frame includes positioning the guide rail within the guide device around at least a portion of the guide frame so that the male threads face inward toward the guide frame and the tissue-facing surface faces radially away from the guide frame.

[0819] In some implementations, positioning the guide rail within the guide device around at least a portion of the guide frame includes positioning the guide rail within the guide device around at least a portion of the guide frame so that the top of the male thread contacts the guide frame.

[0820] In some implementations, threading and advancing the helical member along the male threads includes threading and repeatedly rotating the helical member such that, during each rotation of the helical member, the distal tip of the helical member (i) exits the groove toward the tissue as the distal tip reaches the tissue-facing surface, (ii) penetrates the tissue at the tissue-facing surface, (iii) exits the tissue toward the male thread, and / or (iv) re-enters the groove as the distal tip returns to the male thread.

[0821] The above methods and any methods using the systems, assemblies, instruments, devices, etc. described herein can be performed on a living subject (e.g., a human or other animal) or on a simulation (e.g., a cadaver, a cadaver heart, a virtual person, a simulator, etc.). With respect to a simulation, the body part may optionally be referred to as "simulated" (e.g., a simulated heart, a simulated tissue, etc.) and may optionally include computerized and / or physical representations.

[0822] Any of the above systems, assemblies, devices, instruments, components, etc. can be sterilized (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure safety for patient use, and the methods herein can include (or additional methods can include or consist of) sterilization (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.) of one or more of the systems, devices, instruments, components, etc. described herein.

[0823] The present invention will be more fully understood from the following detailed description of implementations of the invention taken in conjunction with the drawings. [Brief explanation of the drawings]

[0824] [Figure 1] FIG. 1 is a schematic diagram of a system and its applications, according to some embodiments. [Figure 2A] FIG. 2A is a schematic diagram of a system and its applications, according to some embodiments. [Figure 2B]FIG. 2B is a schematic diagram of the system and its applications, according to some embodiments. [Figure 2C] FIG. 2C is a schematic diagram of the system and its applications, according to some embodiments. [Figure 2D] FIG. 2D is a schematic diagram of the system and its applications, according to some embodiments. [Figure 2E] FIG. 2E is a schematic diagram of the system and its applications, according to some embodiments. [Figure 2F] FIG. 2F is a schematic diagram of the system and its applications, according to some embodiments. [Figure 2G] FIG. 2G is a schematic diagram of the system and its applications, according to some embodiments. [Figure 2H] FIG. 2H is a schematic diagram of the system and its applications, according to some embodiments. [Figure 2I] FIG. 2I is a schematic diagram of the system and its applications, according to some embodiments. [Figure 3A] FIG. 3A is a schematic diagram illustrating in further detail some optional components and / or features of a guide assembly according to some implementations. [Figure 3B] FIG. 3B is a schematic diagram illustrating in further detail some optional components and / or features of the guide assembly according to some implementations. [Figure 3C] FIG. 3C is a schematic diagram illustrating in further detail some optional components and / or features of the guide assembly according to some implementations. [Figure 3D] FIG. 3D is a schematic diagram illustrating in further detail some optional components and / or features of the guide assembly according to some implementations. [Figure 3E] FIG. 3E is a schematic diagram illustrating in further detail some optional components and / or features of the guide assembly according to some implementations. [Figure 4A] FIG. 4A is a schematic illustration of a technique for positioning guide rails of a guide assembly relative to the annulus of a valve, according to some implementations. [Figure 4B]FIG. 4B is a schematic illustration of a technique for positioning the guide rails of the guide assembly relative to the annulus of the valve, according to some implementations. [Figure 5] FIG. 5 illustrates a helical member with variable thickness, according to some implementations. [Figure 6A] FIG. 6A is a schematic diagram of a guide assembly according to some implementations. [Figure 6B] FIG. 6B is a schematic diagram of a guide assembly according to some implementations. [Figure 6C] FIG. 6C is a schematic diagram of a guide assembly according to some implementations. [Figure 7] FIG. 7 illustrates that, according to some implementations, a helical member is advanced through a flexible sleeve. [Figure 8A] FIG. 8A illustrates a method of delivering a helical member toward a valve annulus according to some implementations. [Figure 8B] FIG. 8B illustrates a method of delivering a helical member toward a valve annulus according to some implementations. [Figure 9] FIG. 9 is a schematic diagram of a driver according to some implementations. [Figure 10A] FIG. 10A shows a distal portion of a shaft with reinforcing strips according to some implementations. [Figure 10B] FIG. 10B shows a distal portion of a shaft with reinforcing strips according to some implementations. [Figure 11] FIG. 11 shows a distal portion of a shaft having reinforcing strips, according to some implementations. [Figure 12A] FIG. 12A illustrates various guide frames according to some implementations. [Figure 12B] FIG. 12B illustrates various guide frames according to some implementations. [Figure 13] FIG. 13 illustrates various guide frames according to some implementations. [Figure 14] FIG. 14 illustrates various guide frames according to some implementations. [Figure 15A]FIG. 15A shows some implementations in which multiple actuator wires are used to both expand the guide frame and reorient the guide frame. [Figure 15B] FIG. 15B illustrates some implementations in which multiple actuator wires are used to both expand the guide frame and reorient the guide frame. [Figure 15C] FIG. 15C illustrates some implementations in which multiple actuator wires are used to both expand the guide frame and reorient the guide frame. [Figure 16] FIG. 16 illustrates some implementations in which multiple actuator wires are used that are woven along the downstream section of the guide frame. [Figure 17] FIG. 17 illustrates various systems and methods for spacing the guide rails from the guide frame according to some implementations. [Figure 18A] FIG. 18A illustrates various systems and methods for spacing a guide rail from a guide frame according to some implementations. [Figure 18B] FIG. 18B illustrates various systems and methods for spacing the guide rails from the guide frame according to some implementations. [Figure 19A] FIG. 19A illustrates various systems and methods for spacing a guide rail from a guide frame according to some implementations. [Figure 19B] FIG. 19B illustrates various systems and methods for spacing the guide rails from the guide frame according to some implementations. [Figure 20] FIG. 20 illustrates various implementations in which the guide assembly includes a shield disposed around the central section of the guide frame, according to some implementations. [Figure 21] FIG. 21 illustrates various implementations in which the guide assembly includes a shield disposed around the central section of the guide frame, according to some implementations. [Figure 22A] FIG. 22A illustrates various implementations in which the guide assembly includes a shield disposed around the central section of the guide frame, according to some implementations. [Figure 22B] FIG. 22B illustrates various implementations in which the guide assembly includes a shield disposed around the central section of the guide frame, according to some implementations. [Figure 23] FIG. 23 illustrates various implementations in which the guide assembly includes a shield disposed around the central section of the guide frame, according to some implementations. [Figure 24] FIG. 24 illustrates various mechanisms for reducing the likelihood of the helical member getting caught on the guide frame, according to some implementations. [Figure 25] FIG. 25 illustrates various mechanisms for reducing the likelihood of the helical member getting caught on the guide frame, according to some implementations. [Figure 26] FIG. 26 illustrates various mechanisms for reducing the likelihood of the helical member getting caught on the guide frame, according to some implementations. [Figure 27] FIG. 27 illustrates various guide frames according to some implementations. [Figure 28] FIG. 28 illustrates various guide frames according to some implementations. [Figure 29A] FIG. 29A illustrates a system and method using a flexible helical member to thread sutures of an implant along tissue, according to some implementations. [Figure 29B] FIG. 29B illustrates a system and method using a flexible helical member to thread sutures of an implant along tissue, according to some implementations. [Figure 29C] FIG. 29C illustrates a system and method using a flexible helical member to thread sutures of an implant along tissue, according to some implementations. [Figure 30A]FIG. 30A illustrates a system and method using a flexible helical member to thread sutures of an implant along tissue, according to some implementations. [Figure 30B] FIG. 30B illustrates a system and method using a flexible helical member to thread sutures of an implant along tissue, according to some implementations. [Figure 31] FIG. 31 illustrates a system and method using a flexible helical member to thread sutures of an implant along tissue, according to some implementations. [Figure 32A] FIG. 32A illustrates a system and method using a flexible helical member to thread sutures of an implant along tissue, according to some implementations. [Figure 32B] FIG. 32B illustrates a system and method using a flexible helical member to thread sutures of an implant along tissue, according to some implementations. [Figure 33A] FIG. 33A is a schematic illustration of a system and technique for positioning a guide rail along tissue and using the guide rail to guide a helical member along tissue, according to some implementations. [Figure 33B] FIG. 33B is a schematic illustration of a system and technique for positioning a guide rail along tissue and using the guide rail to guide a helical member along tissue, according to some implementations. [Figure 33C] FIG. 33C is a schematic illustration of a system and technique for positioning a guide rail along tissue and using the guide rail to guide a helical member along tissue, according to some implementations. [Figure 33D] FIG. 33D is a schematic illustration of a system and technique for positioning guide rails along tissue and using the guide rails to guide a helical member along tissue, according to some implementations. [Figure 33E]FIG. 33E is a schematic illustration of a system and technique for positioning a guide rail along tissue and using the guide rail to guide a helical member along tissue, according to some implementations. [Figure 34A] FIG. 34A is a schematic illustration of a system and technique for positioning a guide rail along tissue and using the guide rail to guide a helical member along tissue, according to some implementations. [Figure 34B] FIG. 34B is a schematic illustration of a system and technique for positioning a guide rail along tissue and using the guide rail to guide a helical member along tissue, according to some implementations. [Figure 35A] FIG. 35A is a schematic illustration of a system and technique for positioning a guide rail along tissue and using the guide rail to guide a helical member along tissue, according to some implementations. [Figure 35B] FIG. 35B is a schematic illustration of a system and technique for positioning a guide rail along tissue and using the guide rail to guide a helical member along tissue, according to some implementations. [Figure 36A] FIG. 36A is a schematic illustration of a system and technique for positioning a guide rail along tissue and using the guide rail to guide a helical member along tissue, according to some implementations. [Figure 36B] FIG. 36B is a schematic illustration of a system and technique for positioning a guide rail along tissue and using the guide rail to guide a helical member along tissue, according to some implementations. [Figure 37] FIG. 37 is a schematic illustration of a system and technique for positioning guide rails along tissue and using the guide rails to guide a helical member along tissue, according to some implementations. [Figure 38]FIG. 38 is a schematic illustration of a system and technique for positioning guide rails along tissue and using the guide rails to guide a helical member along tissue, according to some implementations. [Figure 39] FIG. 39 is a schematic diagram of a guide assembly including guide rails having one or more electrodes thereon, according to some implementations. [Figure 40] FIG. 40 is a schematic diagram illustrating a replacement heart valve having multiple electrodes disposed thereon adapted to guide the positioning of the valve within the heart, according to some implementations. [Figure 41A] FIG. 41A illustrates a system and method for using electrical energy to contract tissue at the annulus using a helical member that is threaded along the tissue, according to some implementations. [Figure 41B] FIG. 41B illustrates a system and method for using electrical energy to contract tissue at the annulus using a helical member that is threaded along the tissue, according to some implementations. [Figure 41C] FIG. 41C illustrates a system and method for using electrical energy to contract tissue at the annulus using a helical member that is threaded along the tissue, according to some implementations. [Figure 42A] FIG. 42A illustrates a system and method for using electrical energy to contract tissue at the annulus using a helical member that is threaded along the tissue, according to some implementations. [Figure 42B] FIG. 42B illustrates a system and method for using electrical energy to contract tissue at the annulus using a helical member that is threaded along the tissue, according to some implementations. [Figure 42C] FIG. 42C illustrates a system and method for using electrical energy to contract tissue at the annulus using a helical member that is threaded along the tissue, according to some implementations. DETAILED DESCRIPTION OF THE INVENTION

[0825] The disclosed systems, apparatus, devices, methods, etc. should not be construed as limiting in any way. Instead, the present disclosure is directed to all novel and non-obvious features and aspects of the various disclosed implementations and applications, both alone and in various combinations and subcombinations with one another. The disclosed systems, apparatus, devices, methods, etc. are not limited to any particular aspect, feature, or combination thereof, nor do the disclosed systems, apparatus, devices, methods, etc. require that any one or more particular advantages exist or problems be solved.

[0826] 1 and 2A-I, referenced herein, are schematic illustrations of a system 100 and its application, according to some implementations. The system 100 comprises an implant 160 and a delivery assembly 110 comprising a guide assembly 120 adapted to guide implantation of the implant. The system 100 may be used on atrioventricular valves of the heart (e.g., of a living subject or a subject, such as a simulated subject), such as the mitral valve or tricuspid valve.

[0827] In some implementations, the implant 160 is adapted to reduce a dimension (e.g., a circumference) of tissue in the heart (e.g., in the annulus 10 of a valve). For example, the implant 160 may be an annuloplasty implant configured to reduce regurgitation in an atrioventricular valve of the heart.

[0828] Figure 1 shows the components of system 100 disassembled. Figures 2A-I show at least some steps in the application of system 1 to treat a heart valve. Although the valve shown is the mitral valve, the system and techniques may be similarly used with other valves of the heart, such as the tricuspid valve.

[0829] Implant 160 may include a helical member 165 (e.g., a coil), such as a helical tissue anchor, that extends around and along central channel 166, thereby defining a helix that defines central channel 166. Helical member 165 is adapted to be anchored along tissue (e.g., valve annulus 10) and then contracted (e.g., compressed) axially to contract (e.g., compress) the tissue. For example, this contraction may be used to draw tissue radially inward to circumferentially reduce the size of the valve annulus.

[0830] The helical member 165 is adapted to be anchored in tissue (i.e., screwed into tissue) via rotation. The threaded axis of the helical member 165 can be positioned substantially parallel to the surface of the tissue, for example, within the tissue (e.g., the helical member is deep within the tissue), outside the tissue (e.g., the helical member is shallower within the tissue), or coincident with the surface of the tissue. Regardless of the depth within the tissue, after implantation, each turn of the helix can be positioned partially within and partially outside the tissue.

[0831] In some implementations, the helical member 165 has a sharpened tip 167 adapted to facilitate advancement of the helical member through tissue. The helical member 165 may be sufficiently flexible to be advanced transluminally into the heart and curved around the annulus 10 of the valve. However, the helical member may also be sufficiently stiff to be screwed into tissue, such as by applying a torque to the proximal end of the helical member. For example, the helical member 165 may generally exhibit deflection flexibility (e.g., its central longitudinal axis may be easily deflected), but may generally exhibit torsional stiffness (e.g., the helix may resist twisting when screwed into tissue).

[0832] In some implementations, the helical member 165 is configured to have a constant pitch along its length and / or such that the pitch remains substantially constant during anchoring to tissue. Nevertheless, in some implementations, and as described below, the helical member 165 can be axially contracted (e.g., its pitch reduced) after being anchored to tissue in order to contract the tissue.

[0833] In some implementations, the guide assembly 120 includes a guide rail 122 adapted to position and guide the implantation of the implant 160 (e.g., its helical member 165) along the annulus 10, e.g., by at least partially assuming the shape that the implant 160 assumes upon implantation. For example, the guide rail 122 may extend along the tissue to provide a trajectory along which the implant travels.

[0834] In some implementations, once the guide assembly 120 is in place, the helical member 165 is advanced (e.g., incrementally threaded onto) the guide rails 122 out of the tube 118 of the delivery assembly 110, so that the guide rails direct implantation of the implant along the tissue. The guide rails 122 can thereby at least partially define the shape that the implant 160 will take upon implantation.

[0835] As shown, the guide rail 122 may arc around at least a portion of the annulus 10, thereby anchoring the helical member 165 in an arc around at least a portion of the annulus.

[0836] In some implementations, the guide rail 122 has a thickness that limits the depth to which the helical member 165 can penetrate into tissue, e.g., by the guide rail abutting the surface of the tissue. Figures 2B-D schematically illustrate an example in which the implant is partially embedded in 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. For example, the guide rail 184 can have a thickness 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 (i.e., the inner diameter of the helical member).

[0837] To facilitate penetration of the helical member 165 into tissue and / or withdrawal of the guide rail 122 from the helical member, the thickness of the guide rail may be configured to 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.

[0838] In some implementations, the guide rail 122 is resistant to inward compression, thereby maintaining its thickness during implantation. In some implementations, the guide rail 122 is a hypotube that is flexible enough to arc around the annulus 10 (e.g., by defining a slit therealong).

[0839] At a distal portion of guide assembly 120, the guide assembly may also include a guide frame 124 adapted to facilitate positioning of guide rails 122 along the valve annulus 10. The distal portion of guide assembly 120 may be transluminally advanceable into the subject's heart, and guide frame 124 may be expandable within the heart.

[0840] In some implementations, the guide frame 124 can be coupled to a control shaft 126 (eg, a distal end of the control shaft) configured to facilitate positioning and / or expansion of the guide frame.

[0841] In some implementations, during implantation of the implant 160, the guide frame 124 may be positioned at the distal end of the catheter 128, for example, with the control shaft 126 extending through the lumen of the catheter. In some implementations, the guide frame 124 and / or the control shaft 126 are also positioned in this manner during advancement into the heart.

[0842] In some implementations, the guide assembly 120 does not include a control shaft 126; for example, the guide frame 124 may be coupled (eg, fixedly attached) to the catheter 128.

[0843] In some implementations, the guide assembly 120 can be advanced transluminally (e.g., transfemorally) through the sheath 112 of the delivery assembly 110 while the guide frame 124 is in a contracted state, and once deployed out the distal end of the sheath, the guide frame 124 is expanded within the heart.

[0844] In some implementations, this expansion can be achieved by simply releasing the constraint on the guide frame (e.g., allowing the guide frame to self-expand), or by applying an expansion force to the guide frame, such as with a mechanical actuator or balloon, to expand the guide frame.

[0845] In some implementations, the guide frame 124 may be elastic (e.g., may be elastically expandable), such as being inherently biased to expand or inherently biased to contract, or may simply be flexible (e.g., may be plastically expandable).

[0846] In some implementations, the guide frame 124 includes (e.g., is formed from) a braided filament (e.g., wire). In some implementations, the guide frame 124 is formed by cutting stock material (e.g., cut from a tube).

[0847] In some implementations, the guide frame 124 may be formed from a metal (e.g., nitinol, stainless steel, and / or cobalt chrome). In some implementations, the guide frame 124 may be formed from a polymer.

[0848] In some implementations, while expanded, in a native valve, the guide frame 124 may push the valve leaflets away from each other, with the guide frame pressing against the tissue of the annulus. Nevertheless, the valve may continue to function at least partially, e.g., because the guide frame 124 opens to allow blood to flow therethrough, and / or because the leaflets AL and PL remain partially functional (e.g., downstream of the guide frame) to provide an ultimate unidirectional flow of blood through the valve, which may be sufficient for the duration of the procedure.

[0849] In some implementations, the guide assembly 120 includes one or more valve members, such as artificial valve leaflets, inside the guide frame 124 to provide temporary valve function during the procedure.

[0850] In some implementations, the guide frame 124 may have an upstream section 121 adapted to be positioned in the atrium 12 upstream of the valve and a downstream section 127 adapted to be positioned in the ventricle 14 downstream of the valve. The guide frame 124 may be shaped to facilitate placement of the central section 125 of the guide frame between the upstream and downstream sections at the atrioventricular valve annulus 10 between the atrium and the ventricle, e.g., at / against the upstream surface of the annulus. For example, as shown, while the guide frame 124 is in its expanded state, the downstream section 127 may taper away from the central section 125 so that the downstream section can be advanced downstream from the atrium and through the atrioventricular valve until the central section rests against the upstream surface of the valve annulus. In some implementations, the central section 125 may be positioned approximately perpendicular to a central longitudinal axis ax1 of the guide frame 124 extending from the upstream section to the downstream section.

[0851] In some implementations, the frame 124 may define a concave waist in the central section 125 .

[0852] In some implementations, to facilitate positioning of the guide rail 122 along the annulus (e.g., to guide the helical member 165 therealong), the guide assembly 120 may include a plurality of fasteners distributed along a portion of the circumference of the central section of the guide frame 124 (e.g., collectively describing an arc around the circumference). In the example shown, each of these fasteners is in the form of (or includes) a respective loop 140.

[0853] In some implementations, each loop 140 is looped around a component (e.g., a strut) of the guide frame and guide rail. In some implementations, the guide rail 122 extends through the loop 140 (e.g., by threading through the loop) such that the guide rail extends circumferentially (e.g., in an arc) around at least a portion of the guide frame. Thus, when the guide frame 124 is expanded and placed within the native valve (with the guide rail 122 positioned along the central section 125), this arrangement positions the guide rail along the tissue of the valve annulus (e.g., in contact with the atrial surface of the valve annulus).

[0854] In some implementations, the guide rails 122 can extend along the tissue (e.g., of the annulus 10) in a manner that complements (e.g., generally matches) the shape of the tissue. In some implementations, this can be facilitated by the guide frame 124 being sufficiently flexible so that its expanded shape is dictated by the existing shape of the tissue.

[0855] In some implementations, the implant 160 may include a tension member 186 (e.g., an elongated contractile member such as a wire, cable, suture, or ribbon) that extends through the central channel 166 of the helical member 165 after implantation.

[0856] In some implementations, during delivery, the tension member 186 can be positioned through the guide rail 122 (such as through a lumen defined by the guide rail, as shown) or along the guide rail.

[0857] In some implementations, after the guide rails and guide frame are withdrawn, the tension member 186 remains behind as a component of the implant 160. In some implementations, the tension member can be introduced after the helical member 165 is delivered and / or anchored. In some implementations, no separate tension member is used, for example, the helical member 165 itself adjusts the tissue.

[0858] 2A-I depict a series of steps that may be performed by an operator to circumferentially reduce the size of a heart valve annulus 10, according to some implementations. While Figures 2A-I illustrate the sequence of at least some steps in a procedure, which may in fact be performed in the order shown, these figures are also intended to illustrate the capabilities of system 100 independent of any particular sequence of steps.

[0859] 2A shows the guide assembly 120 deployed within the heart so that the guide rails 122 extend along the tissue of the valve annulus 10 (e.g., in contact with the atrial surface of the annulus). As shown, loops 140 can hold the guide rails 122 along the outer surface (e.g., periphery) of the guide frame 124 to position the guide rails along the annulus.

[0860] The helical member 165 is then screwed into the tissue so as to be anchored along the tissue (FIGS. 2B-D), guided by the guide rails 122.

[0861] In some embodiments, the guide rails extend from around the guide frame 124 into the tube 118 and through the tube proximally, away from the heart (e.g., outside the subject). In some embodiments, as shown, the tube 118 extends along the guide frame 124 such that the guide rails 122 exit the tube at a gentle incline (e.g., an angle of 0 to 70 degrees) relative to the annulus to facilitate threading of the helical member 145 into the tissue of the annulus. In some embodiments, the tube 118 extends distally out of the sheath 112, for example, as shown. In some embodiments, the guide assembly 120 does not include the tube 118; for example, the guide rails 122 simply exit a distal opening of the catheter 128 and extend around the guide frame 124.

[0862] In some implementations, the catheter 128 defines a lumen 128a through which the tube 118 and / or the guide rail 122 extend. The catheter 128 can define another lumen 128b through which the control shaft 126 extends. The lumen 128a can extend along the control shaft 126 and / or along the lumen 128b.

[0863] In some implementations, the driver 116 of the delivery assembly 110 can be reversibly engaged with a proximal portion of the helical member 165 (e.g., its head 169) to screw the helical member into tissue by rotating the helical member.

[0864] In some implementations, the driver 116 extends from the heart, where it is engaged with the head 169, through the delivery assembly 110, to a proximal end of the driver that is coupled to an anchor handle 117 that includes an anchor release mechanism 117a.

[0865] In some implementations, the anchor handle 117 may be used to anchor the helical member to tissue, for example, by rotating the anchor handle to thread the helical member along the tissue.

[0866] In some implementations, the operator can release the helical member 165 from the driver 116 by operating the anchor release mechanism 117a, so that the driver can be withdrawn from the heart, leaving the helical member embedded along the tissue.

[0867] In some implementations, as described above, once the helical member 165 is anchored, a portion of each turn of the helical member is embedded within the tissue of the annulus 10, and another portion of each turn is located outside the tissue (e.g., within the atrium 12).

[0868] In some implementations in which the guide assembly 120 includes a tube 118, the driver 116 may be advanced through the tube, driving the helical member 165 out of the tube and into tissue.

[0869] In some implementations, following anchoring helical member 165 along tissue ( FIG. 2D ) and / or disengaging driver 116 from anchor head 169, at least a portion of guide assembly 120 is withdrawn from the heart, e.g., via sheath 112. For example, as shown in FIGS. 2E and 2F , guide rail 122 can be withdrawn from inside helical member 165 (e.g., from central channel 166 of the helical member), leaving tension member 186 extending through the central channel of the helical member and / or extending through loop 140. FIG. 2E shows guide rail 122 partially withdrawn, and FIG. 2F shows guide rail fully withdrawn.

[0870] In some implementations, withdrawal of the guide rail 122 from the helical member 165 can be achieved by pulling (e.g., from outside the object) so that the guide member slides out of the central channel 166.

[0871] In some implementations, the guide frame 124 is also retracted before using the tensioning member 186 to retract the tissue. To accomplish this, the loop 140 may be opened (e.g., as described in more detail below) to unloop the loop so that it no longer couples the tensioning member 186 and / or the helical member 165 to the guide frame 124.

[0872] In some implementations, the loop 140 is loosened (or even fully opened) before withdrawing the guide rail 122 .

[0873] FIG. 2G shows the guide frame 124 extracted (e.g., following extraction of the guide rail 122), with the tension member 186 extending from the distal end of the anchored helical member 165, proximally through the central channel 166 of the helical member, and into the tube 118.

[0874] 2H, implant 160 is then axially contracted by applying tension to tension member 186 (e.g., by pulling the tension member proximally from outside the subject). In some implementations, due at least in part to a first stop 164a secured to the distal end of guide rail 122, which prevents the distal end of the guide rail from sliding proximally through helical member 165, tensioning tension member 186 causes the helical member to contract longitudinally.

[0875] In some implementations, the first stop 164a is a toggle "T-shaped" stop. The tensioning tool 180 of the delivery assembly 110 can be advanced (e.g., through the sheath 112) and used to facilitate the application of tension, for example, by applying a reference force while tensioning the tension member (FIG. 2H).

[0876] In some implementations, the tensioning tool 180 can lock the tension to the tensioning member 186, such as by locking the second stopper 164b (e.g., a lock) onto the tensioning member (e.g., against the anchor head 169).

[0877] In some implementations, second stop 164b can be a crimp that tension tool 180 crimps onto tension member 186. In some implementations, second stop 164b (and / or tension tool 180) can be any of those described in the following publications, which are incorporated herein by reference: U.S. Patent Application Publication No. 2019 / 0274674 by Sutherland et al. U.S. Patent Application Publication No. 2020 / 0015971 by Brauon et al. U.S. Patent Application Publication No. 2021 / 0145584 by Kasher et al.

[0878] In some implementations, excess tensioning member 186 can then be trimmed, for example, by tensioning tool 180 or a dedicated cutting tool that cuts the tensioning member just proximal to second stop 164b. At this point, tensioning tool 180 (and optionally the entire remainder of delivery assembly 110) can be removed from the subject (FIG. 2I).

[0879] Reference is further made to FIGS. 3A-E, which are schematic diagrams illustrating in further detail some optional components and / or features of guide assembly 120 according to some implementations.

[0880] In some implementations, the fastener (e.g., loop 140) is formed by one or more longitudinal members (e.g., thread, suture, ribbon, rope, wire, cable, or string), e.g., each longitudinal member defining a respective loop.

[0881] In some implementations, the longitudinal member extends from an extracorporeal proximal portion of the delivery assembly 110 through the guide assembly 120 and forms a loop 140 at the guide frame 124, e.g., on its outer surface. The longitudinal member may extend through the catheter 128 and / or the control shaft 126, e.g., to guide the guide frame 124 therein.

[0882] In some implementations, from the interior of the guide frame 124, the longitudinal member may extend out from the guide frame (e.g., between its posts), loop around the guide rail 122 to define a loop 140, and extend back into the interior of the guide frame. In some implementations, the longitudinal member then passes back out again through the guide assembly and out of the object.

[0883] In some implementations, releasing the loops 140 from the implant 160 (FIGS. 2F-G) is accomplished by simply releasing one end of each longitudinal member and pulling the other end of the longitudinal member (e.g., from outside the subject) until the longitudinal member unloops from the guide rail 122.

[0884] In some implementations, the guide assembly 120 may include multiple tubular rods 148, e.g., one rod per longitudinal member, through which the longitudinal members extend. The rods 148 may extend through the catheter 128 and / or the control shaft 126 to guide the guide frame 124, e.g., therethrough.

[0885] In some implementations, at least in some states of the guide assembly 120 (e.g., during anchoring of the helical member 165), the distal opening of each rod is positioned (e.g., facing) against the inner surface of the guide frame 124, e.g., against its posts.

[0886] In some implementations, such as the example shown, the rod 148 extends from the control shaft 126 out to the interior of the guide frame 124 and to the inner surface of the guide frame.

[0887] In some implementations, tension on the longitudinal members holds the guide rails 122 against the guide frame 124 , for example, by sandwiching the guide frame between the guide rails and the rods 148 .

[0888] In some implementations, the rods 148 are substantially longitudinally incompressible, thereby providing a reference force that cooperates with the tension on the longitudinal members. Notwithstanding this, the rods 148 can be flexible (e.g., laterally), e.g., sufficiently flexible to allow expansion and contraction of the guide frame 124.

[0889] In some implementations, the guide assembly 120 includes a plurality of spacers 130 that maintain spacing (e.g., radial spacing) between the guide rail 122 and the guide frame 124, even while the loop 140 pulls the guide rail toward the guide frame. This spacing may advantageously facilitate anchoring of the helical member 165 by allowing the sharp tip 167 to pass between the guide rail and the guide frame as the helical member rotates. For example, this spacing may reduce the likelihood that the helical member 165 will catch or thread on the guide frame 124 and / or fixate the guide frame to tissue.

[0890] In some implementations, the spacers 130 are spacer wires that extend longitudinally along the outer surface of at least the central section 125 of the guide frame (e.g., perpendicular to the central section). In some implementations, each individual wire is looped to form, for example, two spacers 130 on opposite sides of the guide frame 124. For example, as shown, each individual wire can be looped around the downstream section 127 of the guide frame 124.

[0891] In some implementations, in the upstream section 121 and / or the downstream section 127, the wires defining the spacers 130 are disposed inside the guide frame 124. In some implementations, each spacer 130 is woven in and out of the guide frame 124, with the spacer disposed on the outside of the guide frame in the central section 125. Such an arrangement may advantageously provide additional mechanical support to the guide frame and / or maintain each spacer in its designated circumferential position around the guide frame.

[0892] In some implementations, one or more of the spacers 130 function as mechanical actuators to expand (and optionally compress) the guide frame 124 once the guide assembly 120 is positioned within the heart. For example, the spacer 130 can be pulled in a manner that axially compresses the guide frame by pulling the distal end of the guide frame proximally toward the proximal end of the guide frame, and the guide frame expands radially in response to this axial compression. Alternatively or additionally, the spacer 130 can be pushed in a manner that bows the spacer radially outward and pulls the guide frame radially outward.

[0893] For clarity and simplicity, spacers 130 have been omitted from FIGS. 1-2I.

[0894] In some implementations, the rod 148 also functions as a spacer (e.g., spacer 130 is not used) by the rod protruding slightly through the guide frame 124 and guide rail 122, thereby holding the guide rail away from the guide frame.

[0895] In some implementations, the guide rail 122 includes multiple imaging markers 123 (e.g., fluorescent and / or echogenic markers) spaced along the guide rail at predetermined intervals. The imaging markers 123 are shown in FIG. 1 but are omitted from other figures for clarity and simplicity. In some implementations, the imaging markers 123 can be used, for example, to visualize the procedure and / or to verify a particular step of the procedure before proceeding to a subsequent step. For example, the imaging markers 123 can be used to verify the position of the guide rail 122 around the guide frame 124 (e.g., around its central section 125), which is positioned in a manner that facilitates placement of the guide rail along (e.g., parallel to) the valve annulus.

[0896] 3A-D show an exemplary technique for delivering and deploying the guide assembly 120 within the heart prior to implanting the implant 160 (e.g., prior to the steps shown in FIGS. 2A-I) according to some implementations. FIG. 3E shows the implant 160 being embedded around the guide assembly once fully deployed within the heart.

[0897] In some implementations, during delivery of guide assembly 120 to the heart (e.g., transluminal delivery), the guide assembly is constrained in a delivery state, e.g., within sheath 112. In the delivery state, guide frame 124 is compressed radially inward (e.g., in a substantially narrow and / or elongated configuration).

[0898] In some implementations, in the delivery state, the guide rails 122 are disposed along (e.g., substantially parallel to) the compressed guide frame 124. In some implementations, in the delivery state, the guide rails 122 are at least partially curved (e.g., spiral) around the compressed guide frame.

[0899] Regardless of the position of guide rail 122 relative to compressed guide frame 124 in the delivery state, loop 140 may already extend out from guide frame 124 and loop around guide rail 122. In the delivery state, exit site 142 where loop 140 extends out from the guide frame may be located along central section 125, e.g., extending away from the exit site and looping around the guide rail.

[0900] According to some implementations, Figure 3A depicts the state of guide assembly 120 immediately after deployment out of sheath 112, e.g., with guide frame 124 slightly expanded. Thus, in some implementations, Figure 3A substantially depicts the delivery state of guide assembly 120, with guide rails 122 at least partially curved (e.g., spiraling) around the compressed guide frame.

[0901] According to some implementations, FIG. 3A may represent the state of guide assembly 120 after guide rails 122 have been moved (e.g., pulled) into a spiral configuration after the guide assembly has been deployed out of sheath 112, for example, from a delivery state in which the guide rails are positioned substantially parallel to the compressed guide frame.

[0902] Once the guide assembly 120 is positioned within the heart (eg, once deployed out of the sheath), the guide frame 124 can be radially expanded within the heart (FIG. 3B).

[0903] In some implementations, the fastener (e.g., loop 140) can be tightened in a manner that pulls guide rail 122 toward alignment along central section 125, e.g., so that the guide rail extends circumferentially around at least a portion of the central section. This is illustrated by the transition from FIG. 3B through FIG. 3C to FIG. 3D. Tightening of the loop (e.g., tensioning of the longitudinal members that define the loop) holds the guide rail to guide frame 124 at central section 125. As described above, for implementations in which guide assembly 120 includes spacer 130, the spacer maintains spacing between guide rail 122 and guide frame 124, e.g., is sandwiched between the guide rail and guide frame upon tightening of loop 140.

[0904] In some implementations, tightening of the fasteners is achieved for each fastener (e.g., for each loop 140) by sequentially pulling one or both ends of the longitudinal member of that loop from outside the object.

[0905] In some implementations, before guide assembly 120 reaches its deployed state (e.g., the state shown in FIG. 3D ), different points along guide rail 122 may be located at different distances from central section 125. In the illustrated example (e.g., in FIGS. 3A-C ), the distal end of guide rail 122 is located approximately at central section 125, while points along the guide rail that are progressively farther from the distal end of the guide rail are located progressively further (e.g., progressively proximal and / or upstream) from the central section.

[0906] In some implementations, the loops 140 may have different exposed lengths (e.g., exposed lengths outside the guide frame 124) to accommodate, for example, the resulting different distances between the guide rails and the loop's exit site 142 from the guide frame. Thus, during tightening of the loops 140, the longitudinal member of each loop may be pulled by different amounts to accommodate the different exposed lengths to align the guide rails with the central section 125.

[0907] In some implementations, both the expansion of the guide frame 124 and the positioning of the guide rails 122 along the central section 125 are performed within the atrium 12 before moving the guide assembly into (or deeper than) the native valve to position the guide rails along the annulus 10. In some implementations, the guide rails 122 may act as a flange for the guide assembly 120, e.g., such that downstream movement of the guide assembly causes the guide rails to abut against the annulus, e.g., preventing further downstream movement of the guide assembly.

[0908] In some implementations, expansion of guide frame 124 and / or positioning along central section 125 of guide rail 122 is performed subsequent to positioning the guide frame on the native valve, e.g., such that the guide frame does not require further repositioning before anchoring of helical member 165. In some implementations, positioning along the central section of guide rail 122 also positions the guide rail along the valve annulus, e.g., central section 125 may be positioned along the valve annulus prior to positioning the guide rail.

[0909] In some implementations, it may be desirable for the helical member 165 to be anchored along a shorter stretch of the annulus, for example, rather than along a stretch whose length is predetermined by the configuration of the system 100. For example, while the figures show the system 100 capable of anchoring the helical member 165 in an arc extending approximately halfway around the annulus, the operator may determine that for a particular subject, it is desirable to anchor the helical member along less than halfway around the annulus.

[0910] In some implementations, the operator can position a smaller portion of the guide rail 122 along the central section 125 by tightening only a subset of the fasteners, and then install only the positioned portion of the guide rail along the desired extension or annulus. In some implementations, this mechanism can be facilitated by imaging markers 123. For example, visualization of the imaging markers 123 can facilitate determining how well the guide rail 122 is positioned along the central section 125 and / or along the annulus.

[0911] Reference is now made to Figures 4A and 4B, which are schematic illustrations of a technique for positioning guide rails 122 relative to the valve annulus 10 such that the guide rails conform to the contours of the valve, according to some implementations.

[0912] The annulus may not have a uniform height, for example, it may be saddle-shaped. Thus, for example, techniques are disclosed for uniformly retracting the guide rail 122 relative to the atrial-facing surface of the annulus 10 so that the guide rail rests conformally against the atrial-facing surface of the annulus.

[0913] In some implementations, before positioning the guide rails against the annulus, the guide rails 122 are positioned around the guide frame 124 in the atrium 6, and the exit site 142 is positioned at the downstream section 127 of the guide frame, e.g., in the ventricle 8, such that the annulus 10 is positioned between the exit site and the guide rail ( FIG. 4A ). For example, in some implementations, before positioning the guide rails against the annulus, the guide frame 124 is positioned within the heart such that each fastener 140 exits the guide frame at a respective exit site 142 in the ventricle. As shown in FIG. 4A , the fasteners 140 can extend upstream through the valve orifice into the atrium where they loop around the guide rail 122. In some implementations, the fasteners 140 can loop again downstream to the same exit site, e.g., as shown.

[0914] 4A and 4B, the fastener 140 can be tightened to position the guide rail against the atrial-facing surface of the annulus. Tightening the fastener 140 can retract each segment of the guide rail downstream toward the ventricle (e.g., by the fastener pulling the guide rail toward its exit site) until the guide rail 122 abuts (e.g., is stopped by) the respective segment of the annulus.

[0915] Thus, in some implementations, the guide rails generally conform to the contours of the valve annulus, thereby advantageously desensitizing the system to the location (e.g., depth) of the guide frame within the valve and / or fastener exit site, which may therefore eliminate any need to ensure that the central section 125 of the guide frame (e.g., the section around which the exit site is positioned) is uniformly positioned along the native valve.

[0916] 5, reference is now made to an implementation of helical member 165a (e.g., a variation of helical member 165 that may optionally be used with and / or for use in guide assembly 120 and / or delivery assembly 110). As shown, helical member 165a has a greater thickness toward its proximal end (e.g., head 169 in FIGS. 2F-I) than toward its distal tip 167a. For example, as shown, the thickness of helical member 165a may be tapered, gradually increasing from distal tip 167a toward the proximal end.

[0917] In some implementations, the helical member may have a graduated thickness, for example, the thickness of the helical member may increase in discrete increments from the distal tip to the proximal end.

[0918] In some implementations, this varying thickness advantageously provides greater steerability and / or flexibility in thinner distal regions of the helical member (e.g., regions that follow an arcuate path along the annulus), while thicker proximal regions are better suited to torque transmission. For example, the torque required to rotate the entire helical member is applied to the proximal end (e.g., head 169), and the proximal regions of the helical member are sufficiently stiff to transmit this torque. Progressively distal regions of the helical member are required to transmit progressively less torque to the progressively smaller regions remaining distal to them, and therefore can be made thinner, translating torque transmission into flexibility.

[0919] Additionally and / or alternatively, in some implementations, the helical member 165a may be made of a different material and / or structure that makes it more flexible and / or maneuverable, for example, toward the distal end than toward the proximal end, thereby providing a more flexible and / or maneuverable section toward the distal end while providing the above-mentioned advantage of additional torque strength toward the proximal end of the helical member.

[0920] 6A-C, which are referenced herein, are schematic diagrams of guide assembly 120a according to some implementations. In some implementations, guide assembly 120a may be a variation of or substantially identical to guide assembly 120 (e.g., guide assembly 120a may include guide frame 124, guide rails 122, and fasteners 140). In some implementations, guide assembly 120a may be a component of delivery assembly 110a.

[0921] In some implementations, guide assembly 120a includes a guide rail (e.g., guide rail 122) and a guide frame (e.g., guide frame 124). In some implementations, the guide assembly includes a control shaft 126a coupled to guide frame 124 at a distal end of the control shaft. Control shaft 126a may be a variation of control shaft 126. Delivery assembly 110a may be a variation of or substantially identical to delivery assembly 110, unless otherwise noted.

[0922] In some implementations, the delivery assembly 110a includes a handle 150 on its extracorporeal portion. The handle 150 can be used to control the delivery of the guide assembly 120a into the heart and / or to guide the implantation of the helical member 165 along the valve annulus.

[0923] In some implementations, it may be advantageous to maintain the guide rail 122 (e.g., its distal end 132) in a fastened state to the guide frame 124 before positioning the guide rail 122 in its guide device about the guide frame 124. For example, such a fastened (e.g., fixed) state may advantageously prevent the fastener 140 from slipping off the distal end of the guide rail (e.g., by preventing the guide rail from sliding off the fastener). Alternatively, or additionally, such a fastened (e.g., fixed) state may advantageously maintain the guide rail in a particular delivery state. In some implementations, the guide rail may be fastened in a state preferred for transcatheter delivery, such as by minimizing the diameter of the guide assembly in that delivery state.

[0924] In some implementations, to provide such fastening of the guide rail to the guide frame, the guide assembly 120a includes a fixed wire 144 that fastens the distal end 132 of the guide rail 122 to the guide frame 124. For example, the fixed wire can be attached to the connector 133 of the guide rail in a manner that fastens the connector 133 to a connection location 146 on the guide frame.

[0925] In some implementations, the connector 133 is an eyelet, and the fixation wire 144 extends out from the guide frame and is threaded (e.g., looped) through the eyelet to fasten the connector 133 to a connection location 146 on the guide frame. In this way, the distal end 132 of the guide rail 122 is maintained fixed relative to the guide frame at the connection location 146 during delivery and / or positioning (e.g., expansion) of the guide frame at the valve orifice ( FIG. 6A ).

[0926] In some implementations, as shown, the eyelets of the connector 133 are transverse to (eg, lie across the cross section of) the guide rail itself.

[0927] In some implementations, once the guide frame is delivered to the heart and / or once the guide frame is expanded and / or positioned within the valve orifice to be treated, the distal end 132 may be released (e.g., moved away) from the connection location 146. In some implementations, the distal end 132 may be released by loosening and / or withdrawing the fixation wire 144 from the connector 133 ( FIG. 6B ).

[0928] In some implementations, the distal end 132 can be released by actuating a control 152 on the handle 150. Releasing the distal end 132 from the connection location 146 can allow the guide rail 122 to be positioned within the guide apparatus about the guide frame 124 (e.g., via tightening of the fasteners 140). That is, in some implementations, tightening the distal-most fastener 140a of the fasteners can cause the distal end to pivot upstream toward the central section. For example, releasing the distal end 132 from the connection location 146 can allow the distal end to move, e.g., pivot, into a position suitable for the guide apparatus in response to tightening of the loop 140, e.g., moving upstream of the central section of the guide frame.

[0929] 6C shows the helical member 165 advanced along the guide rail 122 (e.g., by threading the helical member into and along the annulus 10). Once the helical member is implanted, the guide rail 122 may be withdrawn from the helical member. For example, the guide rail may be pulled proximally to slide out of a central channel defined by the helical member, for example, as described with reference to FIG. 2E , mutatis mutandis. In some implementations, before withdrawing the guide rail 122 from the helical member, the guide rail is first detached from the guide frame 124, for example, by unwinding (e.g., unlooping) the fixation wire 144 out of the connector 133 at the distal end 132 (e.g., out of the eyelet).

[0930] In some implementations, in the delivery state, the distal end 132 of the guide rail 122 is fastened to the upstream section 121 of the guide frame. In some such implementations, release of the distal end 132 from the connected position can allow the distal end to move downstream of the central section of the guide frame in response to tightening of the loop 140.

[0931] In some implementations, in the delivery state, the distal end 132 of the guide rail 122 is fastened to the central section 125 rather than to the downstream section 127 of the guide frame 124. In some such implementations, the distal end 132 may not be released from its connected position during the transition of the guide rail to the guide device.

[0932] In some embodiments, rather than the guide rails 122 extending along the control shaft and along the exterior of the guide frame 124, the guide rails 122 of the guide assembly 120a extend distally from the control shaft 126a into the interior of the guide frame (e.g., without being exposed from the control shaft or the guide frame), and extend distally through the interior of the guide frame and out of the guide frame at the exit site 1242 so as to curve around the exterior of the guide frame.

[0933] In some implementations, the guide rails 122 extend through the control shaft 126a and out of the control shaft and into the interior of the guide frame. In some such implementations, the guide rails 122 may be coaxial within the control shaft.

[0934] In some implementations, the guide rail 122 extends along the exterior of the control shaft 126a and into the interior of the guide frame at its distal end.

[0935] The configuration of guide assembly 120a may advantageously allow the guide rail to curve more gently around the guide frame, which may facilitate improved torque application via driver 116, particularly when the driver follows the contours of the guide rail.

[0936] Furthermore, by having guide rail 122 and guide frame 124 extend out from common control shaft 126a, and / or by having guide rails extend directly into the guide frame, height h2 of guide assembly 120a within the atrium may be shorter, e.g., by allowing the distal end of control shaft 126a (e.g., and thus guide frame 124 itself) to be positioned and manipulated higher within the atrium, as compared to, e.g., some implementations of the device described with reference to guide assembly 120. This effect may be increased if catheter 128 is no longer needed as a result.

[0937] 3A, the height h1 within the atrium of the device shown with reference to guide assembly 120 (e.g., control shaft 126 extending along guide rail 122) may be greater than the height h2 of guide assembly 120a within the atrium. Similarly, having guide rail 122 and guide frame 124 extend out from a common control shaft 126a and / or having the guide rail extend directly into the guide frame may allow for a more compact delivery state of the system (e.g., by a guide assembly having a smaller cross-section during delivery).

[0938] In some implementations, the control shaft 126a is a hypotube.

[0939] In some implementations, guide assembly 120a includes spacer 130 (e.g., to prevent helical member 165 from catching guide frame 124 during threading of helical member 165 along tissue). In some implementations, spacer 130 is additionally used to actuate (e.g., expand) guide frame 124. In some implementations, spacer 130 is not present. In some such implementations, other spacing techniques may be used to shield and / or space the guide frame from the guide rails during threading of the helical member (e.g., using any of the shielding and / or spacing techniques described below).

[0940] In some implementations, the guide assembly 120a includes an actuator wire that is used to expand and / or compress the guide frame. For example, the guide assembly may include an actuator wire 136, as described with reference to, for example, FIGS. 15A-C.

[0941] In some implementations, guide assembly 120a further includes a tube 118a extending distally from control shaft 126a through the interior of guide frame 124 and out of the guide frame at exit site 1242. Guide rail 122 may extend through and out of tube 118a such that only a segment of the guide rail beyond tube 118a is exposed. Similarly, as helical member 165 is advanced over and along the guide rail, the helical member passes through the interior of guide frame 124 while within tube 118a and out at exit site 1242, only to be exposed after exiting the tube outside of the guide frame.

[0942] Thus, tube 118a may advantageously shield the guide frame and / or surrounding tissue of the heart from the sharp distal tip 167 of helical member 165 during delivery over and along the guide rails of the helical member, e.g., preventing damage to the tissue and / or capture of the guide frame. In some implementations, tube 118a may extend from the distal end of control shaft 126a (e.g., may be attached to the distal end of the control shaft, such as when a guide frame is attached to the control shaft). Alternatively, tube 118a may extend through the control shaft and out from the distal end of the control shaft.

[0943] 7 shows an implementation in which flexible sleeve 118b functions as a variation of tube 118a. In some implementations, sleeve 118b may be formed from a fabric or film, and may include a polymer (e.g., polyether block amide) or any other suitable material.

[0944] The flexibility of sleeve 118b may advantageously prevent inadvertent damage to surrounding tissue and / or the guide assembly that may occur through the traumatic distal end of a more rigid tube (e.g., by the distal end cutting tissue against which the tube contracts). Furthermore, in contrast to non-woven (e.g., metallic) tubes that may be "bent" during delivery toward the heart, sleeve 118b can resume its shape once positioned out of the delivery assembly and within the heart. Furthermore, during delivery of the tube to the heart, a flexible sleeve may be more compact than a more rigid version, for example, by having a thinner wall and / or by being more easily compressible within a sheath (e.g., sheath 112).

[0945] In some implementations, the sleeve 118b is attached to the distal end of the control shaft 126a and extends distally therefrom, hi some implementations, the sleeve 118b extends through and out of the control shaft.

[0946] In some implementations, tube 118 and / or tube 118a may be modified to include a flexible (e.g., woven) distal end. For example, tube 118 and / or 118a may be rigid (e.g., by being metal and / or plastic) but have a distal portion in the form of sleeve 118b (e.g., the portion of the tube extending out from the control shaft).

[0947] 8A and 8B, which are referenced herein, illustrate a method of delivering the helical member 165 toward the valve annulus according to some implementations. In some implementations, while the helical member advances over and along the guide rail 122 (e.g., at least a portion of the guide rail exposed out from the control shaft 126), the helical member is rotated in a direction opposite to the helical member's hand, i.e., the "unscrewing" direction.

[0948] 8B schematically illustrates how the helical member is anchored (e.g., screwed) into the tissue of the valve annulus using driver 116, rotated in a first direction. FIG. 8A schematically illustrates the previous advancement of the helical member into the tissue, with the opposite direction of the arrow indicating the helical member is rotated in a second, opposite direction. This opposite rotation during advancement may advantageously protect the guide frame and / or cardiac tissue from the sharp tip 167 of helical member 165 and / or prevent the sharp tip from undesirably catching on surrounding tissue and / or guide frame 124.

[0949] In some implementations, the helical member 165 is rotated in this second direction only once the helical member is exposed out of the delivery assembly within the heart (e.g., out of the control shaft 126). Once the helical member 165 (e.g., sharp distal tip 167) reaches (e.g., contacts) the tissue of the annulus 10, the helical member can be rotated in a “threading” direction (e.g., a first direction) to screw the helical member into the tissue ( FIG. 8B ).

[0950] In some implementations, once a user (e.g., a physician) receives feedback (e.g., tactile feedback via driver 116) that helical member 165 has reached tissue and / or the first fastener of fasteners 140, the user begins to rotate the helical member in a direction facing the tip. For example, the first fastener may prevent helical member 165 from being advanced without rotating in the first direction.

[0951] In some implementations, imaging can be performed to determine that there is contact between the tip 167 and the tissue of the annulus 10 before threading begins. In some implementations, the delivery assembly is configured to force the aforementioned counter-rotation during advancement (e.g., through the use of an interlock and / or safety mechanism on the handle 150). For example, in a first mode of the delivery assembly, an operator can operate a single control (e.g., knob) to advance the helical member distally while rotating it in an unscrewing direction, while in a second mode of the delivery assembly, the operator can operate a single control (e.g., knob), which can be the same knob, to advance the helical member distally while rotating it in a helical direction.

[0952] In some implementations, a switch 154 may be provided on the handle 150 via which an operator can switch from the first mode to the second mode, for example, once it has been determined that the helical member is properly positioned.

[0953] 9, which is now referred to, is a schematic diagram of driver 116a according to some implementations. Driver 116a may be a variation of driver 116 and may be used to implant (e.g., thread) a helical member, such as helical member 165, into and along the tissue of a body orifice (e.g., into and along the tissue of a valve annulus). Driver 116a can apply torque to the helical member while drive head 163 of the driver is engaged with a head (e.g., head 169) of the helical member. Driver 116a may be used with any of the guide assemblies described herein.

[0954] In some implementations, the driver 116a comprises and / or is formed from a tube 16 (e.g., a hypotube) that defines a drive shaft 161 along most of the tube's length, a drive head 163 at its distal end (e.g., for reversibly engaging a helical member 165), and a neck 162 (e.g., neck portion) between the drive shaft and the drive head. As described below, the neck 162 has different characteristics than the drive shaft 161 with respect to bending and application of torque.

[0955] In some implementations, the drive shaft 161 and neck 162 are formed from a single, unitary tube in a manner that imparts different properties to the drive shaft and neck. For example, during manufacturing of the driver 116a, different cutting patterns may be made along the single tube, thereby forming the drive shaft and neck (e.g., dividing the tube into them).

[0956] In some implementations, as shown, the drive shaft 161 defines a plurality of transverse slits (e.g., a first cut pattern) along its length, allowing the drive shaft to bend through deformation of the tube and slits (i.e., deformation of the material of the tube).

[0957] In some implementations, the neck 162 defines a second cut pattern along its length that segments the neck into separate, interlocking vertebrae 162a, 162b, 162c, etc. (e.g., each having a "jigsaw puzzle piece" configuration) that can articulate relative to one another. For example, as shown, the neck 162 can form a bend b1 with portions of the vertebrae along the outer periphery c1 of the arc moving apart and portions of each vertebra lying along the inner periphery c2 moving together to form the gap 18. Despite their articulation relative to one another, the vertebrae 162a-c can be rotationally locked relative to one another, thereby allowing for the transmission of torque.

[0958] In some implementations, the drive head 163 is also formed from the tube 16, e.g., the drive head is formed (e.g., cut and / or formed) from the same single tube as the drive shaft and neck. Alternatively, in some implementations, the drive head 163 is welded to the end of the tube 16, e.g., the drive head includes and / or is formed from a different piece of stock material.

[0959] In some implementations, the cut pattern of the drive shaft 161 may be particularly suited for a long transluminal path from a percutaneous entry site into a subject to the subject's heart. For example, the cut pattern may provide resilience, stability, and smoothness to the drive shaft 161, which may be advantageous for transmitting torque along a long transluminal path due to favorable (e.g., minimal) interaction between the drive shaft and other components of the delivery assembly, such as the guide rail 122 (which may be coaxially inner of the drive shaft) and the control shaft (which may be coaxially outer of the drive shaft).

[0960] The cut pattern of neck 162 may be particularly suited to the more distal region of driver 116a. For example, compared to the cut pattern of drive shaft 161, the cut pattern of neck 162 may provide greater torque strength (e.g., less susceptible to failure) under high torsion, i.e., while applying torque, when bent to a small radius of curvature, which may be advantageous for torque transmission at the distal end of the guide assembly. For example, the guide rail may be bent with a tight bend (b2 shown in FIG. 8B ) around and / or at guide frame 124, e.g., where the guide rail reaches the first fastener and / or the central section of the guide frame.

[0961] Although driver 116a is described as being usable and / or configured for use with a helical member that is threaded along tissue (e.g., so that the threaded shaft of the anchor is placed along the tissue), it should be understood that driver 116a may be used to drive (e.g., thread) any other type of tissue anchor into tissue, for example, driver 116a may be used to thread a tissue anchor longitudinally into tissue.

[0962] 10A and 10B, referenced herein, show a distal portion of control shaft 126b according to some implementations. Control shaft 126b may be a variation of any of control shafts 126 and / or 126a and may be used as a component of a guide assembly as described for those control shafts. It should be understood that the features of control shaft 126b may be provided on any of the control shafts described herein. For example, the distal portion shown in FIGS. 10A and 10B may correspond to the portion of control shaft 126a visible in FIGS. 6A-C.

[0963] In some implementations, it may be advantageous for the distal portion of the control shaft to be more flexible than the more proximal portion of the control shaft. This greater flexibility may allow the distal portion of the control shaft to assume a radius of curvature to position the guide frame 124 at the valve annulus. Thus, the distal portion may be more flexible than the more proximal portion of the control shaft.

[0964] In some implementations, the distal portion can be considered to define a flex zone 1261 where cuts in the tube give the control shaft extra flexibility. In some implementations, the control shaft can be a tube 1263, with at least the flex zone 1261 having a hypotube-type structure with multiple cuts along its length.

[0965] In some implementations, following implantation of the helical member 165 along the valve annulus, and / or once the implant 160 is fully implanted and / or contracted within the heart, the guide frame 124 is withdrawn back into the delivery assembly (e.g., within the sheath 112) and out of the heart and the subject. This may be accomplished by pulling the control shaft proximally. Thus, the control shaft may need to have sufficient tensile strength to withstand such pulling. However, for cutting patterns of hypotube-type structures, there may be a trade-off between flexibility and tensile strength.

[0966] To enhance the tensile strength of the flex zone 1261 (e.g., without significantly reducing its flexibility), the control shaft 126b can have a pair of strips 1262 extending along the flex zone. In some implementations, the strips 1262 can have a greater tensile strength than the flex zone 1261.

[0967] 10A , a first end of each strip 1262 is attached to the tube distal from the bend zone 1261, and a second end of each strip is attached to the tube proximally from the bend zone. In some implementations, at rest (e.g., before the distal portion is pulled proximally), the strips 1262 lie loosely along the bend zone 1261. In some implementations, the strips may be joined (e.g., welded) to the tube 1263 at each end of the strip.

[0968] Once implantation of helical member 165 and / or implant 160 is complete (and optionally, guide rail 122 is withdrawn proximally back into the delivery assembly), guide frame 124 is withdrawn out of the heart and into sheath 112 by pulling the control shaft. As shown in FIG. 10B , pulling the control shaft axially stretches flex zone 1261, eliminating slack in strips 1262 (e.g., tensioning the strips) that resist further stretching of the flex zone. As shown, strips 1262 can be pressed (e.g., inward) against flex zone 1261 when tensioned. The strips 1262 may thereby advantageously provide enhanced tensile strength to the flex zone 1261 (e.g., preventing failure and / or breakage of the distal portion during retraction of the guide frame into the sheath), while advantageously allowing the control shaft to benefit from the flexibility provided by the flex zone 1261 itself, for example, without unduly restricting the flexion of the flex zone.

[0969] In the embodiment shown, the distal portion of the control shaft 126b has two strips 1262. However, it should be understood that a single strip 1262, or more (e.g., three, four, or more) strips may be used.

[0970] FIG. 11, to which reference is now made, similar to FIGS. 10A and 10B, illustrates a distal portion of control shaft 126c, which, according to some implementations, defines a flexion zone 1271 having at least one reinforcing strip 1272 extending along its length. Control shaft 126c may be a variation of control shafts 126 and / or 126a and may be used as a component of a guide assembly, as described for those control shafts. It should be understood that the features of control shaft 126c may be provided on any of the control shafts described herein. For example, the distal portion shown may correspond to the portion of control shaft 126a visible in FIGS. 6A-C.

[0971] Like flex zone 1261, flex zone 1271 can be more flexible than the remainder of the control shaft. In some implementations, the control shaft can be a tube 1273, with at least flex zone 1271 having a hypotube-type structure with multiple cuts along its length.

[0972] To provide enhanced tensile strength to bend zone 1271, strips 1272 may be formed by leaving uncut axial strips along the distal portion (i.e., lying parallel to the axis of tube 1273). For example, bend zone 1271 may define a cut pattern along the tube that includes a plurality of slits distributed along the distal portion, each of which incompletely surrounds the tube, such that uncut axial strips 1272 remain extending axially along the bend zone.

[0973] In some implementations, the cut pattern defines a second uncut axial strip along the bend zone, the second strip being located on the opposite side of the bend zone from the first strip (not shown). In some implementations, the cut pattern defines three, four, or more uncut axial strips along the bend zone, each strip being spaced apart from and parallel to its adjacent strip along the bend zone.

[0974] In some implementations, the control shaft 126c may be advantageously manufactured with the strips 1272 integrated, for example, as part of the cutting pattern that defines the bending zone 1271, thereby eliminating the need for an additional manufacturing step of attaching the bending strips to the tube of the control shaft.

[0975] It should be understood that although strips 1262 and 1272 are described in the context of the control shafts described herein, they may be used to provide enhanced tensile strength to any catheter, sheath, tube (e.g., hypotube), delivery assembly, or guide assembly independent of the systems and methods described herein.

[0976] 12A and 12B, referenced herein, illustrate various guide frames according to some implementations. For simplicity, FIG. 12A illustrates guide frame 124 of guide assembly 120a (e.g., without guide rails 122 or spacers 130) to facilitate comparison with, for example, guide frame 124a shown in FIG. 12B. Guide frame 124a may be considered a variant of guide frame 124 and may be used in place of guide frame 124, mutatis mutandis. Furthermore, features of guide frame 124a may be integrated into any of the other guide frames described herein.

[0977] 12A and 12B show each guide frame attached to a control shaft 126a at the proximal end of the guide frame. As shown in FIG. 12B, guide frame 124a has an invaginated portion at its proximal end that invaginates upon deployment and / or expansion of the guide frame such that the guide frame (e.g., its proximal portion) forms an invagination 1248 that sinks into itself. Because control shaft 126a is coupled to guide frame 124a at invagination 1248, the guide assembly may require less space within the atrium. That is, once expanded, at least a portion of guide frame 124a disposed within the atrium (e.g., the upstream section) is invaginated, and control shaft 126b extends into the invagination.

[0978] In some implementations, the guide frame 124a may be formed by heat treating (e.g., shrinking) the frame to itself and / or the control shaft 126b and / or using other manufacturing methods, which may allow a larger portion of the guide frame to be positioned within the atrium, as compared to the device shown in FIG.

[0979] For example, the control shaft effective height H1" of a guide assembly including guide frame 124a may be less than the control shaft effective height H1' of a guide assembly including guide frame 124. In this context, "control shaft effective height" refers to the height of the control shaft exposed in the atrium upstream of the guide frame along the atrioventricular axis. Similarly, the deployed height H2" of guide frame 124a may be less than the deployed height H2' of guide frame 124. Note that in some implementations, invagination 1248 can provide these differences without material differences between the guide frames in their surface lengths L1. In this context, "surface length" refers to the longitudinal distance along the surface of the guide frame, measured from the control shaft to the downstream end of the guide frame.

[0980] 12A and 12B can be seen as representing a manufacturing technique for the guide frame 124a. For example, the guide frame can be formed first (FIG. 12A) and then invaginated onto itself (FIG. 12B).

[0981] In some implementations, the guide frame may optionally be heat treated to retain the invaginations 1248.

[0982] In some implementations, the invagination can be performed before or after attachment of the control shaft 126a to the guide frame.

[0983] In some implementations, the invagination may contour the proximal portion of the guide frame, for example, by bending it inward. In some implementations, the invagination 1248 is present in both the compressed / delivery state of the guide frame and the expanded state of the guide frame (e.g., when the guide assembly is in its guide device). In some implementations, in the compressed / delivery state of the guide frame 124a, the proximal portion of the guide frame is exteriorized and becomes invaginated upon expansion of the guide frame.

[0984] 13 and 14, to which reference is now made, illustrate a guide frame according to some implementations.

[0985] 13 schematically illustrates an implementation in which, in the expanded state of the guide frame 124b, the upstream section 121b of the guide frame is wider than the downstream section 127b of the guide frame according to some implementations. This can advantageously allow the upstream section 121b to act as a flange for the guide frame 124b when the guide frame is positioned on the valve. For example, in this configuration, the upstream section can abut against the upstream surface of the valve annulus, thereby preventing downstream movement of the guide frame. As shown, once expanded, the guide frame 124b assumes a mushroom-shaped configuration, with the upstream section 121b defining a ridge (e.g., shoulder) 1249 extending radially outward (e.g., across the central section of the guide frame).

[0986] In some implementations, to position the guide frame 124b within the heart, the guide frame can be expanded within the atrium and then moved downstream until the ridge 1249 abuts (e.g., is stopped by) the atrium-facing surface of the annulus.

[0987] Alternatively, in some implementations, the guide frame 124b is expanded within the ventricle downstream of the valve to be treated, and then the expanded guide frame is moved upstream through the valve (e.g., so that the ridges 1249 are compressed through tissue) and protrude radially outward across the upstream surface of the annulus.

[0988] In some implementations, the guide frame 124b can be expanded at the valve, for example, such that as the guide frame expands (and forms a mushroom shape), the ridges 1249 press against the atrium-facing surface of the annulus.

[0989] 14 shows guide frame 124c including upstream section 121c (e.g., for positioning within the atrium) and downstream section 127c (e.g., for positioning downstream of the atrium and within a ventricle), both of which are wider than central section 125c of the guide frame. For example, once expanded, upstream section 121c may define a ridge 1219 (e.g., a shoulder) extending radially outward (e.g., across central section 125c of the guide frame), and downstream section 127c may define a ridge 1279 extending radially outward (e.g., below the central section). That is, once guide frame 124c is expanded, central section 125c may have a smaller circumference than both the upstream and downstream sections, e.g., the central section, thereby assuming the form of a concave waist.

[0990] In some implementations, guide frame 124c can be expanded while central section 125c is positioned near valve annulus 10, such that the annulus is sandwiched (e.g., grasped) between the upstream and downstream sections. For example, during expansion of guide frame 124c, upstream section 121c can expand radially outward and be wedged into the atrium (e.g., pressed against the atrial-facing surface of the annulus), and downstream section 127c can expand radially outward and be wedged into the ventricle (e.g., pressed against the ventricle-facing surface of the annulus).

[0991] This sandwiching of the valve between the upstream and downstream sections may prevent slippage or unwanted movement of the guide frame relative to the tissue during anchoring of the helical member 165 along the valve annulus.

[0992] In some implementations, the upstream section 121c and the downstream section 127c are expanded independently of each other.

[0993] For example, in some implementations, before expanding the downstream section 127c, the upstream section 121c is expanded within the atrium until the ridge 1219 abuts the valve annulus (in the atrium), and the guide frame is expanded downstream toward the valve. In some such implementations, the downstream section 127c is then expanded, e.g., thereby forming the ridge 1279 within the ventricle.

[0994] Alternatively, in some implementations, before expanding the upstream section 121c, the downstream section 127c is expanded within the ventricle, and the guide frame is moved upstream toward the valve until the ridge 1279 abuts the valve annulus (within the ventricle). In some such implementations, the upstream section 121c is then expanded, for example, thereby forming the ridge 1219 within the atrium.

[0995] In some implementations, the guide apparatus may have guide rails 122 positioned along the central section 125c (e.g., just below the ridge 1219). In some implementations, the guide apparatus may have guide rails 122 positioned along the underside of the ridge 1219 in the upstream section 121c.

[0996] Reference is now made to Figures 15A-C, which illustrate implementations in which multiple actuator wires 136 may be used within the heart to both expand the guide frame and reorient the guide frame.

[0997] 15A-C show guide assembly 120b including guide frame 124, control shaft 126a, and handle 150a at its extracorporeal portion. Handle 150a can be used to control delivery of guide assembly 120b into the heart and / or to guide implantation of helical member 165 along the valve annulus (not shown).

[0998] In some implementations, the guide assembly 120b includes a guide rail (eg, guide rail 122), which is not shown for clarity.

[0999] Guide assembly 120b can be, for example, any variation of the guide assemblies described herein unless otherwise noted.

[1000] 15A-C show an implementation in which multiple actuator wires 136 are woven longitudinally along at least a portion of the guide frame, such that tensioning the actuator wires, e.g., by pulling the downstream section of the frame toward the upstream section of the frame, causes the guide frame to radially expand (as shown at the transition in FIGS. 15A and 15B), thereby shortening the frame. Similarly, the actuator wires 136 may be used to radially compress the guide frame back to its delivery state, e.g., at the end of the procedure. For example, the wires 136 may have sufficient column strength and / or stiffness such that pushing the wires distally pushes the downstream section of the frame distally, away from the upstream section of the frame, thereby elongating the frame.

[1001] In some implementations, the guide frame is configured to radially expand in response to balanced tension applied to the actuator wires. In some implementations, a control device 156a on the handle 150a can be configured to apply such balanced tension to the actuator wires to expand the guide frame. In some implementations, this is achieved by pulling or pushing the actuator wires to apply balanced tension to the wires, for example, by applying tension to the wires so that each wire has a similar or substantially equal amount of tension therein.

[1002] In some implementations, the actuator wires are attached to the distal end of the guide frame either by looping around the distal end and returning to the opposite side of the guide frame (e.g., as shown in FIG. 3B , with reference to spacer 130, mutatis mutandis), or by each end of the wire being attached to the distal end of the guide frame.

[1003] In some implementations, having multiple actuator wires 136 woven along the guide frame advantageously provides a more uniform and evenly rounded expansion of the guide frame, for example, as opposed to using only a single actuator wire, or a pair of actuator wires. For example, tension in the wires can be evenly distributed along the wires while applying balanced tension to the wires.

[1004] In some implementations, in addition to being used to expand / compress the guide assembly, the actuator wires 136 may be used to reorient and / or pivot the guide frame 124 relative to the control shaft 126a within the heart (e.g., as shown by the transition between FIG. 15B and FIG. 15C ). For example, once the guide frame 124 is positioned within the heart, a user (e.g., a physician) can adjust the position and / or orientation of the guide frame relative to the valve, for example, to better position the central section of the guide frame along the valve annulus. In some implementations, the guide frame is configured to pivot in response to differential tension applied to the actuator wires 136.

[1005] In some implementations, a control 156b on the handle 150a can be configured to apply such differential tension to the actuator wires to pivot the guide frame. In some implementations, the control 156b can be in the form of a joystick, for example, allowing a user to reorient (e.g., pivot) the guide frame within the heart. In some implementations, the control 156b has multiple actuators (e.g., knobs), each operable to pivot (e.g., rotate) the guide frame in a single plane by tensioning only a subset of the wires.

[1006] In some implementations, as described above, the handle 150a (e.g., its controller) can be configured with (i) a first actuation mode that applies balanced tension to the actuator wires and (ii) a second actuation mode that applies differential tension to the actuator wires. In some implementations, these actuation modes are provided by separate controllers. In some implementations, these actuation modes are provided by a single controller that is switchable between the first and second actuation modes. In some implementations, the guide frame is extendable independently of pivoting, and vice versa.

[1007] FIG. 16, referenced herein, illustrates an implementation in which multiple actuator wires 136a are used along the downstream section of the guide frame, e.g., not woven along the upstream section of the guide frame. The actuator wires 136a may be considered a variation of the actuator wires 136 unless otherwise noted. FIG. 16 illustrates the actuator wires 136a used in guide assembly 120c, which may be a variation of or substantially identical to any of the other guide assemblies described herein unless otherwise noted. Guide assembly 120c includes a guide frame (shown as, but not limited to, guide frame 124b) and a control shaft 126a attached to a proximal portion of the guide frame. The actuator wires 136a extend from the control shaft 126a, distally through the interior of the upstream section 121b of the guide frame, and woven along the downstream section 127b of the guide frame.

[1008] The actuator wire 136a arrangement illustrated herein can be used with any guide frame (e.g., any of the guide frames described herein). However, the actuator wire arrangement shown in FIG. 16 may be particularly advantageous when used with a guide frame having an upstream section that is wider than the central section and / or wider than the downstream section (e.g., wider than any portion and / or maximum width of the downstream section), such as described with reference to guide frame 124b (as shown) or guide frame 124c. In such implementations, having the actuator wire 136a bypass the upstream section (e.g., by extending through the interior of the guide frame rather than weaving along it) can advantageously allow the upstream section to expand toward its desired preset shape (e.g., ridge 1249) without the actuator wire interfering with the expansion (e.g., by constraining the upstream section inward). In some implementations, the weaving along the downstream section of the wire 136a provides advantages similar to those described above with reference to the actuator wire 136, e.g., applying balanced tension to the wire provides an evenly expanded guide frame, e.g., due to the force being evenly distributed across the wire.

[1009] 17, 18A and 18B, and 19A and 19B, referenced herein, illustrate various systems and methods for spacing the guide rail 122 from the guide frame 124, for example, to prevent the helical member 165 from becoming trapped on the guide frame while threading the helical member along tissue.

[1010] 17 shows a spacer 130a that extends in a serpentine manner around the central section 125 of the guide frame 124. The spacer 130a may be used in place of any of the other spacing techniques described herein and / or may be used with any of the guide frames and / or guide assemblies described herein.

[1011] Spacer 130a may be formed from a single elongated member such as a wire, ribbon, string, and / or rope that extends in a serpentine (e.g., wavy) pattern around central section 125. Spacer 130a has a width sufficient to space the guide rails from the guide frame.

[1012] The spacer 130a may be secured to the guide frame 124 by weaving intermittently along the guide frame or, as shown, via connectors 1344 (e.g., loops). In some implementations, the spacer is secured to the guide frame at each "peak" and "valley" of the spacer (i.e., its serpentine form). In some implementations, the wavelength of the spacer 130a increases during expansion of the guide frame 124, and the wavelength decreases during compression of the guide frame. In some such implementations, segments of the spacer 130a between its peaks and valleys are substantially loose relative to the guide frame 124, for example, to facilitate expansion and compression of the guide frame. In some implementations, having the spacer 130a extend only along a portion of the guide frame may advantageously provide, for example, a narrower delivery condition relative to implementations in which the spacer extends along the entire length of the delivery assembly.

[1013] 18A and 18B show an apparatus in which multiple spacers 130b are used, positioned along only a portion of the guide frame. The spacers 130b may be similar to the spacers 130, except that they do not extend along the entire length of the guide frame 124. Rather, each spacer 130b extends longitudinally along a portion of the upstream section 121, the entire central section 125, and a portion of the downstream section 127, such that each spacer "floats" along the guide frame. To accomplish this, each spacer has an upstream end 1336 that is attached to the guide frame in the upstream section and a downstream end 1338 that is attached to the guide frame in the downstream section. In some implementations, as shown in FIG. 18B , each spacer 130b curves radially away from the guide frame 124 between the ends 1336 and 1338, such that the spacers, for example in the central section 125, push the guide rails 122 and fasteners 140 radially outward and away from the guide frame, thereby preventing the helical member 165 from becoming trapped on the guide frame. Having the spacer 130b extend only along a portion of the guide frame may advantageously provide a narrower delivery condition, for example, relative to implementations in which the spacer extends the entire length of the delivery assembly.

[1014] In some implementations, rather than each spacer 130b being in the form of a wire, each spacer is in the form of a ribbon. In some implementations, each ribbon contacts its adjacent ribbon, for example, such that the ribbons collectively form a shield around the central section. In some implementations, the ribbons do not completely cover the central section, but nevertheless shield a substantial portion of the central section.

[1015] In some implementations, spacer 130b may be used in place of any of the other spacing techniques described herein and / or may be used with any of the guide frames and / or guide assemblies described herein.

[1016] 18A and 18B and 19A and 19B show spacers 130c positioned along only a portion of the guide frame. Spacers 130c may be substantially identical to spacers 130b, except that they are attached to the guide frame only at the upstream section 121 of the guide frame. For example, each spacer 130c may be attached to the upstream section 121 at its upstream end 1336a but not to the downstream section 127. In some implementations, the upstream end 1336a may be in the form of a hook that hooks onto the guide frame 124 at the upstream section 121.

[1017] In some implementations, as shown, each spacer 130c can ext...

Claims

1. 1. A system for use in cardiac tissue, comprising: Implants and 1. A delivery assembly comprising: a guide assembly having a distal portion transluminally advanceable into the heart while in a delivery state, a guide frame expandable within the heart toward an expanded state; Guide rails and a plurality of fasteners tightenable within the heart from a proximal extracorporeal portion of the delivery assembly in a manner that draws the guide rail into a guide device around at least a portion of the guide frame; a delivery assembly comprising: a driver configured to advance the implant along the guide rail within the guide device.

2. The system of claim 1 , wherein each of the fasteners is a suture.

3. 3. The system of claim 1, wherein the delivery assembly is configured to facilitate withdrawal of the guide rail and the guide frame from the heart while the implant remains within the heart.

4. The system according to any one of claims 1 to 3, wherein in the delivery state, the guide rail is arranged along the guide frame.

5. The system of any one of claims 1 to 4, wherein the guide assembly is configured to expand the guide frame before the guide rail is retracted into the guide device.

6. The system of any one of claims 1 to 5, wherein the guide frame is self-expanding.

7. The system of any one of claims 1 to 6, wherein the plurality of fasteners are tightenable independently of the expanded state of the guide frame.

8. The system of any one of claims 1 to 7, wherein the guide rail includes a series of electrodes spaced along the guide rail and electrically connected to an extracorporeal portion of the delivery assembly.

9. 9. The system of claim 1, wherein the guide assembly comprises a plurality of spacers disposed around the guide frame and configured to maintain a spacing between the guide rail and the guide frame.

10. In the guide device, the guide rail is disposed around a central section of the guide frame, the central section being longitudinally disposed between an upstream section of the frame and a downstream section of the frame; The system of claim 9 , wherein the plurality of spacers are collectively defined by an elongated member that extends in a serpentine manner around the central section of the guide frame.

11. In the guide device, the guide rail is disposed around a central section of the guide frame, the central section being longitudinally disposed between an upstream section of the frame and a downstream section of the frame; The system of claim 9 , wherein each spacer extends longitudinally along a portion of the upstream section, the entire central section, and a portion of the downstream section.

12. The system of claim 9 , wherein each of the spacers is in the form of a ribbon.

13. The system of claim 9 , wherein the spacer is operable to expand the guide frame.

14. The system of any one of claims 1 to 13, wherein each of the plurality of fasteners defines a loop around the guide rail.

15. The system of claim 14 , wherein each of the loops is looped around a respective post of the guide frame.

16. 15. The system of claim 14, wherein each of the plurality of fasteners is configured to release the guide rail by being unlooped from around the guide rail.

17. 15. The system of claim 14, wherein each fastener of the plurality of fasteners is defined by a longitudinal member extending from the extracorporeal portion to the distal site, the longitudinal member forming the loop.

18. The guide assembly includes: the guide rail is disposed along the exterior of the guide frame at the upstream section of the guide frame; and one or more fasteners of the plurality of fasteners are positionable at a location within the heart to exit the guide frame at a downstream section of the guide frame and extend along the exterior of the guide frame to the guide rail; 15. The system of claim 14, wherein the one or more fasteners are tightenable within the heart in a manner that the one or more fasteners pull the guide rail toward the downstream section, thereby drawing the guide rail into the guide device.

19. At the position of the guide assembly within the heart, the upstream section and the guide rail are upstream of the tissue; the downstream section is downstream of the tissue; 20. The system of claim 18, wherein the one or more fasteners are tightenable within the heart while the guide assembly remains in position in a manner that causes the one or more fasteners to pull the guide rail against an upstream surface of the tissue, thereby retracting the guide rail into the guide device.

20. 20. The system of claim 17, wherein in the delivered state, each of the plurality of fasteners has an exposed length that the fastener extends out from the guide frame to the guide rail, and the plurality of fasteners have different exposed lengths from one another.

21. the plurality of fasteners are arranged in series around the guide frame; 21. The system of claim 20, wherein in the delivered state, each subsequent fastener along the series has a greater exposed length than the preceding fastener.

22. 22. The system of claim 1, wherein the tissue is tissue of an annulus of the heart valve, and the guide assembly is configured to position the guide rail within the guide device and relative to the annulus.

23. one or more fasteners of the plurality of fasteners extend out from the guide frame at the downstream section of the guide frame; the guide assembly is positionable within the heart such that the guide rail is upstream of the valve annulus; 23. The system of claim 22, wherein the one or more fasteners are tightenable within the heart in a manner that the fasteners pull the guide rail against an upstream surface of the annulus, thereby drawing the guide rail against the annulus.

24. The system of any one of claims 1 to 23, wherein the implant comprises a flexible helical member defining a plurality of turns.

25. 25. The system of claim 24, wherein the helical member has a sharp distal tip.

26. the implant has a head at a proximal end of the helical member; the driver is configured to engage the implant by engaging the head; 26. The system of claim 25, wherein the helical member has a greater thickness toward the proximal end than toward the distal tip.

27. the driver is configured to anchor the implant along the tissue and on and along the guide rail by rotating the helical member in a first direction such that the distal tip penetrates the tissue; 26. The system of claim 25, wherein the helical member is deliverable onto and along the guide rail toward the tissue while rotating the helical member in a second direction, the second direction being opposite to the first direction.

28. the guide assembly is configured to position the guide rail within the guide device along the tissue surface; 25. The system of claim 24, wherein the driver is configured to anchor the implant along the tissue by threading the helical member along the guide rail and the tissue while the guide rail in the guide device is positioned along the surface of the tissue, such that a portion of each turn of the helical member is embedded in the tissue and another portion of each turn is above the surface of the tissue.

29. 29. The system of claim 28, wherein the guide rail defines a groove, and the driver is configured to anchor the implant along the tissue by threading the helical member onto and along the guide rail while the helical member is threadably engaged with and recessed within the groove.

30. the extracorporeal portion of the delivery assembly is electrically connected to the helical member and adapted to apply electrical energy to the helical member; 30. The system of claim 28, wherein the helical member is configured to contract in response to application of the electrical energy in a manner that draws the turns of the helical member closer together.

31. 30. The system of claim 28, wherein the implant further comprises a tension member.

32. 32. The system of claim 31, wherein in the guide apparatus, the tension member extends through the guide rail.

33. 33. The system of claim 32, wherein the plurality of turns surround a central channel of the helical member, and the delivery assembly is configured to retract the guide rail out of the helical member while the helical member remains anchored along the tissue, leaving the tensioning member extending through the central channel, the tensioning member configured to axially contract the helical member when tensioned.

34. 25. The system of claim 24, wherein the driver is configured to be engaged with a proximal end of the helical member and to apply a torque to the proximal end of the implant, thereby screwing the implant into the tissue.

35. 35. The system of any one of claims 1 to 34, further comprising a sheath, the distal portion of the guide assembly being transluminally advanceable to the heart while in the delivery state within the sheath.

36. 36. The system of claim 35, wherein the invaginating portion of the guide frame is configured to invaginate and form an invagination when the guide frame is expanded within the heart toward its expanded state.

37. 37. The system of any one of claims 1-36, wherein each of the fasteners is defined by a longitudinal member extending from the extracorporeal portion to the distal site, the fasteners engaged with the guide rail.

38. the guide frame defines an interior and has an exterior; 38. The system of claim 37, wherein at the distal portion, each of the longitudinal members extends from the interior, through the guide frame, to the exterior, and the fasteners are engaged with the guide rails.

39. the guide frame has a longitudinal axis and is expandable within the heart toward the expanded state by expanding radially away from the longitudinal axis; 39. The system of claim 38, wherein at the distal portion, each of the longitudinal members extends laterally from the interior portion through the guide frame to the exterior portion, and the fasteners are engaged with the guide rails.

40. In the guide device, the guide rail is placed around a central section of the guide frame, and the central section is axially disposed between an upstream section of the frame and a downstream section of the frame; the guide frame is a braided structure defined by a plurality of struts; in the central section, each strut is twisted with an adjacent strut to form a twisted pair of struts, each twisted pair of struts defining an eyelet therethrough; 40. The system of claim 39, wherein each longitudinal member extends from the interior, through a respective one of the eyelets, to the exterior, and the fastener is engaged with the guide rail.

41. the guide assembly is configured to position the guide rail within the guide device along a surface of the tissue; the implant comprises a suture; 41. The system of any one of claims 1 to 40, wherein the driver is configured to helically advance the suture along the guide rail within the guide device, thereby suturing the suture along the tissue.

42. the implant further comprises a tension member; the driver is configured to suturing the suture along the tissue such that the suture defines a series of turns along the tissue and the tension member extends along the interior of the series of turns; 42. The system of claim 41, wherein the implant is configured such that, when tensioned, the tensioning member pulls the suture, thereby adjusting the dimension of the tissue.

43. 43. The system of claim 42, wherein the tension member is disposed within a lumen of the guide rail, and the delivery assembly is configured to store the guide rail proximally out of the series of turns, leaving the tension member exposed within the series of turns.

44. the driver comprises a helical member and is adapted to thread the suture along the tissue by driving the helical member along the guide rails in the guide device such that the helical member is temporarily sutured along the tissue; The delivery assembly is configured such that the suture remains stitched along the tissue, and the tensioning member: unstitching the helical member from the tissue by helically retracting the helical member; and 43. The system of claim 42, wherein the guide rail is linearly housed so as to extend along the interior of the series of rotating parts.

45. 45. The system of claim 1, wherein the guide assembly is operably coupled to the extracorporeal portion and comprises a plurality of actuator wires woven longitudinally along at least a portion of the guide frame and attached to a downstream portion of the guide frame, such that tensioning the actuator wires from the extracorporeal portion causes the guide frame to expand radially.

46. In the guide device, the guide rail is disposed around a central section of the guide frame, the central section being longitudinally disposed between an upstream section of the frame and a downstream section of the frame; the guide assembly further comprising a control shaft extending from the extracorporeal portion and coupled to the upstream section of the guide frame; 46. ​​The system of claim 45, wherein each of the actuator wires extends from the control shaft distally through the interior of the upstream section of the guide frame and interwoven along the downstream section of the guide frame.

47. the guide assembly further comprising a control shaft extending from the extracorporeal portion and coupled to the upstream section of the guide frame; 46. ​​The system of claim 45, wherein the guide assembly is configured such that the guide frame is pivotable relative to the control shaft via differential tension of the actuator wires.

48. In the guide device, the guide rail is placed around a central section of the guide frame, and the central section is axially disposed between an upstream section of the frame and a downstream section of the frame; 48. The system of any one of claims 1 to 47, wherein the guide assembly comprises a shield disposed around the central section, such that in the guide device, the shield is disposed between the guide rail and the guide frame.

49. In the guide device, the guide rail is placed around a central section of the guide frame, and the central section is axially disposed between an upstream section of the frame and a downstream section of the frame; the guide frame is a braided structure defined by a plurality of struts; A system as claimed in any preceding claim, wherein in the central section, each strut is twisted with an adjacent strut to form a twisted pair of struts.

50. the guide rail defines an external thread; 50. The system of any one of claims 1 to 49, wherein the driver is configured to advance the implant along the guide rail by threadingly advancing the implant along the external threads.

51. 1. A system for use in cardiac tissue of a subject, comprising: Implants and 1. A delivery assembly comprising: a guide assembly including a guide rail having a leading segment, the implant being mounted on the guide rail; a delivery assembly comprising a driver engaged with the implant; The delivery assembly repeatedly: advancing the leading segment distally out of the distal end of the implant to a position along the tissue extension; and The system is configured to repeatedly secure the implant along the tissue by the driver screwing the implant into the tissue along the extension, thereby securing the leading segment to the extension of the tissue.

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