Guidance of a coil during surface anchoring

Abstract

An apparatus (20) for use with a cardiovascular system comprises an implant (50), a driver (300) for advancing the implant into tissue of the cardiovascular system, and a control unit. The control unit comprises a motorized drive (320), and a sensor. The drive is couplable to the driver at an extracorporeal portion of the apparatus, and is adapted to drive the driver. The sensor is adapted to output a signal indicative of resistance encountered by the drive during advancement, by the driver, of the implant into the tissue. The apparatus comprises an adjustment tool (400), adapted to contract the implant while the implant is implanted in the tissue. The control unit is adapted to, responsively to the signal, provide an output indicative of a maximum amount of contracting force for the adjustment tool to apply to the implant.

Description

GUIDANCE OF A COIL DURING SURFACE ANCHORINGCROSS-REFERENCES TO RELATED APPLICATIONS

[0001] The present application claims priority to US 63 / 681,085 to Avrahamov et al., filed August 8, 2024, and entitled "Guidance of a coil during surface anchoring," which is incorporated herein by reference.BACKGROUND

[0002] Hearts or portions thereof may grow enlarged under certain conditions. Dilation of an annulus of a heart valve may occur due to various heart conditions, such as an enlarged heart chamber, and may result in a leaking heart valve. A heart remodeling or annuloplasty procedure may be necessary to reshape, reinforce or tighten the heart and / or annulus.SUMMARY

[0003] This summary is meant to provide some examples and is not intended to be limiting of the scope of the disclosure in any way. For example, any feature included in an example of this summary is not required by the claims, unless the claims explicitly recite the features. Also, the features, components, steps, concepts, etc. described in examples in this summary and elsewhere in this disclosure can be combined in a variety of ways. Various features and steps as described elsewhere in this disclosure may be included in the examples summarized here.

[0004] In accordance with some implementations, a system (e.g., for use or usable with tissue of a heart, etc.) can include an implant and / or a delivery assembly. In some implementations, the delivery assembly can include a guide assembly.

[0005] In some implementations, the guide assembly can have a distal part that is transluminally advanceable to the heart while in a delivery state. In some such implementations, the guide assembly includes a guide frame. In some implementations, the guide assembly includes a guide rail. In some implementations, the guide assembly includes one or more fasteners, e.g., multiple fasteners, etc.

[0006] In some implementations, the guide frame can be intracardially expandable toward an expanded state.

[0007] In some implementations, the fasteners can be intracardially tightenable, from a proximal extracorporeal portion of the delivery assembly, in a manner that draws the guide rail into a guide arrangement around at least part of the guide frame.

[0008] In some implementations, the system includes a driver, configured to advance the implant (e.g., a distal portion of the implant, etc.) along the guide rail in the guide arrangement.

[0009] In some implementations, the delivery assembly further includes a fixation wire that is connected to a connector of the guide rail in a manner that fastens the connector to a connection location on the guide frame.

[0010] In some implementations, the fixation wire is intracardially withdrawable from the connector of the guide rail to decouple the guide rail from the guide frame.

[0011] In some implementations, the connector is an eyelet positioned on a distal end portion of the guide rail. In some implementations, the fixation wire fastens the connector to the connection location on the guide frame by extending out of the guide frame and looping through the eyelet.

[0012] In some implementations, the distal end portion comprises a cap positioned on a distal part of the guide rail.

[0013] In some implementations, the implant includes a tensile member. In some implementations, the implant includes a helical member defining multiple turns.

[0014] In some implementations, in the guide arrangement, the tensile member extends through the guide rail. In some implementations, the cap is fixedly attached to the tensile member.

[0015] In some implementations, the driver is configured to, while the guide rail in the guide arrangement is positioned along a surface of the tissue, anchor the implant along the tissue by screwing the helical member along the guide rail and the tissue such that part of each turn of the helical member becomes embedded within the tissue. In some implementations, another part of each turn lies above a surface of the tissue. In some implementations, the multiple turns circumscribe a central channel of the helical member.

[0016] In some implementations, the delivery assembly is configured to, while the helical member remains anchored along the tissue, retract the guide rail off the cap and out of the helical member, leaving the tensile member extended through the central channel.

[0017] In some implementations, the tensile member configured to, upon being tensioned, axially contract the helical member.

[0018] In some implementations, each of the fasteners is defined by a longitudinal member that extends, from the extracorporeal portion to the distal part of the guide assembly, where the fastener loops around the guide rail. In some implementations, the fastening, by the fixation wire, of the connector to the connection location inhibits the guide rail from sliding out from the fasteners.

[0019] In some implementations, in the guide arrangement, the guide rail lies around a midsection of the guide frame, the midsection disposed axially between an upstream section of the guide frame and a downstream section of the guide frame. In some implementations, in the delivery state, the connection location is disposed at the downstream section.

[0020] In some implementations, the delivery assembly is adapted to transition the guide rail towards the guide arrangement by moving the distal end portion towards the midsection, the fixation wire having sufficient slack to accommodate the moving.

[0021] In some implementations: the multiple fasteners are arranged in a series around the guide frame, a distalmost fastener of the series is connected to the distal end portion. In some implementations, the delivery assembly is adapted to move the distal end portion towards the midsection by tightening the distalmost fastener of the series.

[0022] In some implementations, the distalmost fastener of the series is connected to the distal end portion by extending through the eyelet.

[0023] In some implementations, the guide frame includes a valve member.

[0024] In some implementations, the valve member defines multiple prosthetic leaflets.

[0025] In some implementations: the guide frame defines an upstream section and a downstream section, and a concave waist disposed axially between the upstream section and the downstream section. In the expanded state of the guide frame, the waist can have a smaller circumference than both the upstream section and the downstream section. In some implementations, the valve member is positioned within the concave waist.

[0026] In some implementations, the guide frame defines an articulation zone having increased bending potential.

[0027] In some implementations, the guide frame defines multiple struts. In some implementations, at the articulation zone, the struts have increased flexibility.

[0028] In some implementations, the guide frame defines multiple struts. In some implementations, at the articulation zone, the struts have a smaller cross-section.

[0029] In some implementations: the guide frame defines an upstream section and a downstream section. In some implementations, a concave waist disposed axially between the upstream section and the downstream section. In some implementations, in the expanded state of the guide frame, the waist has a smaller circumference than both the upstream section and the downstream section.

[0030] In some implementations, the delivery assembly includes at least one constraining wire. In some implementations, the upstream section is intracardially expandable towards the expanded state while the downstream section is constrained in the delivery state by the constraining wire. In some implementations, the downstream section is intracardially releasable from the constraining wire such that the downstream section is expandable independently of the upstream section.

[0031] In some implementations, the guide assembly includes multiple actuator wires, operably coupled to the extracorporeal portion, and extending distally to the guide frame. In some implementations, each of the actuator wires extends to the upstream section of the guide frame, such that actuating the actuator wires by operation of the extracorporeal portion radially expands the upstream section.

[0032] In some implementations, the guide frame defines a plurality of struts, and each of the actuator wires extend distally through an interior of the guide frame, and are looped through a strut of the upstream section.

[0033] In some implementations, actuating the actuator wires radially expands the upstream section without expanding the downstream section.

[0034] In some implementations, the actuator wires are a first set of actuator wires, and the guide assembly further includes a second set of actuator wires that are operably coupled to the extracorporeal portion, and extend distally to the guide frame. In some implementations, each of the actuator wires of the second set extending to the downstream section of the guide frame, such that actuating the actuator wires of the second set by operation of the extracorporeal portion radially expands the downstream section.

[0035] In some implementations: in the guide arrangement, the guide rail lies around a midsection of the guide frame. In some implementations, the midsection disposed axially between an upstream section of the guide frame and a downstream section of the guideframe. In some implementations, in the expanded state of the guide frame, the downstream section is wider than the upstream section.

[0036] In some implementations, the downstream section is wider than the midsection.

[0037] In some implementations, in the expanded state, the guide frame is mushroomshaped.

[0038] In some implementations, in the expanded state, the downstream section protrudes radially outwards away from the midsection.

[0039] In some implementations: the driver is configured to implant the implant along the tissue, over and along the guide rail. In some implementations, the guide frame is positionable within the heart, in the expanded state, such that the downstream section protrudes radially outwards over a downstream surface of the tissue.

[0040] In some implementations, the guide assembly is configured to move the guide frame, in the expanded state, in an upstream direction until the downstream section abuts the downstream surface of the tissue to protrude radially outwards over the downstream surface.

[0041] In some implementations, the guide assembly is configured to move the guide frame, in the expanded state, in a downstream direction such that the downstream section squeezes past the tissue to protrude radially outwards over the downstream surface of the tissue.

[0042] In some implementations, the delivery assembly includes a sheath, and the downstream section is expandable while the upstream section is constrained within the sheath.

[0043] In some implementations, the guide frame is a laser-cut stent. In some implementations, the guide frame is cut from a nitinol tube.

[0044] In some implementations, the guide frame defines multiple hinge points therealong.

[0045] In some implementations: the guide frame defines an upstream section and a downstream section, and a concave waist disposed axially between the upstream section and the downstream section. In some implementations, in the expanded state of the guide frame, the waist has a smaller circumference than both the upstream section and the downstream section.

[0046] In some implementations, the guide frame defines an articulation zone axially along the guide frame, the articulation zone defining multiple hinge points.

[0047] In some implementations, the articulation zone is located at the upstream section of the guide frame.

[0048] In some implementations, the guide frame includes a valve member, positioned within the concave waist.

[0049] In some implementations, the valve member defines multiple prosthetic leaflets.

[0050] In some implementations, the guide assembly further includes a control shaft that extends from the extracorporeal portion and is coupled to the guide frame. In some implementations, the control shaft is coupled to the guide frame via multiple tethers that extend, from a distal portion of the control shaft, distally to the upstream section.

[0051] In some implementations, the control shaft is adapted to position the guide frame within the heart such that the guide frame is positioned nonparallel to the distal portion, facilitated by the tethers curving, from the distal portion, to the upstream section.

[0052] In some implementations, in the expanded state of the guide frame, the tethers diverge from the distal portion, distally to the upstream section.

[0053] In some implementations, the guide frame and the tethers are cut from a unitary tube.

[0054] In some implementations, the tethers are or comprise chains. In some implementations, the tethers are or comprise ribbons. In some implementations, the tethers are or comprise interconnected struts.

[0055] In some implementations, the system further includes a motor, couplable to the driver at the extracorporeal portion, and adapted to drive the driver.

[0056] In some implementations, the system further includes a sensor, adapted to output a signal indicative of resistance encountered by the motor during advancement, by the driver, of the implant along the guide rail.

[0057] In some implementations, the implant is a helical member, the driver is configured to advance the helical member along the guide rail by applying torque to the helical member. In some implementations, the sensor is adapted to output the signal responsively to an amount of torque applied to the driver by the motor.

[0058] In some implementations, the system further includes a control unit, adapted to receive the signal and to provide an output indicative of the signal.

[0059] In some implementations, the implant includes a helical member. In some implementations, the guide assembly is configured to position, along a surface of the tissue, the guide rail in the guide arrangement.

[0060] In some implementations, the driver is configured to, while the guide rail in the guide arrangement is positioned along the surface of the tissue, anchor the implant along the tissue by screwing the helical member along the guide rail and the tissue such that part of each turn of the helical member becomes embedded within the tissue, and another part of each turn lies above a surface of the tissue. In some implementations, the output is indicative of a path of the helical member along the tissue.

[0061] In some implementations, the guide assembly is configured to position, along a surface of the tissue, the guide rail in the guide arrangement. In some implementations, the driver is configured to, while the guide rail in the guide arrangement is positioned along the surface of the tissue, anchor the implant along the tissue and the guide rail. In some implementations, the output is indicative of a tissue type of the tissue.

[0062] In some implementations: the guide assembly is configured to position, along a surface of the tissue, the guide rail in the guide arrangement. In some implementations, the driver is configured to, while the guide rail in the guide arrangement is positioned along the surface of the tissue, anchor the implant along the tissue and the guide rail. In some implementations, the output is indicative of a position of the implant within the heart.

[0063] In some implementations, responsively to receiving a signal from the sensor indicative of a significant change in resistance encountered by the driver. In some implementations, the control unit is adapted to provide an alert.

[0064] In some implementations, responsively to receiving a signal from the sensor indicative of a sharp increase of resistance encountered by the driver. In some implementations, the control unit is adapted to provide an alert.

[0065] In some implementations, the control unit is adapted to control the motor. In some implementations, responsively to receiving a signal from the sensor indicative of a significant change in resistance encountered by the driver, the control unit is adapted to automatically stop the motor.

[0066] In some implementations, responsively to receiving a signal from the sensor indicative of a sharp increase of resistance encountered by the driver, the control unit is adapted to automatically stop the motor.

[0067] In some implementations, the control unit is adapted to determine, responsively to the signal, a change in resistance encountered by the motor over time. In some implementations, the control unit is adapted to responsively provide the output.

[0068] In some implementations, the control unit is adapted to provide the output via a user interface.

[0069] In some implementations, the control unit is adapted to provide a graph indicative of the change in resistance over time, via the user interface.

[0070] In some implementations, the implant further includes a tensile member. In some such implementations, the system further includes a tensioning tool that is configured to contract the tissue along which the implant is anchored by applying tension to the tensile member.

[0071] In some implementations, the control unit is adapted to provide an indication indicative of a maximum amount of tensioning force for the tensioning tool to apply to the tensile member, responsively to the signal.

[0072] In some implementations, the implant further includes a tensile member. In some implementations, the system further includes a tensioning tool that is configured to contract the tissue along which the implant is anchored by applying tension to the tensile member.

[0073] In some implementations, the motor is adapted to apply the tension via the tensioning tool. In some implementations, the control unit is adapted to apply the tension responsively to the output.

[0074] In some implementations, in the guide arrangement, the tensile member extends through the guide rail.

[0075] In some implementations, the implant includes a helical member.

[0076] In some implementations, the guide assembly is configured to position, along a surface of the tissue, the guide rail in the guide arrangement. In some implementations, the driver is configured to, while the guide rail in the guide arrangement is positioned along the surface of the tissue, anchor the implant along the tissue by screwing the helical member along the guide rail and the tissue such that part of each turn of the helical member becomes embedded within the tissue, and another part of each turn lies above a surface of the tissue. In some implementations, the multiple turns circumscribe a central channel of the helical member.

[0077] In some implementations, the delivery assembly is configured to, while the helical member remains anchored along the tissue, retract the guide rail out of the helical member, leaving the tensile member extended through the central channel. In some implementations, the tensile member configured to, upon being tensioned, axially contract the helical member.

[0078] In some implementations, the system further includes a stopper coupled to a distal end of the tensile member, such that tension applied to the tensile member longitudinally contracts the helical member by the stopper inhibiting sliding of the tensile member through the central channel.

[0079] In some implementations, the tensioning tool that is configured to contract the tissue along which the helical member is anchored by axially contracting the helical member.

[0080] In some implementations, the guide assembly includes multiple actuator wires, operably coupled to the extracorporeal portion, extending distally through an interior of the guide frame, and attached to a downstream section of the guide frame, such that tensioning the actuator wires from the extracorporeal portion radially expands the guide frame.

[0081] In some implementations, in the guide arrangement, the guide rail lies around a midsection of the guide frame. In some implementations, the midsection disposed longitudinally between an upstream section of the guide frame and the downstream section of the guide frame.

[0082] In some implementations, the guide assembly further includes a control shaft that extends from the extracorporeal portion. In some implementations, the control shaft is coupled to the upstream section of the guide frame. In some implementations, the guide frame defines multiple struts.

[0083] In some implementations, each of the actuator wires extends, from the control shaft, distally through the interior of the guide frame to the downstream section where the respective actuator wire loops around a respective strut of the guide frame.

[0084] In some implementations, the guide assembly includes exactly three actuator wires.

[0085] In some implementations, each of the actuator wires extends from the extracorporeal portion, distally along the control shaft. In some implementations, each of the actuator wires extends from a distal end of the control shaft, distally through the interior of the guide frame to the downstream section.

[0086] In some implementations, at the downstream section, each actuator wire loops around a respective strut, returns, from the respective strut, proximally through the interior of the guide frame to the control shaft. In some implementations, each of the actuator wires, from the distal end of the control shaft, extends proximally along the control shaft to the extracorporeal portion.

[0087] In some implementations, the guide assembly includes exactly three actuator wires, such that the actuator wires form a tripod-like arrangement within the guide frame.

[0088] In some implementations, each of the actuator wires extends along an exterior of the control shaft.

[0089] In some implementations, each of the actuator wires extends along the control shaft within a lumen of the control shaft.

[0090] In some implementations, in the expanded state of the guide frame, at least part of the upstream section is wider than the downstream section.

[0091] In some implementations, in the expanded state of the guide frame, at least part of the upstream section is wider than the midsection.

[0092] In some implementations, the guide assembly is configured such that the guide frame is pivotable with respect to the control shaft via differential tensioning of the actuator wires.

[0093] In some implementations, the extracorporeal portion includes at least one controller to which the actuator wires are operatively coupled. In some implementations, the extracorporeal portion is configured to differentially actuate the actuator wires via actuation of the at least one controller.

[0094] In some implementations, the guide frame is configured to radially expand responsively to balanced tension in the actuator wires. In some implementations, the extracorporeal portion is configured to apply the balanced tension to the actuator wires.

[0095] In some implementations, the at least one controller is configured with a first actuation mode that applies the balanced tension to the actuator wires. In some implementations, the at least one controller is configured with a second actuation mode that applies the differential tension to the actuator wires.

[0096] In some implementations, each of the fasteners is defined by a longitudinal member that extends, from the extracorporeal portion to the distal part, where the fastener is engaged with the guide rail.

[0097] In some implementations, the guide frame defines an interior and has an exterior. In some implementations, at the distal part, each of the longitudinal members extends from the interior, through the guide frame to the exterior, where the fastener is engaged with the guide rail.

[0098] In some implementations: the guide assembly includes multiple rods.

[0099] In some implementations, each of the multiple rods defining a pair of lumens. In some implementations, each of the longitudinal members extends, distally through a first lumen of a respective rod, and, at the distal part, out of the first lumen to loop around the guide rail, and proximally back into a second lumen of the respective rod, and proximally through the second lumen.

[0100] In some implementations, each rod defines a pair of secondary rods, each of the secondary rods defining a lumen of the pair.

[0101] In some implementations, each rod defines a singular tubular structure defining the pair of lumens therethrough.

[0102] In some implementations, for each rod, the first lumen and the second lumen define a distal opening that is disposed at an inner surface of the guide frame.

[0103] In some implementations: the guide frame defines multiple struts, for each rod, the rod extends through the interior of the guide frame to an interior surface of the guide frame where the first lumen and the second lumen diverge to curve around a respective strut of the guide frame. In some implementations, each of the first lumen and the second lumen defines a distal opening that is disposed at an exterior surface of the guide frame.

[0104] In some implementations, the multiple rods are flexible.

[0105] In some implementations, the multiple rods are longitudinally incompressible.

[0106] In some implementations, the multiple rods extend distally within the interior.

[0107] In some implementations, the guide assembly includes multiple spacers, arranged around the guide frame, and configured to maintain a spacing between the guide rail and the guide frame.

[0108] In some implementations, in the guide arrangement, the guide rail lies around a midsection of the guide frame, the midsection disposed longitudinally between an upstream section of the guide frame and a downstream section of the guide frame. In someimplementations, each spacer extends longitudinally alongside part of the upstream section, the entire midsection, and part of the downstream section.

[0109] In some implementations, each of the spacers is a wire.

[0110] In some implementations, each of the spacers is a hollow tube that defines a lumen therethrough. In some implementations, for each spacer, a respective tether extends, from the upstream section where the tether is attached to the guide frame, through the respective lumen, and out of the lumen where the tether is attached to the downstream section.[OHl] In some implementations, the guide frame defines multiple struts. In some implementations, for each spacer, the spacer is attached to the upstream section and the downstream section by the respective tether of the spacer being tied to respective struts of the guide frame.

[0112] In some implementations, each one of the tethers is a string.

[0113] In some implementations, for each spacer, at the downstream section, the spacer enters the guide frame and extends across an interior of the guide frame to an opposite side of the guide frame, where the spacer is attached thereto.

[0114] In some implementations, within the interior of the guide frame, the spacers overlap to form a spiral arrangement.

[0115] In some implementations, the guide assembly includes exactly twelve spacers.

[0116] In accordance with some implementations, a method for use with a real or simulated heart of a real or simulated subject includes transluminally advancing a guide frame to the heart. In some implementations, this is done while the guide frame is secured to a guide rail via one or more or multiple fasteners that extend out of the guide frame to the guide rail.

[0117] In some implementations, the method includes expanding the guide frame within the heart.

[0118] In some implementations, the method includes drawing the guide rail into a guide arrangement around at least a part of the guide frame by tightening at least one of the multiple fasteners.

[0119] In some implementations, the method includes imaging the guide frame within the heart to determine a relative position of the guide frame with respect to the heart.

[0120] In some implementations, the method includes, responsively to the determining, identifying a suitability of the position of the guide frame for anchoring an implant into tissue of the heart by screwing the implant over and along the guide rail.

[0121] In some implementations, in the guide arrangement, the guide rail lies around a midsection of the guide frame, the midsection disposed axially between an upstream section of the guide frame and a downstream section of the guide frame.

[0122] In some implementations, transluminally advancing the guide frame to the heart includes transluminally advancing the guide frame to the heart using a control shaft that is coupled to the upstream section of the guide frame.

[0123] In some implementations, expanding the guide frame within the heart includes expanding the guide frame by extracorporeally tensioning multiple actuator wires that extend, from the control shaft to the guide frame. In some implementations, the multiple actuator wires extend distally through an interior of the upstream section of the guide frame to a downstream section of the guide frame around which the respective actuator wire is looped. In some implementations, the multiple actuator wires extend proximally back through the interior of the guide frame to the control shaft.

[0124] In some implementations, in the guide arrangement, the guide rail lies around a midsection of the guide frame, the midsection disposed axially between an upstream section of the guide frame and a downstream section of the guide frame. In some implementations, expanding the guide frame within the heart includes expanding the downstream section downstream of the tissue such that the downstream section defines a ridge. In some implementations, the method includes positioning the ridge against a downstream-facing surface of the tissue by pulling the guide frame proximally until the ridge abuts against the downstream-facing surface of the tissue.

[0125] In some implementations, the heart includes an atrium, a ventricle downstream of the atrium, and a valve therebetween, the valve defining an orifice, an annulus circumscribing the orifice. In some implementations, the tissue is tissue of the annulus. In some implementations, expanding the downstream section downstream of the tissue includes expanding the downstream section within the ventricle.

[0126] In some implementations, positioning the ridge against the downstream-facing surface of the tissue includes positioning the ridge against a ventricular-facing surface of theannulus, such that the downstream section protrudes radially over the ventricular-facing surface.

[0127] In some implementations, the method further includes, subsequently to positioning the ridge against the downstream-surface of the tissue, expanding the upstream section upstream of the tissue, within the heart.

[0128] In some implementations, expanding the upstream section includes expanding the upstream section such that the upstream section presses against an upstream surface of the tissue.

[0129] In some implementations, expanding the upstream section includes expanding the upstream section such that the guide frame defines a concave waist disposed axially between the upstream section and the downstream section. In some implementations, the waist can have a smaller circumference than both the upstream section and the downstream section.

[0130] In some implementations, expanding the downstream section downstream of the tissue includes expanding the downstream section downstream of the tissue while the upstream section is constrained within a catheter.

[0131] In some implementations, expanding the upstream section within the atrium includes releasing the upstream section from the catheter such that the upstream section self-expands within the heart.

[0132] In some implementations, expanding the upstream section within the atrium includes tensioning actuator wires that are attached to the upstream section to expand the upstream section.

[0133] In some implementations, expanding the guide frame within the heart includes partially expanding the guide frame within the heart, while the guide frame is suspended within the heart upstream of the tissue.

[0134] In some implementations, drawing the guide rail into a guide arrangement around at least a part of the guide frame includes drawing the guide rail into a guide arrangement around the partially expanded guide frame, while the guide frame remains suspended within the heart, upstream of the tissue.

[0135] In some implementations, the method further includes, subsequently to drawing the guide rail into a guide arrangement around at least a part of the guide frame, moving thepartially expanded guide frame downstream within the heart, until the guide rail abuts the tissue.

[0136] In some implementations, while the guide rail is positioned along the tissue in the guide arrangement, the method further includes fully expanding the guide frame.

[0137] In some implementations, fully expanding the guide frame while the guide rail is positioned along the tissue in the guide arrangement includes fully expanding the guide frame while pushing the guide frame distally to maintain the guide rail against the tissue.

[0138] In some implementations, in the guide arrangement, the guide rail lies around a midsection of the guide frame, the midsection disposed axially between an upstream section of the guide frame and a downstream section of the guide frame.

[0139] In some implementations, transluminally advancing the guide frame to the heart includes transluminally advancing the guide frame to the heart using a control shaft that is coupled to the upstream section of the guide frame.

[0140] In some implementations, imaging the guide frame within the heart to determine a relative position of the guide frame with respect to the heart includes imaging the guide frame while pushing the control shaft distally, to determine a movement of the upstream section.

[0141] In some implementations, in the expanded state of the guide frame, the upstream section protrudes radially outwards over an upstream surface of the tissue. In some implementations, imaging the guide frame while pushing the control shaft distally, to determine a movement of the upstream section includes imaging the guide frame while pushing the control shaft distally, to determine whether the protruding of the upstream section over the upstream surface of the tissue prevents distalward movement.

[0142] In some implementations, imaging the guide frame while pushing the control shaft distally, to determine a movement of the upstream section includes imaging the guide frame while pushing the control shaft distally, to determine whether the upstream section becomes inverted around the control shaft.

[0143] In some implementations, in the guide arrangement, the guide rail lies around a midsection of the guide frame, the midsection disposed axially between an upstream section of the guide frame and a downstream section of the guide frame, and / or imaging the guide frame within the heart to determine a relative position of the guide frame with respect to theheart includes imaging the downstream section over at least a portion of a cardiac cycle of the subject, to determine a movement of the downstream section responsively to the cardiac cycle.

[0144] In some implementations, the heart includes a valve, the valve including a plurality of leaflets, and an annulus, the tissue being tissue of the annulus. In some implementations, imaging the downstream section over at least a portion of the cardiac cycle includes imaging the downstream section over at least a portion of a systolic phase of the cardiac cycle, to determine whether the downstream section becomes radially compressed, responsively to leaflets of the valve converging medially within the valve.

[0145] In some implementations, the guide frame defines a concave waist disposed axially between the upstream section and the downstream section. In some implementations, expanding the guide frame within the heart includes expanding the guide frame within the heart such that the waist has a smaller circumference than both the upstream section and the downstream section.

[0146] In accordance with some implementations, a system and / or an apparatus for use with a cardiovascular system includes an implant, a driver and a motor. In some implementations, the system / apparatus comprises one or more sensors. In some implementations, the system / apparatus comprises one or more adjustment tools.

[0147] In some implementations, the driver can be for advancing the implant into tissue of the cardiovascular system.

[0148] In some implementations, the motor can be couplable to the driver at an extracorporeal portion of the system / apparatus. In some implementations, the motor can be adapted to drive the driver.

[0149] In some implementations, the sensor can be adapted to output a signal indicative of resistance encountered by the motor during advancement, by the driver, of the implant into the tissue.

[0150] In some implementations, the adjustment tool can be adapted to contract the implant while the implant is implanted in the tissue.

[0151] In some implementations, the system / apparatus includes a control unit. In some implementations, the control unit is adapted to receive the signal and to provide, responsively to the signal, an output.

[0152] In some implementations, the output is indicative of a maximum amount of contracting force for the adjustment tool to apply to the implant.

[0153] In accordance with some applications, a system and / or an apparatus (which can be used with a valve of a heart, e.g., of a living subject or of a simulation) includes an implant, a driver, and / or a control unit. The driver can be used for advancing the implant into tissue of the cardiovascular system. The control unit can include a motor, a sensor, a data- processing system (DPS), and / or an adjustment tool.

[0154] In some implementations, the motor can be couplable to the driver at an extracorporeal portion of the apparatus, and adapted to drive the driver.

[0155] In some implementations, the sensor can be adapted to output a signal indicative of resistance encountered by the motor during advancement, by the driver, of the implant into the tissue.

[0156] In some implementations, the data-processing system can be adapted to receive the signal.

[0157] In some implementations, the adjustment tool can be adapted to contract the implant while the implant is implanted in the tissue.

[0158] In some implementations, the DPS can be adapted to, responsively to the signal, provide an output indicative of a maximum amount of contracting force for the adjustment tool to apply to the implant.

[0159] In some implementations: (i) the apparatus further includes a guide assembly that includes a guide rail, (ii) the guide assembly is configured to position the guide rail along a surface of the tissue, in a guide arrangement, and / or (iii) the driver is configured to, while the guide rail in the guide arrangement and positioned along the surface of the tissue, anchor the implant along the tissue and the guide rail.

[0160] In some implementations, the output is indicative of a tissue type of the tissue.

[0161] In some implementations, the implant is a helical member. In some implementations, the driver is configured to advance the helical member into the tissue by applying torque to the helical member. In some implementations, the sensor is adapted to output the signal responsively to an amount of torque applied to the driver by the motor.

[0162] In some implementations, the implant includes a helical member. In some implementations, the driver is configured to, while the guide rail in the guide arrangement ispositioned along the surface of the tissue, anchor the implant along the tissue by screwing the helical member along the guide rail and the tissue such that part of each turn of the helical member becomes embedded within the tissue, and another part of each turn lies above a surface of the tissue. In some implementations, the output is indicative of a path of the helical member along the tissue.

[0163] In some implementations, the output is indicative of a position of the implant within the cardiovascular system.

[0164] In some implementations, responsively to receiving a signal from the sensor indicative of a change in resistance encountered by the driver, the control unit is adapted to provide an alert. The change may correspond to a predetermined amount of change.

[0165] In some implementations, responsively to receiving a signal from the sensor indicative of an increase of resistance encountered by the driver, the control unit is adapted to provide an alert. The increase of resistance that triggers the alert may correspond to a predetermined increase of resistance. In some implementations, the increase of resistance that triggers the alert may correspond to a predetermined increase of resistance across a predetermined amount of time.

[0166] In some implementations, the control unit is adapted to control the motor. In some implementations, responsively to receiving a signal from the sensor indicative of a change in resistance encountered by the driver, the control unit is adapted to automatically stop the motor. The change may correspond to a predetermined amount of change.

[0167] In some implementations, responsively to receiving a signal from the sensor indicative of an increase of resistance encountered by the driver, the control unit is adapted to automatically stop the motor. The increase of resistance that triggers the alert may correspond to a predetermined increase of resistance. In some implementations, the increase of resistance that triggers the alert may correspond to a predetermined increase of resistance across a predetermined amount of time.

[0168] In some implementations, the control unit is adapted to determine, responsively to the signal, a change in resistance encountered by the motor over time, and to responsively provide the output.

[0169] In some implementations, the control unit is adapted to provide the output via a user interface.

[0170] In some implementations, the control unit is adapted to provide a graph indicative of the change in resistance over time, via the user interface.

[0171] In some implementations: (i) the implant further includes a tensile member, and / or (ii) the adjustment tool is adapted to contract the tissue along which the implant is anchored by applying tension to the tensile member such that the implant becomes contracted.

[0172] In some implementations: (i) the motor is adapted to apply the tension via the adjustment tool, and / or (ii) the control unit is adapted to apply the tension responsively to the output.

[0173] In some implementations: (i) the apparatus further includes a guide assembly that includes a guide rail, (ii) the guide assembly is configured to position the guide rail along a surface of the tissue, in a guide arrangement, (iii) the driver is configured to, while the guide rail in the guide arrangement is positioned along the surface of the tissue, anchor the implant along the tissue and the guide rail, and / or (iv) in the guide arrangement, the tensile member extends through the guide rail.

[0174] In some implementations: (i) the implant includes a helical member, (ii) the driver is configured to anchor the implant along the tissue by screwing the helical member along the tissue such that: (a) part of each turn of the helical member becomes embedded within the tissue, and another part of each turn lies above a surface of the tissue, (b) the multiple turns circumscribe a central channel of the helical member, and / or (c) the tensile member extends through the central channel, and / or (iii) the tensile member is configured to, upon being tensioned, axially contract the helical member.

[0175] In some implementations, the apparatus further includes a stopper coupled to a distal end of the tensile member, such that tension applied to the tensile member longitudinally contracts the helical member by the stopper inhibiting sliding of the tensile member through the central channel.

[0176] In some implementations, the adjustment tool is configured to contract the tissue along which the helical member is anchored by axially contracting the helical member.

[0177] In accordance with some applications, a system and / or an apparatus (which can be used with a valve of a heart, e.g., of a living subject or of a simulation) includes (i) an implant, (ii) a guide assembly, (iii) a driver, and / or (iv) a control unit.

[0178] In some implementations, the guide assembly has a distal part that is transluminally advanceable to the cardiovascular system while in a delivery state, the guide assembly including a guide rail that is positionable along tissue of the cardiovascular system.

[0179] In some implementations, the driver is adapted to screw the implant into the tissue by advancing the implant over and along the guide rail in a first direction.

[0180] In some implementations, the control unit includes: (a) a motor, couplable to the driver at an extracorporeal portion of the apparatus, and adapted to drive the driver, and / or (b) a sensor, adapted to output a signal indicative of resistance encountered by the motor during advancement, by the driver, of the implant into the tissue.

[0181] There is further provided, in accordance with some implementations, an apparatus for use with a cardiovascular system, the apparatus including: (i) an implant, (ii) a guide assembly, (iii) a driver, and / or (iv) a control unit,

[0182] In some implementations, the guide assembly includes a distal part that is transluminally advanceable to the cardiovascular system while in a delivery state. In some implementations, the guide assembly including a guide rail that is positionable along tissue of the cardiovascular system.

[0183] In some implementations, the driver is adapted to screw the implant into the tissue by advancing the implant over and along the guide rail in a first direction.

[0184] In some implementations, the control unit includes: (a) a motor, couplable to the driver at an extracorporeal portion of the apparatus, and adapted to drive the driver, (b) a sensor, adapted to output a signal indicative of resistance encountered by the motor during advancement, by the driver, of the implant into the tissue, (c) a data-processing system adapted to: (I) receive the signal, (II) operate the motor to reverse along the guide rail in a second direction that is opposite to the first direction, and / or (III) operate the motor to subsequently re-advance the implant over and along the guide rail in the first direction.

[0185] In accordance with some applications, a system and / or an apparatus (which can be used with a valve of a heart, e.g., of a living subject or of a simulation) includes (i) an implant; (ii) a driver, (iii) an adjustment tool; and / or (iv) a control unit.

[0186] In some implementations, a driver for driving the implant into tissue of the cardiovascular system. In some implementations, the adjustment tool is adapted to contractthe tissue by applying a contracting force to the implant while the implant remains in the tissue

[0187] In some implementations, the control unit comprises a motorized drive, couplable to the driver at an extracorporeal portion of the apparatus, and adapted to drive the driver to drive the implant into the tissue. In some implementations, the control unit comprises a sensor, adapted to sense resistance encountered by the drive during the driving of the implant into the tissue, and to provide a signal indicative of the resistance. In some implementations, the control unit comprises a data-processing system adapted to receive the signal and, responsively to the signal, provide an output indicative of a magnitude limit for the contracting force to be applied by the adjustment tool.

[0188] In some implementations, the apparatus further includes a guide assembly that includes a guide rail. In some implementations, the guide assembly is configured to position the guide rail along a surface of the tissue, in a guide arrangement. In some implementations, the driver is configured to, while the guide rail in the guide arrangement is positioned along the surface of the tissue, anchor the implant along the tissue and the guide rail.

[0189] In some implementations, the implant includes a helical member. In some implementations, the driver is configured to, while the guide rail in the guide arrangement is positioned along the surface of the tissue, anchor the implant along the tissue by screwing the helical member along the guide rail and the tissue such that part of each turn of the helical member becomes embedded within the tissue, and another part of each turn lies above a surface of the tissue. In some implementations, the output is indicative of a path of the helical member along the tissue.

[0190] In some implementations, the output is indicative of a tissue type of the tissue.

[0191] In some implementations, the implant is a helical member defining multiple turns. In some implementations, the driver is configured to advance the helical member into the tissue by applying torque to the helical member. In some implementations, the sensor is adapted to output the signal responsively to an amount of torque applied to the driver by the drive.

[0192] In some implementations, the adjustment tool is adapted to contract the tissue by axially contracting the implant.

[0193] In some implementations, the adjustment tool is adapted to contract the tissue by axially contracting the helical member such that the multiple turns move towards each other.

[0194] In some implementations, the output is indicative of a position of the implant within the cardiovascular system.

[0195] In some implementations, responsively to receiving a signal from the sensor indicative of a significant change in resistance encountered by the driver, the control unit is adapted to provide an alert.

[0196] In some implementations, responsively to receiving a signal from the sensor indicative of a sharp increase of resistance encountered by the driver, the control unit is adapted to provide an alert.

[0197] In some implementations, the data-processing system is adapted to control the drive. In some implementations, responsively to receiving a signal from the sensor indicative of a significant change in resistance encountered by the driver, the data-processing system is adapted to automatically stop the drive.

[0198] In some implementations, responsively to receiving a signal from the sensor indicative of a sharp increase of resistance encountered by the driver, the data-processing system is adapted to automatically stop the drive.

[0199] In some implementations, the control unit is adapted to determine, responsively to the signal, a change in resistance encountered by the drive over time, and to responsively provide the output.

[0200] In some implementations, the control unit is adapted to provide the output via a user interface.

[0201] In some implementations, the control unit is adapted to provide a graph indicative of the change in resistance over time, via the user interface.

[0202] In some implementations, the implant further includes a tensile member. In some implementations, the adjustment tool is adapted to contract the tissue along which the implant is anchored by applying tension to the tensile member such that the implant becomes contracted.

[0203] In some implementations, the drive is adapted to apply the tension via the adjustment tool. In some implementations, the control unit is adapted to apply the tension responsively to the output.

[0204] In some implementations, the apparatus further includes a guide assembly that includes a guide rail. In some implementations, the guide assembly is configured to positionthe guide rail along a surface of the tissue, in a guide arrangement. In some implementations, the driver is configured to, while the guide rail in the guide arrangement is positioned along the surface of the tissue, anchor the implant along the tissue and the guide rail. In some implementations, in the guide arrangement, the tensile member extends through the guide rail.

[0205] In some implementations, the implant includes a helical member defining multiple turns. In some implementations, the driver is configured to anchor the implant along the tissue by screwing the helical member along the tissue such that: (i) part of each turn of the helical member becomes embedded within the tissue, and another part of each turn lies above a surface of the tissue, (ii) the multiple turns circumscribe a central channel of the helical member, and / or (iii) the tensile member extends through the central channel. In some implementations, the tensile member is configured to, upon being tensioned, axially contract the helical member.

[0206] In some implementations, the tensile member is configured to, upon being tensioned, axially contract the helical member such that multiple turns move towards each other.

[0207] In some implementations, the apparatus further includes a stopper coupled to a distal end of the tensile member, such that tension applied to the tensile member longitudinally contracts the helical member by the stopper inhibiting sliding of the tensile member through the central channel.

[0208] In some implementations, the adjustment tool is configured to contract the tissue along which the helical member is anchored by axially contracting the helical member.

[0209] In accordance with some applications, a system and / or an apparatus (which can be used with a valve of a heart, e.g., of a living subject or of a simulation) includes (i) an implant; (ii) a guide assembly; (iii) a driver; and / or (iv) a control unit.

[0210] In some implementations, the guide assembly includes a distal part that is transluminally advanceable to the cardiovascular system while in a delivery state, the guide assembly including a guide rail that is positionable along tissue of the cardiovascular system.

[0211] In some implementations, the driver can drive the implant into the tissue by advancing the implant over and along the guide rail in a first direction.

[0212] In some implementations, the control unit includes a motorized drive, couplable to the driver at an extracorporeal portion of the apparatus, and adapted to drive the driver todrive the implant into the tissue. In some implementations, the control unit includes a sensor, adapted to sense resistance encountered by the drive during the driving of the implant into the tissue, and to provide a signal indicative of the resistance.

[0213] In accordance with some applications, a system and / or an apparatus (which can be used with a valve of a heart, e.g., of a living subject or of a simulation) includes (i) an implant; (ii) a guide assembly; (iii) a driver; and / or (iv) a control unit.

[0214] In some implementations, the guide assembly includes a distal part that is transluminally advanceable to the cardiovascular system while in a delivery state, the guide assembly including a guide rail that is positionable along tissue of the cardiovascular system.

[0215] In some implementations, the driver can screw the implant into the tissue by advancing the implant over and along the guide rail in a forward direction.

[0216] In some implementations, the control unit includes a motorized drive, couplable to the driver at an extracorporeal portion of the apparatus, and adapted to drive the driver. In some implementations, the control unit includes a sensor, adapted to sense resistance encountered by the drive during the driving of the implant into the tissue, and to output a signal indicative of an obstruction event encountered by the drive during the driving, the resistance event being indicative of a tip of the implant encountering an obstruction. In some implementations, the control unit includes a data-processing system adapted to perform a release procedure responsively to the signal, the release procedure including: (i) reversing the drive to unscrew the implant along the guide rail in a reverse direction such that the tip reverses away from the obstruction, and / or (ii) subsequently operating the drive to re-screw the implant over and along the guide rail in the forward direction such that the tip passes the obstruction.

[0217] In accordance with some applications, a system and / or an apparatus (which can be used with a valve of a heart, e.g., of a living subject or of a simulation) includes (a) a guide rail; (b) a frame; (c) a flexible helical member defining multiple turns; and / or (d) a driver.

[0218] In some implementations, the system includes a plurality of loops adapted to intracardially position the guide rail into a guide arrangement circumferentially around the frame.

[0219] In some implementations, the driver is adapted to, while the guide rail lies along a surface of a tissue of the valve, anchor the helical member to the tissue, by screwing the helical member over and along the guide rail around the frame, such that part of each turn ofthe helical member becomes embedded within the tissue and another part of each turn lies above the surface of the tissue.

[0220] In some implementations, the frame includes multiple leaflets.

[0221] In some implementations, the guide frame is a laser-cut stent.

[0222] In some implementations, the guide frame defines multiple hinge points therealong.

[0223] In some implementations, the guide frame is cut from a nitinol tube.

[0224] In some implementations: (i) the guide frame defines an upstream section and a downstream section, and a concave waist disposed axially between the upstream section and the downstream section, and / or (ii) in the expanded state of the guide frame, the waist has a smaller circumference than both the upstream section and the downstream section.

[0225] In some implementations, the guide frame defines an articulation zone axially along the guide frame, the articulation zone defining multiple hinge points.

[0226] In some implementations, the articulation zone is located at the upstream section of the guide frame.

[0227] In some implementations, the guide frame includes a valve member, positioned within the concave waist and defining the multiple leaflets.

[0228] In some implementations: (i) the guide assembly further includes a control shaft that extends from the extracorporeal portion and is coupled to the guide frame, and / or (ii) the control shaft is coupled to the guide frame via multiple tethers that extend, from a distal portion of the control shaft, distally to the upstream section.

[0229] In some implementations, the control shaft is adapted to position the guide frame within the heart such that the guide frame is positioned nonparallel to the distal portion, facilitated by the tethers curving, from the distal portion, to the upstream section.

[0230] In some implementations, in the expanded state of the guide frame, the tethers diverge from the distal portion, distally to the upstream section.

[0231] In some implementations, the guide frame and the tethers are cut from a unitary tube.

[0232] In some implementations, the tethers are chains.

[0233] In some implementations, the tethers are ribbons.

[0234] In some implementations, the tethers are interconnected struts.

[0235] There is further provided, in accordance with some implementations, a system for use with tissue of a heart, the system comprising: (a) an implant; and / or (b) a delivery assembly.

[0236] In some implementations, the delivery assembly includes: (i) a handle, and / or (ii) a guide assembly, having a distal part that is transluminally advanceable to the heart while in a delivery state. In some implementations, the guide assembly comprises a guide frame, intracardially: (a) expandable, using an expansion-control device on the handle, toward an expanded state via, and / or (b) advanceable distally towards the tissue, using an advancement-control device on the handle.

[0237] In some implementations, the guide assembly comprises a guide rail. In some such implementations, the guide assembly comprises multiple fasteners that are intracardially tightenable, from a handle of the delivery assembly, in a manner that draws the guide rail into a guide arrangement around at least part of the guide frame.

[0238] In some implementations, the delivery assembly comprises a driver, configured to advance the implant along the guide rail in the guide arrangement.

[0239] In some implementations, the system comprises a mechanism, e.g., on the handle, adapted to mate the expansion-control device with the advancement-control device such that operation of the expansion-control device concurrently operates the advancement-control device.

[0240] In accordance with some applications, a system and / or an apparatus (which can be used with a valve of a heart, e.g., of a living subject or of a simulation) includes an implant; and / or a delivery assembly. In some implementations, the delivery assembly includes: (i) a handle, (ii) a guide assembly, having a distal part that is transluminally advanceable to the heart while in a delivery state, and / or (iii) a driver.

[0241] In some implementations, the guide assembly includes: (I) a guide frame, intracardially expandable toward an expanded state, (II) a guide rail, (III) multiple fasteners, and / or (IV) a fastener-puller at the handle, adapted to intracardially tighten the fasteners, via a single operation of the fastener-puller, in a manner that draws the guide rail into a guide arrangement around at least part of the guide frame by the single operation simultaneously pulling the fasteners, , configured to advance the implant along the guide rail in the guide arrangement.

[0242] In accordance with some applications, a system and / or an apparatus (which can be used with a valve of a heart, e.g., of a living subject or of a simulation) includes a helical member; and / or a delivery assembly.

[0243] In some implementations, the helical member defines a head, and a helix extending away from the head.

[0244] In some implementations, the delivery assembly includes a guide assembly, having a distal part that is transluminally advanceable to the heart, the guide assembly comprising a guide rail.

[0245] In some implementations, the delivery assembly includes a driver, reversibly coupled to the helical member at the head, and configured to, while the guide rail is positioned along a surface of the tissue, anchor the helical member along the tissue by screwing the helical member over and along the guide rail and the tissue such that part of each turn of the helical member becomes embedded within the tissue, and another part of each turn lies above a surface of the tissue, wherein, the driver is coupled to the head in a manner in which withdrawing the guide rail out of the helical member and the head decouples the driver from the helical member.

[0246] In some implementations, the driver defines a driveshaft and a drivehead at a distal end of the driveshaft, the drivehead adapted to be reversibly coupled to the head. In some such implementations, the drivehead defines one or more arms that are biased to deflect medially upon retraction of the guide rail. In some such implementations, the guide rail is adapted to reversibly couple the drivehead to the head by extending through the drivehead such that the arms are deflected radially outwards, thereby maintaining the arms in engagement with an interior surface of the head.

[0247] In some implementations, the guide assembly further comprises a frame, the guide rail intracardially positionable around the frame in a manner that positions the guide rail along the tissue.

[0248] There is further provided, in accordance with some implementations, a system for use with a heart of a subject, the system comprising: a structure for use with the heart, and / or a delivery tool.

[0249] In some implementations, the delivery assembly includes a shaft having a distal end that is attached to the structure. In some implementations, the delivery assembly includes a constrictor adapted to compress the structure into a compressed state, the shaft extendingthrough the constrictor in a manner in which axially sliding the shaft with respect to the constrictor slides the structure into the constrictor.

[0250] In some implementations, the delivery assembly includes a catheter: (I) transluminally advanceable to the heart, and / or (II) defining a port into which a distally- facing nozzle of the constrictor is advanceable such that the structure, while in its compressed state, is advanceable to the heart, out of the constrictor, and through the port and the catheter.

[0251] In accordance with some applications, a system and / or an apparatus (which can be used with a valve of a heart, e.g., of a living subject or of a simulation) includes (i) a guide rail; (ii) a frame; (iii) a plurality of loops; (iv) a flexible helical member defining multiple turns; and / or (v) a driver.

[0252] In some implementations, the loops are adapted to adapted to intracardially position the guide rail into a guide arrangement circumferentially around a midsection of the frame. In some implementations, while the guide rail (a) is in the guide arrangement, and (b) lies along a surface of a tissue of the valve, the driver can anchor the helical member to the tissue, by screwing the helical member over and along the guide rail around the frame, such that part of each turn of the helical member becomes embedded within the tissue and another part of each turn lies above the surface of the tissue.

[0253] In some implementations: (I) the frame comprises a valve member secured to an interior of the frame, the valve member comprising multiple leaflets, (II) the upstream section and the downstream section are defined by an array of struts that define a cellular arrangement, and / or (II) the midsection is defined by struts that extend vertically between the upstream section and the downstream section, parallel with each other and with a longitudinal axis of the frame.

[0254] In some implementations, in an expanded state of the frame, a midsection of the frame has a smaller circumference than both an upstream section of the frame and a downstream section of the frame.

[0255] In accordance with some applications, a system and / or an apparatus (which can be used with a valve of a heart, e.g., of a living subject or of a simulation) includes (a) an implant and / or (b) a delivery assembly.

[0256] In some implementations, the implant includes: (i) a helical member; and / or (ii) a prosthetic heart valve.

[0257] In some implementations, the delivery assembly includes: a guide assembly, having a distal part that is transluminally advanceable to the heart while in a delivery state, the guide assembly comprising: (I) a guide frame, intracardially expandable toward an expanded state, (II) a guide rail, and / or (III) multiple fasteners that are intracardially tightenable, from a proximal extracorporeal portion of the delivery assembly, in a manner that draws the guide rail into a guide arrangement around at least part of the guide frame.

[0258] In some implementations, the delivery assembly includes a driver, configured to, while the guide rail is positioned along a surface of the tissue, anchor the helical member around the annulus by screwing the helical member over and along the guide rail and the tissue such that part of each turn of the helical member becomes embedded within the tissue, and another part of each turn lies above a surface of the tissue, the prosthetic heart valve being positionable within the native valve by positioning the prosthetic heart valve circumferentially within anchored helical member.

[0259] In accordance with some applications, a system and / or an apparatus (which can be used with a valve of a heart, e.g., of a living subject or of a simulation) includes (i) a guide rail; (ii) a frame; (iii) a plurality of loops adapted to intracardially position the guide rail into a guide arrangement circumferentially around the frame; (iv) a flexible helical member defining multiple turns; and / or (v) a driver. In some implementations, the driver is adapted to, while the guide rail (a) is in the guide arrangement and (b) lies along a surface of a tissue of the valve, anchor the helical member to the tissue, by screwing the helical member over and along the guide rail around the frame.

[0260] In some implementations, the system includes a handle. The frame can be (a) expandable, using an expansion-control device on the handle, toward an expanded state and / or (b) advanceable distally towards the tissue, using an advancement-control device on the handle. In some implementations, the handle comprises a mechanism on the handle adapted to mate the expansion-control device with the advancement-control device such that operation of the expansion-control device concurrently operates the advancement-control device.

[0261] In some implementations, the handle comprises a fastener-puller. The fastener-puller can be adapted to intracardially tighten the plurality of loops, via a single operation of the fastener-puller. In this manner, the fastener-puller can draw the guide rail into the guide arrangement around at least part of the frame by the single operation simultaneously pulling the plurality of loops.

[0262] In some implementations, the system further comprises (a) a shaft and (b) a constrictor. In some implementations, the constrictor is adapted to compress the frame into a compressed state. In some implementations, the shaft extends through the constrictor in a manner in which axially sliding the shaft with respect to the constrictor slides the frame into the constrictor.

[0263] In some implementations, the system further comprises a catheter that is transluminally advanceable to the heart. In some implementations, the catheter can define a port into which a distally-facing nozzle of the constrictor is advanceable such that the frame, while in its compressed state, is advanceable to the heart, out of the constrictor, and through the port and the catheter.

[0264] In some implementations, the plurality of loops are intracardially tightenable, from a proximal extracorporeal portion of a delivery assembly of the system. The plurality of loops can be tightened in a manner that draws the guide rail into a guide arrangement around at least part of the frame.

[0265] In some implementations, the driver is configured to, while the guide rail is positioned along a surface of the tissue, anchor the helical member around the annulus of the valve by screwing the helical member over and along the guide rail and the tissue. For instance, screwing the helical member over the guide rail can be performed such that part of each turn of the helical member becomes embedded within the tissue, and another part of each turn lies above a surface of the tissue.

[0266] In some implementations, the frame comprises a valve member secured to an interior of the frame. The valve member can comprise multiple leaflets.

[0267] In some implementations, the system further comprises (a) a control unit. In some implementations, the control unit can include a motorized drive, couplable to the driver at an extracorporeal portion of the apparatus, and adapted to drive the driver to drive the helical member into the tissue. In some implementations, the control unit can include a sensor, adapted to sense resistance encountered by the drive during the driving of the helical member into the tissue, and to provide a signal indicative of the resistance.

[0268] Any of the above method(s) and any methods of using the systems, assemblies, apparatuses, devices, etc. herein can be performed on a living subject (e.g., human or other animal) or on a simulation (e.g., a cadaver, cadaver heart, imaginary person, simulator, etc.). With a simulation, the body parts can optionally be referred to as “simulated” (e.g., simulatedheart, simulated tissue, etc.) and can optionally comprise computerized and / or physical representations.

[0269] Any of the above systems, assemblies, devices, apparatuses, components, etc. can be sterilized (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure they are safe for use with patients, and the methods herein can comprise (or additional methods comprise or consist of) sterilization of one or more systems, devices, apparatuses, components, etc. herein (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.).

[0270] The present disclosure will be more fully understood from the following detailed description of applications thereof, taken together with the drawings, in which:BRIEF DESCRIPTION OF THE DRAWINGS

[0271] Figs. 1, 2A-B, 3A-E, and 4A-V are schematic illustrations of an example system, and use thereof, in accordance with some implementations;

[0272] Figs. 5-8 are schematic representations of torque and / or resistance data in accordance with some implementations;

[0273] Fig. 9 is a schematic illustration of an example guide frame, in accordance with some implementations;

[0274] Figs. 10A-C, 11A-B, and 12 are schematic illustrations of example guide frames, in accordance with some implementations;

[0275] Figs. 13-14 are schematic illustrations showing techniques for verifying, through imaging, oscillating changes in the shape of a guide frame that are indicative of optimal placement of the guide frame, in accordance with some implementations;

[0276] Figs. 15A-B are schematic illustrations of an example fastener-puller, in accordance with some implementations;

[0277] Figs. 16A-B, and 17 are schematic illustrations of an example guide frame, in accordance with some implementations;

[0278] Figs. 18A-E are schematic illustrations of an example system, and use thereof, in accordance with some implementations;

[0279] Figs. 19-20 are schematic illustrations of various systems, in accordance with some implementations; and

[0280] Fig. 21 is a schematic illustration of an example system, and use thereof, in accordance with some implementations.DETAILED DESCRIPTION

[0281] The present disclosure includes different variants of some elements. Variants of a given element typically have the same structure and / or function as each other except for any differences described. For any given element for which different variants are disclosed, the identical name is used for each variant, in order to denote that they are, in fact, variants the same given element. Unless stated otherwise, applications of the devices, systems, and techniques described herein may include any arrangement in which one variant of an element is substituted with another identically-named variant of that element. Furthermore, throughout the figures, suffixes are used to denote different variants of the same element. Unless stated otherwise, such variants may be substituted with each other, mutatis mutandis. That is, unless stated otherwise, any element having a given reference numeral may be substituted with any other element (i.e., any other variant of the element) having the same reference numeral, independent of any suffix.

[0282] In order to avoid undue clutter from having too many reference numbers and lead lines on a particular drawing, some elements are introduced via one or more drawings and not explicitly identified in every other drawing that contains that element.

[0283] Reference is now made to Figs. 1, 2A-B, 3A-E, 4A-V, and 18A-E, which are schematic illustrations of an example of a system (e.g., apparatus) 20 and use thereof, in accordance with some implementations. In some implementations, system 20 comprises an implant 50, and / or a delivery assembly 100 for delivery and implantation of the implant.

[0284] In some implementations, system 20 can be used at an atrioventricular valve 7 of a heart 5 (e.g., of a subject, such as a living subject or a simulation, etc.), such as a tricuspid valve or a mitral valve.

[0285] In some implementations, implant 50 is adapted to change (e.g., reduce) a dimension of a tissue, e.g., to contract the tissue. For example, implant 50 can be an annuloplasty implant, configured to be implanted along an annulus 10 of valve 7, and to subsequently be contracted in order to contract the annulus and reduce regurgitation of the valve.

[0286] In some implementations, delivery assembly 100 comprises a guide assembly 200 adapted to guide the implantation of the implant. In some implementations, guide assembly200 comprises a guide rail 210 and a guide frame 220, as well as components for manipulation of the guide frame and guide rail, which are detailed hereinbelow.

[0287] In some implementations, delivery assembly 100 can also comprise a catheter 110 that comprises a sheath 112. In some implementations, catheter 110 can also comprise a handle 114 that facilitates transluminal advancement of sheath 112 to the heart. As detailed below, distal parts of guide assembly 200 (e.g., guide frame 220 and guide rail 210) may be advanced to the heart via catheter 110.

[0288] Fig. 1 shows components of system 20 separated out, e.g., as though system 20 were disassembled.

[0289] Fig. 2A shows at least some of these components put together. This can be considered an assembled state of guide assembly 200 with implant 50 stored therein. In some implementations, system 20 is provided with guide assembly 200 and implant 50 in this or a similar state. However, although guide rail 210 is shown as extending circumferentially around guide frame 220 (e.g., in the "guide arrangement" described hereinbelow), this arrangement of the guide rail may be attained only after the guide frame has been advanced into the heart, e.g., as described hereinbelow.

[0290] Fig. 2B shows an assembled state of delivery assembly 100 in which guide assembly 200 is extended through catheter 110, with guide frame 220 exposed out of the distal end of sheath 112 of the catheter. In this state, a handle 270 of guide assembly 200 may meet (e.g., may be engaged with) a handle 114 of catheter 110, e.g., as shown. It is to be noted that, in normal use, delivery assembly 100 becomes assembled into this assembled state only once sheath 112 has reached the heart, e.g., as described hereinbelow. Broadly speaking, it is in this state in which system 20 is used to implant implant 50, e.g., as described hereinbelow.

[0291] In some implementations, guide frame 220 can be defined by an array of wires or struts in an interwoven and / or cellular arrangement. In some implementations, guide frame 220 can define multiple openings or windows. This is shown in some close-up views, such as the insets of Fig. 3 A. For example, guide frame 220 can be formed by braiding filaments (e.g., wires) together or by cutting it out from a tube (e.g., similar to some stents). However, for the sake of simplicity and clarity, in most of the figures guide frame 220 is shown schematically as though it has a continuous surface, e.g., appearing like a balloon.

[0292] In some implementations, guide assembly 200 comprises a control shaft 250 and, at (e.g., fixed to) a proximal part of the control shaft, a handle 270. In some implementations,guide frame 220 is disposed (e.g., fixed to) a distal part 252 of control shaft 250. Thus, guide frame 220 is manipulable from handle 270 via control shaft 250.

[0293] In some implementations, implant 50 can comprise a helical member 60e.g., , such as a helical tissue anchor, which defines a helix (e.g., a coil) 62 that defines a central channel that the helix extends around and along. In some implementations, helical member 60 is adapted to be anchored (e.g., screwed) along a tissue (e.g., a valve annulus 10), and to be subsequently axially contracted (e.g., compressed), in order to contract (e.g., compress) the tissue. For example, this contraction can be used to draw the tissue radially inwards to circumferentially reduce the size of a valve annulus. Other implant configurations are possible.

[0294] In some implementations, implant 50 can comprise a tensile member 52 (e.g., a tether, wire, cord, ribbon) disposed through helical member 60 (e.g., within the central channel of helix 62) such that the axial contraction of helix 62 can be mediated at least in part by tensioning the tensile member. In some implementations, at a distal terminus of tensile member 52 can be a stop 54 (e.g., a cap, a bung, or a block) that is dimensioned not to fit through the central channel of helix 62.

[0295] In some implementations, helical member 60 has a sharpened tip 66 and is drivable through the tissue with tip 66 leading. In some implementations, helical member 60 can be sufficiently flexible to be transluminally advanced to the heart and to curve around a valve annulus 10. However, the helical member can also be sufficiently rigid that it can be screwed into the tissue, such as by applying torque to a proximal end (e.g., a head 64) of the helical member. For example, helical member 60 can exhibit deflectional flexibility (e.g., its central longitudinal axis can be easily deflected), but torsional stiffness (e.g., the helix may resist being untwisted upon being screwed into the tissue).

[0296] In some implementations, helix 62 is configured to have a constant pitch along its length, and / or is configured such that the pitch remains generally constant during anchoring to the tissue. Nonetheless, in some implementations, and as described hereinbelow, helical member 60 (e.g., helix 62 thereof) can be axially contracted (e.g., reducing its pitch) subsequent to its anchoring to the tissue, in order to contract the tissue.

[0297] In some implementations, delivery assembly 100 can further comprise a driver 300 for driving (e.g., screwing) helical member 60 along the tissue. In some implementations,driver 600 comprises a drivehead 304 that can be reversibly engaged with helical member 60 (e.g., to a head 64 thereof) in order to screw the helical member into the tissue.

[0298] In some implementations, driver 300 has a driveshaft 302 that extends along guide assembly 200, e.g., from a knob 306 at a proximal end of the driver to drivehead 304 at a distal end of the driver. In some implementations, driveshaft 302 transfers torque from knob 306 to helical member 60. In some implementations, driveshaft 302 is sufficiently flexible to extend transluminally to the heart. However, in some implementations, at a distal part of driveshaft 302, the driveshaft may have a high-flex region 308 that is more flexible than more proximal regions of the driveshaft. For example, high-flex region 308 may be cut to define vertebrae in a manner that provides greater flexibility than more proximal regions of the driveshaft.

[0299] In some implementations, torque is applied to driver 300 by manual rotation of knob 306, e.g., grasped between fingers of the operator. However, in some implementations, and as shown, torque is applied to driver 300 by a motorized drive 320. Drive 320 may be considered to be part of, or discrete from, delivery assembly 100.

[0300] In some implementations, and as shown, guide rail 210 may be a distal part of a tube (or other elongate component) 212 that extends proximally at least as far as handle 270. In some implementations, tube 212 is sufficiently flexible to extend transluminally to the heart. However, guide rail 210 may be a high-flex region of tube 212 that is more flexible than more proximal regions of the tube.

[0301] In some implementations, driveshaft 302 of driver 300 can be tubular. In the assembled state shown in Figs. 2A, (i) driveshaft 302 can be disposed coaxially over tube 212, with drivehead 304 engaged with head 64, (ii) coil 62 can extend distally from head 64 coaxially over tube 212, and (iii) control shaft 250 may be disposed coaxially over tube 212, drivehead 304, head 64, and coil 62. In the assembled state, coil 62 can be disposed proximally from guide rail 210 (e.g., proximally from the part of tube 212 that defines the guide rail).

[0302] In the assembled state, tensile member 52 can be disposed through tube 212. For example, and as shown, stop 54 may be disposed at a distal end of guide rail 210 (e.g., serving as a distal terminus or cap of the guide rail), and tensile member 52 may extend proximally from the stop, through the guide rail and the more proximal regions of tube 212.

[0303] In the assembled state, tensile member 52 can be fixed to tube 212 at a proximal part of guide assembly 200 in a manner that retains stop 54 at (e.g., in contact with) the distal end of guide rail 210, e.g., by locking-in tension to the tensile member. In some implementations, this fixation is provided by a clamp 216 at a proximal part (e.g., a proximal end) of tube 212, the clamp clamping onto tensile member 52 such that the tensile member secures stop 54 against the distal end of guide rail 210.

[0304] Figs. 3A-E illustrate the distal part of example guide assembly 200. Fig. 3A is a schematic illustration of guide frame 220 and components associated with it. One such component is / are one or more actuator wires 222 which can be actuated (e.g., tensioned) from the proximal part of guide assembly 200 (e.g., from handle 270) in order to intracardially expand the guide frame toward its expanded state. Figs. 2A-B and 3 A-C show an example of such an expanded shape of the guide frame, e.g., a mushroom shape.

[0305] Fig. 3B shows guide frame 220 without actuator wires 222 in order to more clearly show the other components associated with the guide frame. In some implementations guide assembly 200 may not include actuator wires (e.g., the guide frame may be self-expanding or may be expanded by other means) - and therefore Fig. 3B may alternatively be considered to represent a guide frame without actuator wires.

[0306] Fig. 3C shows guide frame 220 without any of the other components associated with it, in order to more clearly show actuator wires 222. In some implementations, three actuator wires extend and diverge distally through the interior of the guide frame in a tripod-like arrangement, and are coupled to the guide frame at respective connection sites 221 situated toward (e.g., at) the distal end of the guide frame.

[0307] In some implementations, guide frame 220 has an upstream section si, a downstream section s3, and a midsection s2 therebetween, e.g., these sections arranged along a longitudinal axis axl of the guide frame. In some implementations, and as shown, upstream section si is wider than midsection s2 (and optionally than downstream section s3) in order to provide a shoulder 224 for positioning against an annulus of the heart valve, as described hereinbelow.

[0308] Figs. 3D-E are perspective and cross-sectional views of the region in which guide frame 220 is coupled to distal part 252 of control shaft 250. This coupling may be provided by a ferrule 254 that sandwiches the proximal part of guide frame 220 (e.g., the proximal ends of the wires or struts of the guide frame) against the control shaft. In the example shown,the proximal ends of the wires or struts of guide frame 220 are distributed circumferentially around the outside of the control shaft and the inside of ferrule 254.

[0309] In some implementations, actuator wires 222 extend along control shaft 250, from the proximal part of guide assembly 200 to guide frame 220. In some implementations, the actuator wires may extend along the outside of control shaft 250, e.g., each actuator wire in a respective actuator-wire channel 256. In some implementations, and as shown, each actuator wire 222 is provided with two lengths running parallel with each other, with a bight of the actuator wire serving as the distal end of the actuator wire, looping around a wire or strut of guide frame 220 so as to attach the actuator wire to the guide frame at the respective connection site 221.

[0310] In some implementations, guide assembly 200 can further comprise one or more or multiple fasteners 214. In some implementations, the one or more or multiple fasteners can be configured to secure guide rail 210 in a guide arrangement in which the guide rail extends around at least part of guide frame 220.

[0311] In some implementations, fasteners 214 are intracardially tightenable in a manner that draws guide rail 210 into the guide arrangement, e.g., as described in more detail hereinbelow. In some implementations, in the guide arrangement guide rail 210 extends at least partway along / around the circumference of midsection s2 of guide frame 220 (e.g., describing an arc around the circumference). Figs. 2A-B and 3A-B show guide rail 210 in this guide arrangement. Thus, fasteners 214 can be distributed at least partway around midsection s2.

[0312] In some implementations, each fastener 214 is a fastener cord whose bight extends out of guide frame 220 to loop around guide rail 210. In such implementations, fasteners 214 can extend along control shaft 250, from the proximal part of guide assembly 200 to the interior of guide frame 220, e.g., alongside actuator wires 222. In some implementations, the fastener cords can extend along the outside of control shaft 250, e.g., each fastener cord in a respective fastener-cord channel 258. In some implementations, and as shown, each fastener cord is provided with two lengths running parallel with each other, with a bight of the fastener cord serving as the distal end of the fastener cord / fastener, looping around guide rail 210 so as to secure guide rail to the guide frame.

[0313] In some implementations, fastener-cord channels 258 are substantially longitudinally incompressible, and thereby provide a reference force that cooperates with the tension onfastener cords 214. Despite this, fastener-cord channels 258 can be flexible (e.g., laterally), e.g., sufficiently flexible to allow expansion and contraction of guide frame 220.

[0314] In some implementations, the actuator wires and the fastener cords (e.g., the actuatorwire channels and the fastener-cord channels) can be collectively arranged in an arc partially around control shaft 250, parallel and alongside each other, e.g., as shown. In some implementations, they are arranged with multiple fastener cords (e.g., fastener-cord channels) separating the actuator wires (e.g., the actuator-wire channels). In the particular example shown, where guide assembly 200 has three actuator wires (e.g., three actuator-wire channels) and eight fastener cords (e.g., eight fastener-cord channels), a 1-4-1-4-1 arrangement may be used. This is most clearly seen in Fig. 3E.

[0315] In some implementations, and as shown, each length (or optionally just one of the lengths) of each fastener cord is disposed within a respective sleeve 215 disposed through fastener-cord channel 258. In some such implementations, a pair of sleeves 215 (e.g., channels or tubes) extend through fastener-cord channel 258. In some implementations, fastener-cord channel 258 is defined by the pair of sleeves 215, i.e., no independent channel 258 (e.g., tube) is used to cover the pair of sleeves. In some such implementations, sleeves 215 may be held together using a ferrule or by being attached to each other. In some implementations, sleeves 215 may advantageously stabilize the arrangement of fastener 214, e.g., with the distal end of fastener-cord channel 258 disposed in the interior of guide frame 220 and facing / abutting a wire / strut of the guide frame, the sleeves extending out of the fastener-cord channel and either side of the wire / strut toward guide rail 210, and the bight of fastener cord 214 extending out of the sleeves to loop around the guide rail, e.g., see insets of Fig. 3 A. Advantageously, sleeves 215 can alternatively or additionally facilitate sliding of the lengths of the fastener cord within fastener-cord channel and / or in opposite directions past each other during the eventual loosening / release of guide rail 210 from guide frame 220 at later stages of use, e.g., by preventing tangling and / or friction between the two parallel lengths of fastener cord that are disposed within the channel.

[0316] In some implementations, actuator wires 222 and fastener cords 214 both extend distally between wires / struts of guide frame 220 and into the interior of the guide frame. In some implementations, fastener cords 214 do so within fastener-cord channels 258, e.g., the fastener-cord channels 258 (and sleeves 215 therewithin) extend into the interior of the guide frame. In contrast, actuator wires 222 may do so exposed from actuator-wire channels 256,e.g., the actuator-wire channels may terminate proximally from the guide frame and / or from ferrule 254. This can be seen in Fig. 3D.

[0317] In some implementations, it can comprise a coat 251 (e.g., comprising a polymer), a coat control shaft 250, actuator-wire channels 256, and / or fastener-cord channels 258. In some implementations, this provides a smooth outer surface.

[0318] In some implementations, during implantation, helical member 60 is advanced distally through control shaft 250 and over guide rail 210. In some implementations, guide assembly 200 is transluminally advanced to the heart with implant 50 and driver 300 already inside control shaft 250, e.g., as shown in Fig. 3E, in which coil 62 can be seen coaxially inside the control shaft, and guide rail 210 can be seen coaxially inside the coil. (However, in some implementations, implant 50 may be situated further proximally during transluminal advancement.)

[0319] In some implementations, during implantation, tensile member 52 may be disposed through tube 212. For example, and as shown, stop 54 may be disposed at a distal end of guide rail 210 (e.g., serving as a distal terminus or cap of the guide rail), and tensile member 52 may extend proximally from the stop, through the guide rail and the more proximal regions of tube 212. In some implementations, during implantation, tensile member 52 may be fixed to tube 212 at a proximal part of guide assembly 200 in a manner that retains stop 54 at (e.g., in contact with) the distal end of guide rail 210, e.g., by locking-in tension to the tensile member. In the example shown, this fixation is provided by clamp 216.

[0320] In some implementations, in order for guide rail 210 to attain the guide arrangement in which it extends around midsection s2, the guide rail extends through the interior of upstream section pl and exits guide frame 220 at the midsection, e.g., just below shoulder 224. Control shaft 250 (e.g., distal part 252 thereof) may extend distally beyond the location at which it is coupled to the guide frame (e.g., beyond ferrule 254) and at least as far as the interior of upstream section pl.

[0321] In some implementations, and as shown, a flexible tube or sleeve 253 serves as an extension of the lumen of control shaft 250, and extends out guide frame 220 at the midsection, e.g., just below shoulder 224 - such that helical member 60 remains ensheathed until it emerges outside of the guide frame (e.g., in the step described with reference to Fig. 4M).

[0322] Figs. 4A-V show at least some steps in the use of system 20 to treat a valve of a heart. Although the valve shown is a tricuspid valve, the system and techniques can be used similarly at another valve of the heart, such as the mitral valve.

[0323] In some implementations, helical member 60 is adapted to be anchored into the tissue via rotation (e.g., screwed into the tissue). In some implementations, a screw axis of helical member 60 can be disposed substantially parallel with the surface of the tissue (e.g., the valve annulus) such that each turn of the helix is disposed partly within the tissue and partly outside of the tissue. In some implementations, guide rail 210 is adapted to position and guide such screwing in of helical member 60 thereof by assuming, at least in part, a shape that will serve as a track along which the implant progresses. As described in more detail hereinbelow, guide frame 220 can facilitate such shaping and positioning of guide rail 210. As shown, guide rail 210 can arc around at least part of annulus 10, and helical member 60 can thereby be anchored in an arc around at least part of the annulus.

[0324] In some implementations, guide rail 210 is resistant to medial compression, thereby retaining its thickness during implantation. In some implementations, guide rail 210 is a hypotube having sufficient flexibility (e.g., by defining slits therealong) to arc around annulus 10.

[0325] In some implementations, guide frame 220 is self-expanding, e.g., its expansion can be achieved merely by unconstraining the guide frame. In some implementations, guide frame 220 is expanded by applying an expanding force, such as with a mechanical actuator or a balloon. In the example shown in Figs. 2A-4V, the expanding force is applied by tensioning actuation wires 222.

[0326] In some implementations, the guide frame 220 comprises (e.g., is formed from) a braided wire (or other filament). In some implementations, guide frame 220 is formed by cutting a stock material (e.g., is cut from a tube) to form a cellular trellis-like arrangement of struts.

[0327] In some implementations, the wire or struts of guide frame 220 can be formed from a metal (e.g., nitinol, stainless steel, and / or cobalt chrome) or from a polymer.

[0328] In some implementations, while expanded and at the native valve, guide frame 220 pushes the leaflets of the valve away from each other, and may result in the guide frame pressing against the tissue of the annulus. Nonetheless, the valve may continue to function at least in part, e.g., because guide frame 220 is open and allows blood flow therethrough,and / or because leaflets AL and PL remain partially functional (e.g., downstream of the guide frame), providing a net one-way flow of blood through the valve that may be sufficient for the duration of the procedure.

[0329] In some implementations, guide assembly 200 comprises one or more valve members, such as prosthetic leaflets, situated inside guide frame 220, to provide temporary valve functionality during the procedure, e.g., to compensate for disruption of native leaflet function. This is described in more detail with reference to Fig. 9.

[0330] In some implementations, upstream section si is adapted to be positioned in an atrium 6 upstream of the valve, and downstream section s3 is adapted to be positioned in a ventricle 8 downstream of the valve. Guide frame 220 can be shaped to facilitate placement of midsection s2 at an annulus 10 of an atrioventricular valve between the atrium and the ventricle, e.g., at / against an upstream surface of the annulus. For example, and as shown, while guide frame 220 is in its expanded state, downstream section s3 can taper away from midsection s2, such that the downstream section can be advanced, from the atrium, in a downstream direction through the atrioventricular valve until the midsection comes to rest against the upstream surface of the annulus of the valve. In some implementations, midsection s2 can lie generally orthogonal to a central longitudinal axis axl of guide frame 220 that extends from the upstream section to the downstream section (Fig. 3 A).

[0331] In some implementations, and as shown in Figs. 3A-C, upstream section si is wider than downstream section s3. This may advantageously allow for upstream section si to act as a flange for guide frame 220 when the guide frame is positioned at the valve. For instance, in this configuration, the upstream section can abut against an upstream surface of the annulus of the valve, thereby preventing downstream movement of the guide frame. As shown, once expanded, guide frame 220 assumes a mushroom-shaped form, with upstream section si shaped as the 'cap' of the mushroom, and defining a shoulder 224 that extends radially outwards (e.g., over a midsection of the guide frame).

[0332] In some implementations, guide rail 210 can extend along the tissue (e.g., of annulus 10) in a manner that complements (e.g., generally matches) the shape of the tissue. In some implementations, this can be facilitated by guide frame 220 being sufficiently compliant that its expanded shape is influenced by the existing shape of the tissue.

[0333] In some implementations, tensile member e.g., 52 extends through a central channel of helical member 60 following implantation.

[0334] In some implementations, during delivery, tensile member 52 can be disposed through guide rail 210 (such as through a lumen defined by the guide rail, as shown), or alongside the guide rail.

[0335] In some implementations, after the guide rail and the guide frame are withdrawn, tensile member 52 remains behind as a component of implant 50. In some implementations, the tensile member can be introduced after helical member 60 has been delivered and / or anchored. In some implementations, no distinct tensile member is used, e.g., helical member 60 itself adjusts the tissue.

[0336] In some implementations, guide assembly 200 comprises a plurality of spacers 230 that maintain spacing (e.g., radial spacing) between guide rail 210 and guide frame 220 at midsection s2, even while fasteners 214 pull the guide rail toward the guide frame. This spacing may advantageously facilitate anchoring of helical member 60 by allowing sharpened tip 167 to pass between the guide rail and the guide frame as the helical member is rotated. For example, this spacing may reduce a likelihood of helical member 60 catching or threading onto guide frame 220, and / or fastening the guide frame to the tissue.

[0337] In some implementations, each spacer 230 extends longitudinally alongside part of upstream section si, midsection s2, and part of downstream section s3. In some such implementations, at downstream section s3, the spacer enters guide frame 220 and extends across an interior of the guide frame to an opposite side of the guide frame, to which it is attached - e.g. such that the spacers overlap to form a spiral arrangement, as shown in Figs. 3 A-B. This arrangement may advantageously allow both ends of the spacer to be fixed (e.g., tied) to guide frame 220 without the spacer interfering with the expansi on / foreshortening / widening and compression / elongation / narrowing of the guide frame required for its use.

[0338] In some implementations, each of spacers 230 is a hollow tube 233 that defines a lumen therethrough. In some such implementations, for each spacer, a respective tether 231 (e.g., fastener, string, wire and / or connector) extends, from upstream section si where it is attached to the guide frame, through the respective lumen, and out of the lumen where it is attached to downstream section s3.

[0339] In implementations in which guide frame 220 defines multiple struts, each spacer can be attached to upstream section si and downstream section s3 by the respective tether 231 of the spacer being tied to respective struts of the guide frame.

[0340] Figs. 4A-V represent at least some steps in a procedure by which system 20 can be used to treat a valve 7 of a heart 5 of a subject, in accordance with some implementations. These figures are additionally intended to illustrate components and functionality capability of system 20, independently of any particular sequence of steps.

[0341] In some implementations, sheath 112 of catheter 110 is transluminally advanced towards (e.g., into) heart 5 (Fig. 4A). As described previously, this may be facilitated by handle 114 of the catheter, e.g., by advancing, rotating, and / or deflecting (actively steering) the distal end of sheath 112. Sheath 112 can be delivered through the vasculature of the subject until a distal end of the sheath extends within an atrium (e.g., a right atrium) of the heart. Sheath 112 may be positioned such that its distal opening faces valve 7.

[0342] In some implementations, catheter 110 is advanced with guide assembly 200 coupled thereto, e.g., with guide frame 220 disposed within sheath 112 (e.g., within a distal part of the sheath). For example, system 20 may be provided in such a state.

[0343] In some implementations, such as that shown, guide assembly 200 is introduced into catheter 110 after the catheter has been introduced into the subject. Figs. 4B-F show at least some steps of an implementation of such introduction, resulting in the distal part of guide assembly 200 (including guide frame 220) being situated within sheath 112 (Fig. 4F). However, the scope of the present disclosure includes other approaches to such introduction.

[0344] In some implementations, guide frame 220 is compressed (e.g., crimped) soon before its introduction into catheter 110, e.g., at the medical facility at which the implantation of implant 50 is to be performed. Figs. 4B-C show an example of how such compression may be achieved. Control shaft 250 is disposed through a constrictor 30 (Fig. 4B). In some implementations, guide assembly 200 is provided with constrictor 30 already mounted on control shaft 250 in this manner. In some implementations, constrictor 30 is mounted just prior to use (e.g., within the medical facility).

[0345] In some implementations, constrictor 30 is moved distally along control shaft 250 so that a distal mouth 32 (e.g., nozzle) of the constrictor engulfs guide frame 220 (e.g., the guide frame is pulled into mouth 32), compressing the guide frame into the narrow interior of the constrictor (Fig. 4C). In this state, and as shown in Fig. 4D, guide assembly 200 and constrictor 30 are moved together distally in order to introduce mouth 32 into a port 116 of catheter 110 (e.g., defined in handle 114). As shown, mouth 32 may be shaped to facilitatethis, e.g., may be defined by, or shaped as, a spout 34 that protrudes from the main body of constrictor 30.

[0346] In some implementations, while constrictor 30 remains in place, guide assembly 200 is advanced distally, such that control shaft 250 slides distally through the constrictor and the distal part of the guide assembly (e.g., the crimped guide frame 220) is pushed out of mouth 32 / spout 34, and into catheter 110 (Fig. 4E). Subsequently, constrictor 30 may be removed, e.g., control shaft 250 may be released from the constrictor (Fig. 4F).

[0347] In some implementations, constrictor 30 is formed from two parts 30a and 30b, which are separable to remove the constrictor from control shaft 250. (The initial mounting of constrictor 30 on control shaft 250 may similarly be achieved by connecting the two parts around the control shaft.) However, the scope of the present disclosure includes other approaches such as, but not limited to, parts 30a and 30b being hingedly coupled to each other. In some implementations, constrictor 30 remains coupled to guide assembly 200 (e.g., mounted on shaft 250) throughout the rest of the procedure.

[0348] In some implementations, port 116 includes a hemostatic valve. In some such implementations, the introduction of spout 34 pushes open the hemostatic valve such that, advantageously, the distal part of guide assembly 200 (e.g., guide frame 220 and / or guide rail 210) does not encounter the hemostatic valve when it is pushed into catheter 110, e.g., it is not required to push open the hemostatic valve.

[0349] In some implementations, control shaft 250 is sufficiently flexible to extend transluminally to the heart. However, distal part 252 of the control shaft may be, or may include, a high-flex region that is more flexible than more proximal regions of the control shaft. For example, and as shown in the enlarged view of Fig. 1, distal part 252 may be cut into vertebrae in a manner that provides increased flexibility. In some implementations, it may be advantageous to sacrifice strength of distal part 252 in order to achieve increased flexibility. In some such implementations, constrictor 30 is shaped to support (e.g., maintain straightness of) this high-flex region as control shaft 250 is pushed into catheter 110, e.g., to prevent buckling of the high-flex region. For example, constrictor 30 may be sufficiently long to contain both guide frame 220 and the high-flex region prior to advancement of the control shaft into the catheter. This containment may be snug in order to (i) radially constrict guide frame 220, and (ii) support the high-flex region.

[0350] It is to be noted that the distal part of guide assembly 200 appears different in Fig. 4B compared with preceding figures (e.g., Figs. 2A-B and 3A). In particular, in Fig. 4B guide frame 220 is shown lacking a distinct shape, and guide rail 210 is shown lying axially and / or helically along the guide frame rather than in its guide arrangement circumferentially around the guide frame. This represents that, during advancement through catheter 110, guide assembly 200 is in a low-profile delivery state. For example, actuator wires 222 may be slack, guide frame 220 may be flaccid, and / or guide rail 210 may be loose around the guide frame. In some implementations, this may be considered to be a relaxed state of guide assembly 200, and Fig. 4B may schematically illustrate this relaxed state. When drawn into constrictor 30, these components may become compressed together into an arrangement (e.g., a delivery state) suitable for advancement through sheath 112.

[0351] It is to be noted that the scope of the present disclosure includes frames other than the specific guide frame shown in this application. For example, such a constrictor mounted on a shaft could be used with any structure for use at a heart, e.g., with a prosthetic valve. Such a structure could be mounted on a distal end of the shaft, as explained with reference to the guide frame, and axially slid into the constrictor, compressed within the constrictor. Optionally, a distally-facing nozzle of the constrictor could fit directly into a port of a catheter (e.g., as shown), and the compressed structure could then be advanced to the heart through the catheter. In some implementations, the constrictor could be a crimping device for a prosthetic valve.

[0352] In the delivery state, (i) driveshaft 302 may be disposed coaxially over tube 212, with drivehead 304 engaged with head 64, (ii) coil 62 may extend distally from head 64 coaxially over tube 212, and (iii) control shaft 250 may be disposed coaxially over tube 212, drivehead 304, head 64, and coil 62. In the delivery state, coil 62 may be disposed proximally from guide rail 210 (e.g., proximally from the part of tube 212 that defines the guide rail).

[0353] In the delivery state, tensile member 52 may be disposed through tube 212. For example, and as shown, stop 54 may be disposed at a distal end of guide rail 210 (e.g., serving as a distal terminus or cap of the guide rail), and tensile member 52 may extend proximally from the stop, through the guide rail and the more proximal regions of tube 212. In the delivery state, tensile member 52 may be fixed to tube 212 at a proximal part of guide assembly 200 in a manner that retains stop 54 at (e.g., in contact with) the distal end of guide rail 210, e.g., by locking-in tension to the tensile member. In the example shown, this fixation is provided by clamp 216.

[0354] In some implementations, advancement of guide assembly 200 may continue until handle 270 reaches catheter 110, e.g., handle 114 thereof (Fig. 4G). In some implementations, and as shown, handle 270 is placed into engagement with handle 114 such that operation of an advancement-control device 118 (e.g., a rotational control device such as a knob, or a linear control device such as a slider) can provide controlled (e.g., fine) axial movement of guide assembly 200 with respect to catheter 110.

[0355] In some implementations, as shown, this engagement is a threaded engagement between an external and / or fixed thread 272 of guide assembly 200 (e.g., of handle 270) and an internal and / or rotatable thread of advancement-control device 118 (in this case, an advancement-control knob), which is a component of, or is mounted on, handle 114. Also, in some implementations, this engagement is achieved by part of 270 (e.g., thread 272) entering port 116. However, it is to be understood that other suitable engagement arrangements may be used including, but not limited to, the advancement-control device and / or the rotatable thread being components of, or mounted on, handle 270, mutatis mutandis. Thus, guide frame 220 can be quickly advanced towards the heart within sheath 112 in a gross-advancement manner (e.g., by simply pushing control shaft 250 distally) but, once the guide frame is within the heart, further advancement is performed in a fine- advancement manner.

[0356] In some implementations, delivery assembly 100 is configured (e.g., the length of guide assembly 200 relative to the length of catheter 110 is) such that the extent of advancement of guide assembly 200 required for handle 270 to reach catheter 110, and / or to be placed into engagement with handle 114, is sufficient to at least partially expose guide frame 220 from the distal end of sheath 112. In the implementation shown in Fig. 4G, guide frame 220 has become entirely exposed from sheath 112 by the time that thread 272 is engaged with advancement-control knob 118.

[0357] In the stage shown in Fig. 4G, guide assembly 200 remains in its relaxed state. In order to facilitate implantation of implant 50, guide assembly 200 is transitioned into its guide state, with guide frame 220 expanded, and guide rail 210 in its guide arrangement circumferentially around the guide frame (Figs. 4H-I). The figures show this being achieved by expanding guide frame 220 (Fig. 4H) and subsequently drawing guide rail 210 into the guide arrangement (Fig. 41). However, it is to be understood that these two processes may be performed in a different order to that shown, and / or may be performed in stepwise iterations of partial expansion of the guide frame and partial drawing of the guide rail.Nonetheless, for the sake of simplicity, Fig. 4H shows only expansion of guide frame 220, and Fig. 41 shows only drawing of guide rail 210 into the guide arrangement.

[0358] Fig. 4H shows expansion of guide frame 220. As described hereinabove, expansion of guide frame 220 is mediated by pulling on (e.g., tensioning of) actuator wires 222. This tensioning can cause the actuation wires to pull connection sites 221 proximally, thereby foreshortening guide frame 220. Guide frame 220 is configured (e.g., heat-set) with a predefined shape toward which it transitions upon such tensioning and foreshortening. In the example shown, this pre-defined shape is a mushroom shape, as noted hereinabove.

[0359] The actuation / expansion of guide frame 220 may, mutatis mutandis, share features with and / or utilize components described in International Patent Application PCT / IB2024 / 051018 to Avrahamov et al., filed 5 February 2024, and titled "Guidance of a tissue-adjustment coil", which is incorporated herein by reference.

[0360] In some implementations, the tensioning of actuator wires 222 is achieved via operation of an expansion-control device 276 (e.g., a rotational control device such as a knob (as shown), or a linear control device such as a slider) of handle 270. For example, and as shown, operation of expansion-control device 276 may axially move an actuation block 274 to which actuator wires 222 are fixed (e.g., via one or more clamps 279). In some implementations, this functionality is provided by a threaded mechanism / linear actuator, e.g., an external and / or fixed thread 277 of actuation block 274 engaged with an internal and / or rotatable thread of expansion-control device 276 (in this case, an expansion-control knob). However, it is to be understood that other suitable arrangements may be used including, but not limited to, the expansion-control device and / or the rotatable thread being components of, or mounted on, actuation block 274, mutatis mutandis.

[0361] Fig. 41 shows drawing of guide rail 210 into the guide arrangement. As described hereinabove, drawing of guide rail 210 into the guide arrangement is mediated by pulling on (e.g., tensioning of) fasteners 214. Each fastener may be a fastener cord that has two lengths running parallel with each other, with a bight of the fastener cord looping out of guide frame 220 and around guide rail 210 to serve as the distal end of the fastener cord / fastener, and the ends of the fastener cord being disposed at the proximal / extracorporeal portion of guide assembly 200, e.g., at handle 270.

[0362] In some implementations, pulling on the ends of the fastener cord draws the bight, and the portion of guide rail 210 around which the bight is looped, toward guide frame 220- and specifically toward the site 213 on the guide frame at which the fastener cord passes (e.g., exits) through the guide frame. (Exit sites 213 are visible and labeled in Figs. 4G-H.) In some implementations, sites 213 are distributed at least partway around the midsection of the guide frame (e.g., just below shoulder 224), such that pulling of the fastener cords draws the guide rail into being arranged at least partway around the midsection of the guide frame (e.g., just below shoulder 224).

[0363] Similarly to the insets of Fig. 3 A, the cross-sectional inset of Fig. 4N shows (i) the distal end of a fastener-cord channel 258 disposed in the interior of guide frame 220 and facing / abutting a wire / strut of the guide frame, (ii) sleeves 215 extending out of the fastenercord channel and either side of the wire / strut toward guide rail 210, and (iii) the bight of fastener cord 214 extending out of the sleeves to loop around the guide rail, thereby securing the guide rail in the guide arrangement at midsection s2.

[0364] In some implementations, handle 270 includes one or more clamps 278 or other locking devices that are operable to reversibly lock tension in fastener cords 214, e.g., by reversibly locking the fastener cords to the handle. In the example shown, each fastener cord 214 is individually tensionable and has a dedicated clamp 278. However, in some implementations, handle 270 includes a mechanism to pull on and / or reversibly lock tension in multiple fastener cords 214 at once. An example of such a mechanism is described with reference to Figs. 17A-B.

[0365] The drawing of guide rail 210 into the guide arrangement around guide frame 220 may, mutatis mutandis, share features with and / or utilize components described in International Patent Application PCT / IB2024 / 051018 to Avrahamov et al., filed 5 February 2024, and titled "Guidance of a tissue-adjustment coil", which is incorporated herein by reference.

[0366] In some implementations, guide assembly 200 is delivered to the heart while a distal end of guide rail 210 is affixed to guide frame 220 via a fixation wire 246 (Fig. 4H). This may prevent fasteners 214 from slipping off the distal end of the guide rail, and / or hold the guide rail in a linear arrangement during delivery to the heart. In some such implementations, fixation wire 246 is connected to a connector 244 of the guide rail in a manner that fastens the connector to a connection location on the guide frame. In some implementations, this connector 244 is an eyelet 247 disposed on a distal end portion of the guide rail (e.g., on stop 54). In some such implementations, the fixation wire extends out of the guide frame and loops through the eyelet on stop 54, thereby affixing the guide rail to the guide frame.

[0367] In some implementations, the fasteners are arranged in series along the guide rail, with a distalmost fastener 214a of the series being connected to a distal portion of guide rail 210, e.g., such that pulling on this distalmost fastener pivots the guide rail upstream towards the midsection. In some such implementations, the distalmost fastener 214a extends through eyelet 247 (e.g., in addition to fixation wire 246). This may advantageously reduce the degree of rotation that guide rail (e.g., a distal portion thereof) can move during the delivery of the guide assembly to the heart, as the guide rail is tethered by both the fixation wire and the distalmost fastener, e.g., as shown. In such implementations, the fixation wire must have sufficient slack to accommodate the moving of the guide rail in this upstream direction towards midsection s2 (Fig. 41). In some implementations, this slack is introduced into the fixation wire once the guide assembly has been delivered to the heart. In other implementations, the fixation wire is delivered to the heart while the fixation wire is sufficiently slack to accommodate this movement.

[0368] In some implementations, fixation wire 246 is intracardially withdrawable from eyelet 247 (e.g., by releasing one end and pulling from the other) to decouple the guide rail and / or stop 54 from the guide frame, e.g., prior to withdrawing the guide assembly from the heart.

[0369] Figs. 4J-K shows guide assembly 200 being advanced progressively distally such that guide rail 210 becomes placed against tissue adjacent valve 7, e.g., against the annulus of the valve. This can be facilitated by shoulder 224 of guide frame 220 being pressed against atrial tissue (e.g., against the bottom of the atrium), thereby optimally positioning guide rail 210 (which lies around midsection s2) against the tissue along which helical member 60 is to be driven, e.g., along the annulus of valve 7. Fig. 4J shows guide assembly having been advanced such that guide rail 210 approaches the annulus, and Fig. 4K shows further advancement such that shoulder 224 presses against the bottom of the atrium and the guide rail is disposed against the annulus (hidden from view). An additional inset in Fig. 4K shows a top-down view in which guide rail 210 is visible through upstream section si of guide frame 220.

[0370] Such distal advancement of guide assembly 200 (as well as its proximal retraction later in the procedure) may be mediated by operation of advancement-control device 118, described hereinabove. In some implementations, and as shown, catheter 110 (e.g., sheath 112 thereof) remains substantially stationary during such advancement. However, in someimplementations, catheter 110 may be advanced or otherwise manipulated in order to facilitate optimal positioning of guide assembly 200.

[0371] Reference is now made to Figs. 18A-E, which illustrate a system 20a comprising a delivery assembly 100a, in accordance with some implementations. System 20a can be identical to system 20, unless noted otherwise.

[0372] In some implementations, and as illustrated in Figs. 18A-E, rather than positioning the guide rail against the annulus once the guide frame is fully expanded, the guide frame is expanded in two stages: the guide frame is first partially expanded within the heart (e.g., while the guide frame is suspended within the atrium upstream of the valve, as illustrated in the transition between Figs. 18A to 18B), and the guide rail is then drawn into its guide arrangement around the partially expanded guide frame (Fig. 18C). The partially expanded guide frame is then moved downstream within the heart (Fig. 18D), until the guide rail abuts the annular tissue, and the guide frame is then fully expanded (Fig. 18E). This may advantageously facilitate positioning of the guide rail against the annulus, i.e., without the expanded guide frame becoming prematurely wedged within the atrium upstream of the annulus, preventing the guide rail from contacting the annulus. In some such implementations, during the movement of the guide rail toward the guide arrangement, the guide frame remains clear of the tissue (i.e., the tissue does not obstruct movement of the guide rail with respect to the guide frame), the guide frame being placed against the annulus only subsequently. In some such implementations, during the second stage of expansion of guide frame 220 (e.g., once guide rail 210 is placed against the annulus), a distalward force is applied to the guide frame, thereby preventing the guide frame and guide rail 210 from moving with respect to the tissue - e.g., due to foreshortening of the guide frame associated with its expansion.

[0373] In some such implementations, delivery assembly 100a is operable to mate the expansion of the guide frame with applying such a distalward force. For example, handle 270 may comprise a mechanism (e.g., an interlock) 900 that an operator (e.g., physician) can actuate once the first stage of expansion is complete, to enforce this pushing-whileexpanding mode during the second stage of expansion. That is, once mechanism 900 has been actuated, the operator can perform the second stage of expansion via operation of expansion-control device 276 without being required to separately apply the distalward force - e.g., without being required to separately operate advancement-control device 118. For example, actuation of mechanism 900 may mate expansion-control device 276 withadvancement-control device 118 such that operation of the expansion-control device concurrently operates the advancement-control device (or vice versa) - e.g., with a calibrated ratio between them.

[0374] Referring back to Figs. 4A-V. In some implementations, while guide assembly 200 remains in place, coil 62 of helical member 60 is driven helically over and along guide rail 210 (Figs. 4M-N). The position of guide rail 210 is such that this advancement screws coil 62 into the surface of the tissue, thereby anchoring helical member 60 along the surface of the tissue (e.g., along the surface of the annulus) in an arc that at least partly corresponds to the curvature of guide rail 210. Each turn of coil 62 may be partly within the tissue and partly outside of the tissue, e.g., as shown in the cross-sectional inset of Fig. 4N.

[0375] In some implementations, the direction of screwing of the coil is such that the tip of the coil repeatedly enters the atrially-facing surface of the annulus at an upstream location, and turns medially (i.e., downstream towards the valve and the ventricle) within the tissue. This may advantageously prevent the helical member from accidentally catching onto the leaflets, thereby inadvertently pinning them to the ventricular wall.

[0376] This driving of helical member 60 may be performed by / using driver 300, with its drivehead 304 engaged with (e.g., locked to) head 64 of helical member 60. As noted hereinabove, driveshaft 302 transfers torque from knob 306 to helical member 60. In some implementations, the torque is applied to knob 306 manually, e.g., by the operator grasping the knob and rotating it. In some implementations, and as shown, the torque is applied to knob 306 by motorized drive 320. Drive 320 has a socket 322 for receiving knob 306. The motor of the drive rotates socket 322 and thereby knob 306.

[0377] Fig. 4L shows drive 320 being engaged with knob 306 prior to driving driver 300. In some implementations, and as shown, tube 212 extends further proximally than driver 300, e.g., it may protrude proximally out of driveshaft 302, beyond knob 306. In such implementations, a window 324 may be defined through socket 322, and optionally drive 320 as a whole, so that the socket can be introduced over and along the proximal end of tube 212 in order to reach knob 306, e.g., tube 212 is threaded through window 324. In implementations in which clamp 216 is included, window 324 can be dimensioned to allow the clamp to pass therethrough.

[0378] Fig. 4M shows helical member 60 having been driven partway along guide rail 210, and Fig. 4N shows it having been driven all the way to the end of the guide rail, reaching stop 54.

[0379] Once it has been determined that helical member 60 has been successfully driven / anchored along the annulus of valve 7, guide assembly 200 can be withdrawn, e.g., removed from the body of the subject. Figs. 4O-S illustrate at least some steps in that withdrawal.

[0380] The anchoring of helical member 60 to tissue couples guide assembly 200 to the tissue. In order to decouple guide assembly 200 from the tissue, guide rail 210 is retracted from within helical member 60. To facilitate this, fasteners 214 and tensile member 52 may first be at least partly released from guide rail 210, e.g., as described with reference to Figs. 4O-P.

[0381] Fig. 40 shows fasteners 214 being unlooped from guide rail 210, e.g., by releasing clamps 278 and pulling on one end of each fastener cord 214 such that the other end of the fastener cord is drawn distally at least until it becomes exposed at, and unloops from, the guide rail. However, in some implementations, unlooping is not required and merely introducing slack into the fastener cord (e.g., by releasing clamps 278) is sufficient to release guide rail 210. As noted hereinabove, sleeves 215 may advantageously facilitate this release by facilitating sliding of fastener cord 214.

[0382] Fig. 4P shows clamp 216 being released, thereby slackening tensile member 52 so that it ceases to secure stop 54 against the distal end of guide rail 210, thereby allowing tube 212 (including the guide rail) to be retracted proximally away from stop 54, and out from within helical member 60. Fig. 4P shows guide rail 210 having been retracted partway out from within helical member 60, and Fig. 4Q shows further retraction of the guide rail, such that its distal end is proximal from helical member 60.

[0383] In some implementations, system 20 is configured such that the retraction of guide rail automatically triggers or allows disengagement of drivehead 304 from head 64 of the helical member. For example, and as shown, drivehead 304 may have one or more arms 305 that are maintained in engagement with an interior surface of head 64 (e.g., are prevented from deflecting medially away from the interior surface and / or toward each other) by the presence of tube 212 / guide rail 210 through the drivehead (e.g., between the arms). That is, the guide rail, via extension therethrough, can deflect the arms radially outwards.

[0384] In some implementations, and as shown, arms 305 are biased to deflect medially (and thereby disengage from head 64) upon retraction of the guide rail.

[0385] In some implementations, arms 305 remain stationary upon retraction of the guide rail, but are able to transiently deflect medially in response to subsequent pulling of driver 300 away from helical member 60, e.g., upon retraction of the guide rail the drivehead 304 remains engaged with, but becomes disengageable from, head 64.

[0386] In some implementations, guide frame 220 can then be relaxed by slackening actuation wires 222, e.g., by operating expansion-control device 276 in reverse (Fig. 4R). Optionally, advancement-control device 118 may also be operated in reverse so as to draw guide frame 220 toward sheath 112 and / or to allow disengagement of handle 270 from catheter 110. In some implementations, actuator wires 222 may have sufficient column strength and / or rigidity that pushing them distally pushes the downstream section of the guide frame away from the upstream section of the guide frame, thereby elongating and narrowing the guide frame. Thus, in such applications, expansion-control device 276 may be operated in reverse such that it pushes actuator wires 222 to facilitate withdrawal of guide frame 220.

[0387] In some implementations, subsequently, guide frame 220 is retracted into sheath 112 (becoming compressed as it enters the sheath), and guide assembly 200 is withdrawn from the subject (Fig. 4S).

[0388] In some implementations, a tool or adjustment tool 400 can then be used to contract implant 50, and thereby adjust the dimensions of (e.g., contract) the tissue at which the implant is implanted, e.g., the annulus of valve 7. In some implementations, the distal part (i.e., the working end) 410 of tool 400 is advanced over and along tensile member 52, through sheath 112 to helical member 60, e.g., to head 64 thereof (Fig. 4T).

[0389] Although not shown in Fig. 1, it is to be understood that tool or adjustment tool 400 may, in some implementations, be a component of system 20.

[0390] In some implementations, while distal part 410 abuts helical member 60 (e.g., head 64 thereof), operation of a contraction-control device 422 (e.g., a rotational control device such as a knob, or a linear control device such as a slider) tensions tensile member 52 in a manner that axially contracts coil 62 and reduces a dimension of valve 7, thereby reducing regurgitation through the valve. Contraction-control device 422 may belong to an extracorporeal portion (e.g., handle) of tool 400, e.g., as shown.

[0391] In some implementations, once it has been determined that an optimal degree of contraction has been achieved, tool 400 is used to lock the tension in tensile member 52, and to trim the tensile member (Fig. 4V). This may be achieved, for example, via operation of a lock-and-cut-control device 424 (e.g., a rotational control device such as a knob, or a linear control device such as a slider), which may belong to an extracorporeal portion (e.g., handle) of tool 400, e.g., as shown.

[0392] In some implementations, a lock 56 (which may, in some implementations, be considered a stopper) may be disposed within distal part 410. In some implementations, lock- and-cut control device 424 actuates distal part 410 to lock lock 56 to tensile member 52, and / or to cut the tensile member proximally from the lock, allowing tool 400 (and catheter 110) to be removed from the subject, leaving the contracted implant 50 implanted in the subject.

[0393] Tool 400 may share some or all features with, and / or utilize some or all components of, any of the adjustment tools (e.g., tool 400 and variants thereof) described in International Patent Application PCT / IB2023 / 062298 to Halabi et al., filed 6 December 2023, and titled "Annuloplasty implants and systems for use therewith", which published as WO 2024 / 121770, and which is incorporated herein by reference.

[0394] Lock 56 may share some or all features with, and / or utilize some or all components of, any of the locks described in International Patent Application PCT / IB2023 / 062298 to Halabi et al., filed 6 December 2023, and titled "Annuloplasty implants and systems for use therewith", which published as WO 2024 / 121770, and which is incorporated herein by reference.

[0395] Tool 400 and / or lock 56 may share some or all features with, and / or utilize some or all components of, any of the adjustment / tensioning tools or locks described in any of the following publications, each of which is incorporated herein by reference:US 2019 / 0274674 to Sutherland et al.US 2020 / 0015971 to Brauon et al.US 2021 / 0145584 to Kasher et al.

[0396] Reference is now made to Fig. 21. In some implementations, the helical member can be used to support a prosthetic heart valve. For example, Fig. 21 illustrates an implant system that comprises an implant 50a and a prosthetic heart valve 700. Implant 50a may beconsidered to be a variant of implant 50. Implant 50a may be as described for implant 50, mutatis mutandis.

[0397] In some implementations, helical member 60 of implant 50a is implanted within the heart as described hereinabove, e.g., using delivery assembly 100 and / or guide assembly 200. Once the helical member has been implanted along / around the annulus, prosthetic valve 700 is delivered to the heart and expanded within the native valve.

[0398] In some implementations, implant 50a comprises tensile member 52, e.g., the helical member is implanted within the heart while the tensile member extends along the tissue, within a central channel defined by the helix. In some such implementations, the helical member is axially contracted (e.g., using tensile member 52), and the prosthetic heart valve is subsequently deployed. In other implementations, the helical member is not contracted prior to deployment of the prosthetic heart valve. For example, the helical member may be contracted subsequently to deployment of the prosthetic heart valve.

[0399] In some implementations, the helical member is not contracted at all. In some such implementations, implant 50a does not include a tensile member.

[0400] Fig. 21 shows a substantial gap between valve 700 and helical member 60. This may represent a final implantation state - e.g., in which modification of the native valve (e.g., annulus) by implant 50a makes it more suitable for implantation of valve 700.

[0401] In some implementations, implant 50a serves as a dock for valve 700. For example, once implantation of the implant system is complete, valve 700 may contact helical member 60, and / or may sandwich tissue against the helical member. Thus, for such implementations, Fig. 21 may be considered to represent an interim state in which valve 700 has been positioned and partly expanded within the native valve, but will be further expanded until the gap between valve 700 and helical member 60 has been reduced, or even eliminated.

[0402] Reference is now made to Figs. 5-8, 19, and 20 which are schematic representations of data and components associated with the use of a motorized drive, in accordance with some implementations. The use of motorized drive 320, described hereinabove, may aid the operator by reducing the need for manual rotation of driver 300. In some implementations, another advantage may be obtained by drive 320 including a force gauge / sensor 812 that measures, and outputs data indicative of, resistance to rotation (or torque) of socket 322.

[0403] As illustrated schematically in Fig. 19, drive 320 may be part of a subsystem 800 that comprises a control unit 810 that comprises a force gauge / sensor 812, in communicationwith drive 320. Sensor 812 can be used to sense / measure the resistance experienced by the drive during application of torque to the implant, and output a signal that is indicative of the measured resistance (e.g., the signal contains the data). The signal can be received by a DPS (Data-Processing System) 814 of control unit 810. The DPS 814 can be in electrical communication with sensor 812 (e.g., via a cable 816). The data may be outputted electronically, visually (e.g., via a display 818 of control unit 810), audibly, and / or haptically.

[0404] In some implementations, sensor 812 is provided as a component of drive 320 (e.g., within the same housing as a motor 326 of the drive). In some implementations, DPS 814 and display 818 may be provided (e.g., housed) together as a separate item (e.g., within a separate housing) that is connected to drive 320 and sensor 812 via cable 816 - e.g., such that the drive (and sensor) can be conveniently manually moved into engagement with knob 306 without the bulk and / or weight of DPS 814 and / or display 818.

[0405] In some implementations, the DPS provides a magnitude maximum for the contracting force, but not a minimum limit. In some implementations, the DPS provides a magnitude minimum for the contracting force, but not a magnitude maximum. In some implementations, the DPS both a minimum and maximum value for the contraction force.

[0406] In some implementations, data-processing system (DPS) 814 may monitor this data in real-time in order to verify that coil 62 is being driven normally or optimally through the tissue, and through the optimal tissue. Figs. 5-8 show a few examples of how this may be useful. In each of these figures, the x-axis may represent the duration over which drive 320 has driven helical member 60 (as labeled), or the number of turns that the helical member 60 has been rotated by the drive. In each of these figures, the dashed line represents the normal or expected increase in resistance (or torque) over the duration as progressively more turns of coil 62 are disposed within the tissue, and the solid line represents the measured resistance (or torque).

[0407] In some implementations, and as shown, the data-processing system is, or is a component of, a discrete (e.g., purpose-made) device. In some implementations, the data- processing system is a general -purpose data-processing system (e.g., a processor of a general-purpose computer) programmed to run the program.

[0408] Fig. 5 represents a situation in which a sudden increase in resistance (or torque) is measured. This may be indicative of some undesired event, such as tip 66 of coil 62becoming obstructed, e.g., by contact with a component of guide assembly 200. In such circumstances, drive 320 may be momentarily reversed, and optionally the position of coil 62 readjusted before recommencing driving helical member 60. In some implementations, such momentary reversal may be performed automatically in response to detection of such an obstruction.

[0409] Fig. 6 represents a situation in which resistance (or torque) progressively increases more rapidly than expected. This may be indicative of coil 62 being driven along tissue other than that which is intended, e.g., tissue of a leaflet rather than tissue of the annulus.

[0410] Fig. 7 represents a situation in which the measured increase in resistance (or torque) is as, or similar to, expected, but is lower in absolute value. This may be indicative of the tissue (e.g., the annulus of the valve) of the subject being weaker than expected (e.g., than average), e.g., due to being less fibrous and / or more fatty. In such circumstances, it may be advantageous to limit the tension subsequently placed on tensile member 52, and thereby the degree to which implant 50 is contracted, in order to avoid damaging the tissue. In some implementations, such a limit may be inputted into an adjustment tool 400a (which can be otherwise identical to adjustment tool 400), e.g., manually or by DPS 814.

[0411] In some implementations, an adjustment tool 400a comprises a selector 820 via which a user can select a degree of tension to be applied to the implant (e.g., a tension limit). Selector 820 can be a sliding element mounted on a track that defines a scale, such that either the user can determine the degree of tension by sliding the slider along the scale, or it can be inputted automatically by the control system. The degree of tension chosen by the user may be set responsively to the output provided by the DPS 814 - e.g., a tension limit may be set according to the tissue characteristics that were determined from the torque resistance.

[0412] In some implementations, DPS 814 can be programmed to provide an output that provides the user with a precise degree of contraction to apply - i.e., to a position along the scale.

[0413] In some implementations, the force applied to contract implant 50 can also be provided by a motorized drive. In some such implementations, drive 320 can be used for both functions - e.g., tool 400 (e.g., a variant thereof) may be for engagement of knob 422 (or a variant thereof) by the drive. That is, in some implementations, a drive can be used to both implant an implant (e.g., implant 50) into tissue of the heart, and to contract the tissue by applying a contracting force to the implant while the implant remains in the tissue. Insome implementations, during the implantation of the implant into the tissue, a sensor (e.g., sensor 812) can measure the resistance during the implantation, and output a signal to a DPS (e.g., DPS 814), that, responsively to the signal, provides an output indicative of a magnitude limit for the contracting force to be applied by the drive via the adjustment tool. This output can be automatically inputted into the motor by the DPS, such that during contraction of the implant, the motor automatically limits the contraction based on the output.

[0414] It is to be noted that subsystem 800, and optionally adjustment tool 400a, could be used with other implants, e.g., with an annuloplasty system in which multiple screw-like anchors are anchored into the tissue while threaded onto a tether. For example, during anchoring of these anchors via application of torque, the amount of resistance to the torque could be measured. In some such applications, the measured resistance could be used to determine whether the tissue is adequate or suitable for anchoring of the anchor thereto. In some applications, the amount of contraction applied to the tether could then be set responsively to the measured resistance.

[0415] Fig. 8 represents a situation in which the measured increase in resistance (or torque) is irregular. This may be indicative of coil 62 being driven along irregular tissue, such as atrial trabeculae. In such circumstances, coil 62 may be unscrewed from the tissue, and the guide assembly repositioned before retrying.

[0416] Reference is now made to Fig. 9, which is a schematic illustration of an example implementation of a guide frame 220a, in accordance with some implementations. Although guide frame 220 is positioned in valve 7 during use, any disruption of the valve (e.g., obstruction of the leaflets) that may be caused by its presence is typically tolerable by the subject, e.g., due to the native leaflets continuing to function at least in part, and / or due to the brevity of the procedure. Nonetheless, in some implementations it may be advantageous to include one or more valve members, such as a leaflet, a diaphragm, a ball, a tilting disc, or a duckbill, within the guide frame in order to provide temporary prosthetic valve functionality during the time that the guide frame is present within valve 7.

[0417] In some implementations, guide frame 220a is a guide frame that includes one or more valve members 226 for this purpose. In some implementations, valve members 226 are prosthetic leaflets.

[0418] In Fig. 9, the upper image shows valve members 226 open / separated as they would be during ventricular diastole, and the lower image shows the valve members closed / coapting as they would be during ventricular systole.

[0419] In some implementations, guide frame 220a may be considered to be a variant of guide frame 220, and may be used as described for guide frames elsewhere herein, mutatis mutandis. For example, any of the other guide frames described herein may be substituted with guide frame 220a, mutatis mutandis. Similarly, other guide frames described herein may be modified to include features or characteristics of guide frame 220a.

[0420] Reference is now made to Figs. 10A-C, 11A-B, and 12, which are schematic illustrations of guide frames 220b, 220c, and 220d, in accordance with some implementations. Rather than having a mushroom-shape, these guide frames are hourglass- or dumbbell-shaped, meaning that both section si and section s3 are wider than section s2. Guide frames 220b, 220c, and 220d may be considered to be variants of guide frame 220, and may be used as described for guide frames elsewhere herein, mutatis mutandis. For example, any of the other guide frames described herein may be substituted with guide frame 220b, guide frame 220c, or guide frame 220d, mutatis mutandis. Similarly, other guide frames described herein may be modified to include features or characteristics of guide frames 220b, 220c, or 220d.

[0421] Hourglass- or dumbbell-shaped guide frames may provide even greater control of the positioning of the guide assembly, e.g., because the tissue (e.g., the annulus of valve 7) can be bookended between expanded section 1 in the atrium and expanded section 3 in the ventricle.

[0422] In some implementations, guide frame 220b (Figs. 10A-C) is an example of such a guide frame whose section si is expanded before its section s3. This can advantageously allow section s3 to be advanced unexpanded into the ventricle, but only as far as required because the shoulder provided by expanded section si abuts the annulus to prevent overadvancement. For example, section si can be expanded (Fig. 10A), section s3 can then be advanced into the ventricle (Fig. 10B), and section s3 can then be expanded within the ventricle (Fig. 10C).

[0423] In the example shown, this functionality of guide frame 220b is achieved using two sets of actuator wires 222: a set of upstream actuator wires 222' configured to actuate / expand section si (e.g., by being coupled to the guide frame near the transition between section siand section s2), and a set of downstream actuator wires 222" configured to actuate / expand section s3 (e.g., by being coupled to the guide frame near the downstream end of the guide frame).

[0424] In some implementations, guide frame 220c (Figs. 11A-B) is another example of such a guide frame whose section si is expanded before its section s3. Section s3 can be advanced into the ventricle after section si has already been actuated / expanded (Fig. 11 A), and section s3 can then be expanded within the ventricle (Fig. 1 IB).

[0425] In some implementations, as shown, this functionality of guide frame 220c can be achieved using a restraint 228 that constrains section s3 until it is within the ventricle. In some implementations, restraint 228 may be a wrapping such as a cord (as shown) or a sheet, a clamp, a latch, or any other suitable component. This approach may be used for guide frames that have only one set of actuation wires, or those that are self-expanding such as guide frame 220e described hereinbelow, mutatis mutandis.

[0426] In some implementations, guide frame 20d is expanded the other way around: Section s3 is advanced into the ventricle, expanded, and then pulled upstream so that the shoulder provided by expanded section s3 abuts the underside of valve 7 (as shown in Fig. 12) prior to expansion of section si . This may be achieved using actuator wires, a constraint, or simply by restraining section si within sheath 112 until it is to be expanded.

[0427] In some implementations, a guide frame can be used that has an inverted mushroom shape - e.g., having a downstream section s3 that is wider than midsection s2 and upstream section si. In some such implementations, its downstream section s3 can be expanded within the ventricle, and can then be pulled proximally towards valve 7 until the ridge or cap defined by the expanded downstream section abuts the ventricularly-facing surface of the valve. Guide frame 220d (Fig. 12) can be understood to be showing this, e.g., alternatively to showing a step in a placement procedure of a dumbbell shaped guide frame, Fig. 12 can also be understood to show such an inverted shaped guide frame.

[0428] Reference is now made to Figs. 13 and 14, which are schematic illustrations showing techniques for verifying, through imaging, oscillating changes in the shape of guide frame 220 (or any variant thereof) that are indicative of optimal placement of the guide frame, in accordance with some implementations.

[0429] In some implementations, once it is believed that guide frame has been optimally placed, with the shoulder provided by section si disposed against the annulus of valve 7, thecontrol shaft may be advanced slightly further distally / downstream, or even reciprocatingly advanced and retracted - as indicated by the double-headed arrow (Fig. 13). Because the annulus of valve 7 inhibits the shoulder provided by section si from moving distally, section si becomes axially compressed when the control shaft pushes it distally / downstream, and may axially decompress when this pushing ceases or is reversed. If section si were not disposed against the annulus this effect would not occur. In contrast, if upstream section si is indeed wedged correctly against the annulus, the shape of section s3 within ventricle 8 should not be affected by this movement of the control shaft. The oscillating shape change of section si, and optionally the relatively unchanging shape of section s3, can be observed using an imaging technique such as fluoroscopy or echocardiography, and can therefore be used to verify that section si is disposed against the annulus.

[0430] Fig. 14 shows another oscillating shape change that may be used to determine optimal placement of the guide frame. Once section s3 is disposed within ventricle 8, the leaflets of valve 7 press against and compress section s3 (e.g., medially) during each ventricular systole, and section s3 may radially decompress during ventricular diastole. If section s3 were not disposed (e.g., in a symmetrical position) within the ventricle this effect would not occur. In contrast, the shape of section si within atrium 6 is not affected in this manner. In some implementations, the oscillating shape change of section s3, and optionally the relatively unchanging shape of section si, can be observed using an imaging technique such as fluoroscopy or echocardiography, and can therefore be used to verify that section s3 is disposed in the ventricle, and / or that section si is disposed in the atrium.

[0431] Reference is now made to Figs. 15A-B, which are schematic illustrations of a fastener-puller 280, in accordance with some implementations. As described hereinabove (e.g., with reference to Fig. 41), guide rail 210 may be drawn into the guide arrangement by pulling on (e.g., tensioning of) fastener cords 214. Fastener-puller 280 is mounted on handle 270, and advantageously facilitates pulling on multiple (e.g., all of) fastener cords 214 via a single operation of the fastener-puller.

[0432] In some implementations, and as shown, the length of each fastener cord 214, and / or the distance that it is required to be pulled (e.g., the length by which it is required to be shortened) may be different to that of other fastener cords. In some such implementations, fastener-puller 280 is configured such that operation thereof pulls each fastener cord 214 a different distance - the distance that is required for that particular fastener cord.

[0433] In some implementations, as shown, along guide rail 210 each fastener cord 214 is progressively longer than the last in order to accommodate, the axial or helical disposition of the guide rail during advancement through sheath 112 and / or prior to the guide rail being drawn into the guide arrangement, e.g., as illustrated in Figs. 4B, 4G-H, and 15 A. Therefore, in the implementation shown, fastener-puller 280 is configured to, upon being operated, pull each fastener cord 214 by a progressively longer distance. In some implementations, and as shown, this is achieved by fastener-puller 280 being fashioned as a lever that pivots about a fulcrum 281. In some implementations, each fastener cord 214 is progressively further from the fulcrum, and is therefore pulled by a progressively greater distance when the lever is operated (Fig. 15B).

[0434] Reference is now made to Figs. 16A-B, and 17 which are schematic illustrations of a guide frame 220e, in accordance with some implementations. As noted hereinabove, guide frame 220 may be formed by braided wires, or by cutting it out from a tube. Guide frame 220e is an example of a guide frame formed by cutting its cellular structure from a tube.

[0435] In some implementations, guide frame 220e may be considered to be a variant of guide frame 220, and may be used as described for guide frames elsewhere herein, mutatis mutandis. For example, any of the other guide frames described herein may be substituted with guide frame 220e, mutatis mutandis. Similarly, other guide frames described herein may be modified to include features or characteristics of guide frame 220e.

[0436] In some implementations, struts 234 of guide frame 220e situated at section s2 may be perforated to define holes through which fasteners 214 may exit the guide frame to loop around the guide rail.

[0437] In some implementations, struts 234 situated at section s2 can be vertical - e.g., parallel with a longitudinal axis of the guide frame and / or with each other. This may advantageously prevent helical member 60 from accidentally catching onto the guide frame during anchoring of the helical member therearound. Struts 234 situated at si and s3 can be oblique to the longitudinal axis of the guide frame, e.g., thereby defining a cellular arrangement, as shown.

[0438] In some implementations, in order to prevent helical member 60 from catching onto the guide frame, the struts of the frame at the midsection may be substantially parallel to a longitudinal axis of the guide frame, thereby advantageously decreasing the chances of the helical member catching onto the midsection. For example, rather than midsection s2 of theframe defining a cellular design, the struts may be vertical, and parallel with each other. As shown, a pair of struts (i.e., a strut-pair) may converge from upstream section si, extending axially alongside each other along the midsection to downstream section s3, where the pair diverges away from each other to form the cellular pattern that defines the downstream section. This may render the struts at midsection s2 thicker than the struts that define the upstream and / or downstream sections, advantageously decreasing the likelihood of the helical member catching onto the frame. For example, in some such implementations, these struts may be too thick to enter between the guide rail and a tip of helical member 60. In some implementations, each strut-pair at midsection s2 is covered with a covering or sleeve, e.g., to further increase the thickness of the strut-pairs.

[0439] In some implementations, the struts at one or more axial / latitudinal positions along guide frame 220e (e.g., at 232) may be modified for increased flexibility. When the guide frame is compressed in its delivery state, these axial / latitudinal positions may therefore serve as articulation points, e.g., such that the compressed guide frame has multiple relatively- rigid sections articulatably coupled to each other at these axial / latitudinal positions. This may advantageously facilitate advancement of the compressed guide frame, within sheath 112, along the tortuous transluminal pathway to valve 7.

[0440] Any of the guide frames described herein may include tethers that connect upstream section si of the guide frame to the control shaft. However, guide frame 220e advantageously achieves this with integral tethers 236, which are cut from the same unitary tube as the rest of the guide frame. In some implementations, tethers 236 are formed as chains. However, they may take other forms, such as ribbons, wires, or interconnected struts. This may provide greater flexibility to the frame during delivery (e.g., along the tortuous path to the valve), and / or may facilitate better positioning of the frame within the heart. For example, in some implementations, the tethers can curve, from the distal end of the control shaft, to upstream section si (Fig. 17). This may advantageously accommodate the upstream section within the limited height of the atrium.

[0441] Example Implementations (some non-limiting examples of the concepts herein are recited below):

[0442] Example 1. An apparatus for use with a cardiovascular system, the apparatus comprising: (i) an implant; (ii) a motorized driver for driving the implant into tissue of the cardiovascular system; (iii) an adjustment tool, adapted to contract the tissue by applying a contracting force to the implant while the implant remains in the tissue; and / or (iv) a controlunit, comprising: (a) a drive, couplable to the driver at an extracorporeal portion of the apparatus, and adapted to drive the driver to drive the implant into the tissue, (b) a sensor, adapted to sense resistance encountered by the drive during the driving of the implant into the tissue, and to provide a signal indicative of the resistance, and / or (c) a data-processing system adapted to receive the signal and, responsively to the signal, provide an output indicative of a magnitude limit for the contracting force to be applied by the adjustment tool.

[0443] Example 2. The apparatus according to example 1, wherein: (i) the apparatus further comprises a guide assembly that comprises a guide rail, (ii) the guide assembly is configured to position the guide rail along a surface of the tissue, in a guide arrangement, and / or the driver is configured to, while the guide rail in the guide arrangement is positioned along the surface of the tissue, anchor the implant along the tissue and the guide rail.

[0444] Example 3. The apparatus according to example 2, wherein the output is indicative of a tissue type of the tissue.

[0445] Example 4. The apparatus according to any one of examples 1-3, wherein: (i) the implant is a helical member, (ii) the driver is configured to advance the helical member into the tissue by applying torque to the helical member, and / or (iii) the sensor is adapted to output the signal responsively to an amount of torque applied to the driver by the drive.

[0446] Example 5. The apparatus according to example 2, wherein: (i) the implant comprises a helical member, (ii) the driver is configured to, while the guide rail in the guide arrangement is positioned along the surface of the tissue, anchor the implant along the tissue by screwing the helical member along the guide rail and the tissue such that part of each turn of the helical member becomes embedded within the tissue, and another part of each turn lies above a surface of the tissue, and / or (iii) the output is indicative of a path of the helical member along the tissue.

[0447] Example 6. The apparatus according to example 2, wherein the output is indicative of a position of the implant within the cardiovascular system.

[0448] Example 7. The apparatus according to any one of examples 1-6, wherein, responsively to receiving a signal from the sensor indicative of a significant change in resistance encountered by the driver, the control unit is adapted to provide an alert.

[0449] Example 8. The apparatus according to any one of examples 1-7, wherein, responsively to receiving a signal from the sensor indicative of a sharp increase of resistance encountered by the driver, the control unit is adapted to provide an alert.

[0450] Example 9. The apparatus according to any one of examples 1-8, wherein: (i) the control unit is adapted to control the drive, and / or (ii) responsively to receiving a signal from the sensor indicative of a significant change in resistance encountered by the driver, the control unit is adapted to automatically stop the drive.

[0451] Example 10. The apparatus according to example 9, wherein responsively to receiving a signal from the sensor indicative of a sharp increase of resistance encountered by the driver, the control unit is adapted to automatically stop the drive.

[0452] Example 11. The apparatus according to any one of examples 1-10, wherein the control unit is adapted to determine, responsively to the signal, a change in resistance encountered by the drive over time, and to responsively provide the output.

[0453] Example 12. The apparatus according to example 11, wherein the control unit is adapted to provide the output via a user interface.

[0454] Example 13. The apparatus according to example 12, wherein the control unit is adapted to provide a graph indicative of the change in resistance over time, via the user interface.

[0455] Example 14. The apparatus according to example 1, wherein: (i) the implant further comprises a tensile member, and / or (ii) the adjustment tool is adapted to contract the tissue along which the implant is anchored by applying tension to the tensile member such that the implant becomes contracted.

[0456] Example 15. The apparatus according to example 14, wherein: (i) the drive is adapted to apply the tension via the contracting tool, and / or (ii) the control unit is adapted to apply the tension responsively to the output.

[0457] Example 16. The apparatus according to example 14, wherein: (i) the apparatus further comprises a guide assembly that comprises a guide rail, (ii) the guide assembly is configured to position the guide rail along a surface of the tissue, in a guide arrangement,(iii) the driver is configured to, while the guide rail in the guide arrangement is positioned along the surface of the tissue, anchor the implant along the tissue and the guide rail, and / or(iv) in the guide arrangement, the tensile member extends through the guide rail.

[0458] Example 17. The apparatus according to example 14, wherein: (i) the implant comprises a helical member, (ii) the driver is configured to anchor the implant along the tissue by screwing the helical member along the tissue such that: (a) part of each turn of thehelical member becomes embedded within the tissue, and another part of each turn lies above a surface of the tissue, (b) the multiple turns circumscribe a central channel of the helical member, and / or (c) the tensile member extends through the central channel, and / or (iii) the tensile member is configured to, upon being tensioned, axially contract the helical member.

[0459] Example 18. The apparatus according to example 17, further comprising a stopper coupled to a distal end of the tensile member, such that tension applied to the tensile member longitudinally contracts the helical member by the stopper inhibiting sliding of the tensile member through the central channel.

[0460] Example 19. The apparatus according to example 17, wherein the contracting tool is configured to contract the tissue along which the helical member is anchored by axially contracting the helical member.

[0461] Example 20. An apparatus for use with a cardiovascular system, the apparatus comprising: (a) an implant, (b) a guide assembly, having a distal part that is transluminally advanceable to the cardiovascular system while in a delivery state, the guide assembly comprising a guide rail that is positionable along tissue of the cardiovascular system, (c) a driver for screwing the implant into the tissue by advancing the implant over and along the guide rail in a first direction, (d) a control unit, comprising: (i) a drive, couplable to the driver at an extracorporeal portion of the apparatus, and adapted to drive the driver, and / or (ii) a sensor, adapted to output a signal indicative of resistance encountered by the drive during advancement, by the driver, of the implant into the tissue.

[0462] Example 21. An apparatus for use with a cardiovascular system, the apparatus comprising: (i) an implant, (ii) a guide assembly, having a distal part that is transluminally advanceable to the heart while in a delivery state, the guide assembly comprising a guide rail that is positionable along tissue of the cardiovascular system, (iii) a driver for screwing the implant into the tissue by advancing the implant over and along the guide rail in a first direction, (iv) a control unit, comprising: (a) a drive, couplable to the driver at an extracorporeal portion of the apparatus, and adapted to drive the driver, (b) a sensor, adapted to output a signal indicative of resistance encountered by the drive during advancement, by the driver, of the implant into the tissue, (c) a data-processing system adapted to: (I) receive the signal, (II) operate the drive to reverse along the guide rail in a second direction that is opposite to the first direction, and / or (III) operate the drive to subsequently re-advance the implant over and along the guide rail in the first direction.

[0463] Example 22. A system for use with tissue of a heart, the system comprising: (a) an implant; and / or (b) a delivery assembly comprising: (i) a guide assembly, having a distal part that is transluminally advanceable to the heart while in a delivery state, the guide assembly comprising: (I) a guide frame, intracardially expandable toward an expanded state, (II) a guide rail, and / or (III) multiple fasteners that are intracardially tightenable, from a proximal extracorporeal portion of the delivery assembly, in a manner that draws the guide rail into a guide arrangement around at least part of the guide frame, and / or (ii) a driver, configured to advance the implant along the guide rail in the guide arrangement.

[0464] Example 23. The system according to example 22, wherein the delivery assembly further comprises a fixation wire that is connected to a connector of the guide rail in a manner that fastens the connector to a connection location on the guide frame.

[0465] Example 24. The system according to example 23, wherein the fixation wire is intracardially withdrawable from the connector of the guide rail to decouple the guide rail from the guide frame.

[0466] Example 25. The system according to example 23, wherein the connector is an eyelet positioned on a distal end portion of the guide rail, and wherein the fixation wire fastens the connector to the connection location on the guide frame by extending out of the guide frame and looping through the eyelet.

[0467] Example 26. The system according to example 25, wherein: (i) the distal end portion is a cap positioned on a distal part of the guide rail, (ii) the implant comprises a tensile member, and a helical member defining multiple turns, (iii) in the guide arrangement, the tensile member extends through the guide rail, the cap being fixedly attached to the tensile member, (iv) the driver is configured to, while the guide rail in the guide arrangement is positioned along a surface of the tissue, anchor the implant along the tissue by screwing the helical member along the guide rail and the tissue such that part of each turn of the helical member becomes embedded within the tissue, and another part of each turn lies above a surface of the tissue, and / or (v) the multiple turns circumscribe a central channel of the helical member, and the delivery assembly is configured to, while the helical member remains anchored along the tissue, retract the guide rail off the cap and out of the helical member, leaving the tensile member extended through the central channel, the tensile member configured to, upon being tensioned, axially contract the helical member.

[0468] Example 27. The system according to example 25, wherein: (i) each of the fasteners is defined by a longitudinal member that extends, from the extracorporeal portion to the distal part of the guide assembly, where the fastener loops around the guide rail, and / or (ii) the fastening, by thefixation wire, of the connector to the connection location inhibits the guide rail from sliding out from the fasteners.

[0469] Example 28. The system according to example 27, wherein: (i) in the guide arrangement, the guide rail lies around a midsection of the guide frame, the midsection disposed axially between an upstream section of the guide frame and a downstream section of the guide frame, (ii) in the delivery state, the connection location is disposed at the downstream section, and / or (iii) the delivery assembly is adapted to transition the guide rail towards the guide arrangement by moving the distal end portion towards the midsection, the fixation wire having sufficient slack to accommodate the moving.

[0470] Example 29. The system according to example 28, wherein: (i) the multiple fasteners are arranged in a series around the guide frame, (ii) a distalmost fastener of the series is connected to the distal end portion, and / or (iii) the delivery assembly is adapted to move the distal end portion towards the midsection by tightening the distalmost fastener of the series.

[0471] Example 30. The system according to example 29, wherein the distalmost fastener of the series is connected to the distal end portion by extending through the eyelet.

[0472] Example 31. The system according to any one of examples 22-30, wherein the guide frame comprises a valve member.

[0473] Example 32. The system according to example 31, wherein the valve member defines multiple prosthetic leaflets.

[0474] Example 33. The system according to example 31, wherein: (i) the guide frame defines an upstream section and a downstream section, and a concave waist disposed axially between the upstream section and the downstream section, (ii) in the expanded state of the guide frame, the waist has a smaller circumference than both the upstream section and the downstream section, and / or (iii) the valve member is positioned within the concave waist.

[0475] Example 34. The system according to any one of examples 22-33, wherein the guide frame defines an articulation zone having increased bending potential.

[0476] Example 35. The system according to example 34, wherein: (i) the guide frame defines multiple struts, and / or (ii) at the articulation zone, the struts have increased flexibility.

[0477] Example 36. The system according to example 34, wherein: (i) the guide frame defines multiple struts, and / or (ii) at the articulation zone, the struts have a smaller crosssection.

[0478] Example 37. The system according to any one of examples 22-36, wherein: (i) the guide frame defines an upstream section and a downstream section, and a concave waist disposed axially between the upstream section and the downstream section, and / or (ii) in the expanded state of the guide frame, the waist has a smaller circumference than both the upstream section and the downstream section.

[0479] Example 38. The system according to example 37, wherein: (i) the delivery assembly comprises at least one constraining wire, (ii) the upstream section is intracardially expandable towards the expanded state while the downstream section is constrained in the delivery state by the constraining wire, and / or (iii) the downstream section is intracardially releasable from the constraining wire such that the downstream section is expandable independently of the upstream section.

[0480] Example 39. The system according to example 37, wherein: (i) the guide assembly comprises multiple actuator wires, operably coupled to the extracorporeal portion, and extending distally to the guide frame, and / or (ii) each of the actuator wires extends to the upstream section of the guide frame, such that actuating the actuator wires by operation of the extracorporeal portion radially expands the upstream section.

[0481] Example 40. The system according to example 39, wherein the guide frame defines a plurality of struts, and wherein each of the actuator wires extend distally through an interior of the guide frame, and are looped through a strut of the upstream section.

[0482] Example 41. The system according to example 39, wherein actuating the actuator wires radially expands the upstream section without expanding the downstream section.

[0483] Example 42. The system according to example 39, wherein the actuator wires are a first set of actuator wires, and wherein the guide assembly further comprises a second set of actuator wires that are operably coupled to the extracorporeal portion, and extend distally to the guide frame, each of the actuator wires of the second set extending to the downstream section of the guide frame, such that actuating the actuator wires of the second set by operation of the extracorporeal portion radially expands the downstream section.

[0484] Example 43. The system according to any one of examples 22-42, wherein: (i) in the guide arrangement, the guide rail lies around a midsection of the guide frame, themidsection disposed axially between an upstream section of the guide frame and a downstream section of the guide frame, and / or (ii) in the expanded state of the guide frame, the downstream section is wider than the upstream section.

[0485] Example 44. The system according to example 43, wherein the downstream section is wider than the midsection.

[0486] Example 45. The system according to example 43, wherein, in the expanded state, the guide frame is mushroom-shaped.

[0487] Example 46. The system according to example 43, wherein, in the expanded state, the downstream section protrudes radially outwards away from the midsection.

[0488] Example 47. The system according to example 43, wherein: (i) the driver is configured to implant the implant along the tissue, over and along the guide rail, and / or (ii) the guide frame is positionable within the heart, in the expanded state, such that the downstream section protrudes radially outwards over a downstream surface of the tissue.

[0489] Example 48. The system according to example 47, wherein the guide assembly is configured to move the guide frame, in the expanded state, in an upstream direction until the downstream section abuts the downstream surface of the tissue to protrude radially outwards over the downstream surface.

[0490] Example 49. The system according to example 47, wherein the guide assembly is configured to move the guide frame, in the expanded state, in a downstream direction such that the downstream section squeezes past the tissue to protrude radially outwards over the downstream surface of the tissue.

[0491] Example 50. The system according to example 43, wherein the delivery assembly comprises a sheath, and wherein the downstream section is expandable while the upstream section is constrained within the sheath.

[0492] Example 51. The system according to any one of examples 22-50, wherein the guide frame is a laser-cut stent.

[0493] Example 52. The system according to example 51, wherein the guide frame defines multiple hinge points therealong.

[0494] Example 53. The system according to example 51, wherein the guide frame is cut from a nitinol tube.

[0495] Example 54. The system according to example 51, wherein:

[0496] the guide frame defines an upstream section and a downstream section, and a concave waist disposed axially between the upstream section and the downstream section, and / or

[0497] in the expanded state of the guide frame, the waist has a smaller circumference than both the upstream section and the downstream section.

[0498] Example 55. The system according to example 54, wherein the guide frame defines an articulation zone axially along the guide frame, the articulation zone defining multiple hinge points.

[0499] Example 56. The system according to example 55, wherein the articulation zone is located at the upstream section of the guide frame.

[0500] Example 57. The system according to example 54, wherein the guide frame comprises a valve member, positioned within the concave waist.

[0501] Example 58. The system according to example 57, wherein the valve member defines multiple prosthetic leaflets.

[0502] Example 59. The system according to example 54, wherein: (i) the guide assembly further comprises a control shaft that extends from the extracorporeal portion and is coupled to the guide frame, and / or (ii) the control shaft is coupled to the guide frame via multiple tethers that extend, from a distal portion of the control shaft, distally to the upstream section.

[0503] Example 60. The system according to example 59, wherein the control shaft is adapted to position the guide frame within the heart such that the guide frame is positioned nonparallel to the distal portion, facilitated by the tethers curving, from the distal portion, to the upstream section.

[0504] Example 61. The system according to example 59, wherein in the expanded state of the guide frame, the tethers diverge from the distal portion, distally to the upstream section.

[0505] Example 62. The system according to example 59, wherein the guide frame and the tethers are cut from a unitary tube.

[0506] Example 63. The system according to example 59, wherein the tethers are chains.

[0507] Example 64. The system according to example 59, wherein the tethers are ribbons.

[0508] Example 65. The system according to example 59, wherein the tethers are interconnected struts.

[0509] Example 66. The system according to any one of examples 22-65, further comprising a motorized drive, couplable to the driver at the extracorporeal portion, and adapted to drive the driver.

[0510] Example 67. The system according to example 66, further comprising a sensor, adapted to output a signal indicative of resistance encountered by the drive during advancement, by the driver, of the implant along the guide rail.

[0511] Example 68. The system according to example 67, wherein: (i) the implant is a helical member, (ii) the driver is configured to advance the helical member along the guide rail by applying torque to the helical member, and / or (iii) the sensor is adapted to output the signal responsively to an amount of torque applied to the driver by the drive.

[0512] Example 69. The system according to example 67, further comprising a control unit, adapted to receive the signal and to provide an output indicative of the signal.

[0513] Example 70. The system according to example 69, wherein: (i) the implant comprises a helical member, (ii) the guide assembly is configured to position, along a surface of the tissue, the guide rail in the guide arrangement, (iii) the driver is configured to, while the guide rail in the guide arrangement is positioned along the surface of the tissue, anchor the implant along the tissue by screwing the helical member along the guide rail and the tissue such that part of each turn of the helical member becomes embedded within the tissue, and another part of each turn lies above a surface of the tissue, and / or (iv) the output is indicative of a path of the helical member along the tissue.

[0514] Example 71. The system according to example 69, wherein: (i) the guide assembly is configured to position, along a surface of the tissue, the guide rail in the guide arrangement, (ii) the driver is configured to, while the guide rail in the guide arrangement is positioned along the surface of the tissue, anchor the implant along the tissue and the guide rail, and / or (iii) the output is indicative of a tissue type of the tissue.

[0515] Example 72. The system according to example 69, wherein: (i) the guide assembly is configured to position, along a surface of the tissue, the guide rail in the guide arrangement, (ii) the driver is configured to, while the guide rail in the guide arrangement is positioned along the surface of the tissue, anchor the implant along the tissue and the guide rail, and / or (iii) the output is indicative of a position of the implant within the heart.

[0516] Example 73. The system according to example 69, wherein, responsively to receiving a signal from the sensor indicative of a significant change in resistance encountered by the driver, the control unit is adapted to provide an alert.

[0517] Example 74. The system according to example 73, wherein, responsively to receiving a signal from the sensor indicative of a sharp increase of resistance encountered by the driver, the control unit is adapted to provide an alert.

[0518] Example 75. The system according to example 69, wherein: (i) the control unit is adapted to control the drive, and / or (ii) responsively to receiving a signal from the sensor indicative of a significant change in resistance encountered by the driver, the control unit is adapted to automatically stop the drive.

[0519] Example 76. The system according to example 75, wherein responsively to receiving a signal from the sensor indicative of a sharp increase of resistance encountered by the driver, the control unit is adapted to automatically stop the drive.

[0520] Example 77. The system according to example 69, wherein the control unit is adapted to determine, responsively to the signal, a change in resistance encountered by the drive over time, and to responsively provide the output.

[0521] Example 78. The system according to example 77, wherein the control unit is adapted to provide the output via a user interface.

[0522] Example 79. The system according to example 78, wherein the control unit is adapted to provide a graph indicative of the change in resistance over time, via the user interface.

[0523] Example 80. The system according to example 69, wherein: (i) the implant further comprises a tensile member, (ii) the system further comprising a tensioning tool that is configured to contract the tissue along which the implant is anchored by applying tension to the tensile member, and / or (iii) the control unit is adapted to provide an indication indicative of a maximum amount of tensioning force for the tensioning tool to apply to the tensile member, responsively to the signal.

[0524] Example 81. The system according to example 69, wherein: (i) the implant further comprises a tensile member, (ii) the system further comprising a tensioning tool that is configured to contract the tissue along which the implant is anchored by applying tension tothe tensile member, (iii) the drive is adapted to apply the tension via the tensioning tool, and / or (iv) the control unit is adapted to apply the tension responsively to the output.

[0525] Example 82. The system according to example 81, wherein, in the guide arrangement, the tensile member extends through the guide rail.

[0526] Example 83. The system according to example 82, wherein: (i) the implant comprises a helical member, (ii) the guide assembly is configured to position, along a surface of the tissue, the guide rail in the guide arrangement, (iii) the driver is configured to, while the guide rail in the guide arrangement is positioned along the surface of the tissue, anchor the implant along the tissue by screwing the helical member along the guide rail and the tissue such that part of each turn of the helical member becomes embedded within the tissue, and another part of each turn lies above a surface of the tissue, (iv) the multiple turns circumscribe a central channel of the helical member, and / or (v) the delivery assembly is configured to, while the helical member remains anchored along the tissue, retract the guide rail out of the helical member, leaving the tensile member extended through the central channel, the tensile member configured to, upon being tensioned, axially contract the helical member.

[0527] Example 84. The system according to example 83, further comprising a stopper coupled to a distal end of the tensile member, such that tension applied to the tensile member longitudinally contracts the helical member by the stopper inhibiting sliding of the tensile member through the central channel.

[0528] Example 85. The system according to example 83, wherein the tensioning tool that is configured to contract the tissue along which the helical member is anchored by axially contracting the helical member.

[0529] Example 86. The system according to any one of examples 22-85, wherein the guide assembly comprises multiple actuator wires, operably coupled to the extracorporeal portion, extending distally through an interior of the guide frame, and attached to a downstream section of the guide frame, such that tensioning the actuator wires from the extracorporeal portion radially expands the guide frame.

[0530] Example 87. The system according to example 86, wherein: (i) in the guide arrangement, the guide rail lies around a midsection of the guide frame, the midsection disposed longitudinally between an upstream section of the guide frame and the downstream section of the guide frame, (ii) the guide assembly further comprises a control shaft thatextends from the extracorporeal portion and is coupled to the upstream section of the guide frame, (iii) the guide frame defines multiple struts, and / or (iv) each of the actuator wires extends, from the control shaft, distally through the interior of the guide frame to the downstream section where the respective actuator wire loops around a respective strut of the guide frame.

[0531] Example 88. The system according to example 87, wherein the guide assembly comprises exactly three actuator wires.

[0532] Example 89. The system according to example 87, wherein each of the actuator wires: (i) extends from the extracorporeal portion, distally along the control shaft, (ii) extends from a distal end of the control shaft, distally through the interior of the guide frame to the downstream section, (iii) at the downstream section, loops around a respective strut, (iv) returns, from the respective strut, proximally through the interior of the guide frame to the control shaft, and / or (v) from the distal end of the control shaft, extends proximally along the control shaft to the extracorporeal portion.

[0533] Example 90. The system according to example 89, wherein the guide assembly comprises exactly three actuator wires, such that the actuator wires form a tripod-like arrangement within the guide frame.

[0534] Example 91. The system according to example 89, wherein each of the actuator wires extends along an exterior of the control shaft.

[0535] Example 92. The system according to example 89, wherein each of the actuator wires extends along the control shaft within a lumen of the control shaft.

[0536] Example 93. The system according to example 87, wherein in the expanded state of the guide frame, at least part of the upstream section is wider than the downstream section.

[0537] Example 94. The system according to example 87, wherein in the expanded state of the guide frame, at least part of the upstream section is wider than the midsection.

[0538] Example 95. The system according to example 87, wherein the guide assembly is configured such that the guide frame is pivotable with respect to the control shaft via differential tensioning of the actuator wires.

[0539] Example 96. The system according to example 95, wherein the extracorporeal portion: (i) comprises at least one controller to which the actuator wires are operativelycoupled, and / or (ii) is configured to differentially actuate the actuator wires via actuation of the at least one controller.

[0540] Example 97. The system according to example 96, wherein: (i) the guide frame is configured to radially expand responsively to balanced tension in the actuator wires, and / or (ii) the extracorporeal portion is configured to apply the balanced tension to the actuator wires.

[0541] Example 98. The system according to example 96, wherein the at least one controller is configured with: (i) a first actuation mode that applies the balanced tension to the actuator wires, and / or (ii) a second actuation mode that applies the differential tension to the actuator wires.

[0542] Example 99. The system according to any one of examples 22-98, wherein each of the fasteners is defined by a longitudinal member that extends, from the extracorporeal portion to the distal part, where the fastener is engaged with the guide rail.

[0543] Example 100. The system according to example 99, wherein: (i) the guide frame defines an interior and has an exterior, and / or (ii) at the distal part, each of the longitudinal members extends from the interior, through the guide frame to the exterior, where the fastener is engaged with the guide rail.

[0544] Example 101. The system according to example 100, wherein: (i) the guide assembly includes multiple rods, each of the multiple rods defining a pair of lumens, and / or (ii) each of the longitudinal members extends, distally through a first lumen of a respective rod, and, at the distal part, out of the first lumen to loop around the guide rail, and proximally back into a second lumen of the respective rod, and proximally through the second lumen.

[0545] Example 102. The system according to example 101, wherein, each rod defines a pair of secondary rods, each of the secondary rods defining a lumen of the pair.

[0546] Example 103. The system according to example 101, wherein each rod defines a singular tubular structure defining the pair of lumens therethrough.

[0547] Example 104. The system according to example 101, wherein, for each rod, the first lumen and the second lumen define a distal opening that is disposed at an inner surface of the guide frame.

[0548] Example 105. The system according to example 101, wherein: (i) the guide frame defines multiple struts, (ii) for each rod, the rod extends through the interior of the guideframe to an interior surface of the guide frame where the first lumen and the second lumen diverge to curve around a respective strut of the guide frame, and / or (iii) each of the first lumen and the second lumen defines a distal opening that is disposed at an exterior surface of the guide frame.

[0549] Example 106. The system according to example 101, wherein the multiple rods are flexible.

[0550] Example 107. The system according to example 101, wherein the multiple rods are longitudinally incompressible.

[0551] Example 108. The system according to example 101, wherein the multiple rods extend distally within the interior.

[0552] Example 109. The system according to any one of examples 22-108, wherein the guide assembly comprises multiple spacers, arranged around the guide frame, and configured to maintain a spacing between the guide rail and the guide frame.

[0553] Example 110. The system according to example 109, wherein: (i) in the guide arrangement, the guide rail lies around a midsection of the guide frame, the midsection disposed longitudinally between an upstream section of the guide frame and a downstream section of the guide frame, and / or (ii) each spacer extends longitudinally alongside part of the upstream section, the entire midsection, and part of the downstream section.

[0554] Example 111. The system according to example 110, wherein each of the spacers is a wire.

[0555] Example 112. The system according to example 110, wherein: (i) each of the spacers is a hollow tube that defines a lumen therethrough, and / or (ii) for each spacer, a respective tether extends, from the upstream section where the tether is attached to the guide frame, through the respective lumen, and out of the lumen where the tether is attached to the downstream section.

[0556] Example 113. The system according to example 112, wherein the guide frame defines multiple struts, and wherein for each spacer, the spacer is attached to the upstream section and the downstream section by the respective tether of the spacer being tied to respective struts of the guide frame.

[0557] Example 114. The system according to example 113, wherein each one of the tethers is a string.

[0558] Example 115. The system according to example 110, wherein, for each spacer, at the downstream section, the spacer enters the guide frame and extends across an interior of the guide frame to an opposite side of the guide frame, where the spacer is attached thereto.

[0559] Example 116. The system according to example 115, wherein, within the interior of the guide frame, the spacers overlap to form a spiral arrangement.

[0560] Example 117. The system according to example 110, wherein the guide assembly comprises exactly twelve spacers.

[0561] Example 118. A method for use with a real or simulated heart of a real or simulated subject, the method comprising: (A) transluminally advancing a guide frame to the heart while the guide frame is secured to a guide rail via multiple fasteners that extend out of the guide frame to the guide rail; (B) expanding the guide frame within the heart; (C) drawing the guide rail into a guide arrangement around at least a part of the guide frame by tightening at least one of the multiple fasteners; (D) imaging the guide frame within the heart to determine a relative position of the guide frame with respect to the heart; and / or (E) responsively to the determining, identifying a suitability of the position of the guide frame for anchoring an implant into tissue of the heart by screwing the implant over and along the guide rail.

[0562] Example 119. The method according to example 118, wherein: (a) in the guide arrangement, the guide rail lies around a midsection of the guide frame, the midsection disposed axially between an upstream section of the guide frame and a downstream section of the guide frame, (b) transluminally advancing the guide frame to the heart comprises transluminally advancing the guide frame to the heart using a control shaft that is coupled to the upstream section of the guide frame, and / or (c) expanding the guide frame within the heart comprises expanding the guide frame by extracorporeally tensioning multiple actuator wires that extend, from the control shaft, distally through an interior of the upstream section of the guide frame, to a downstream section of the guide frame around which the respective actuator wire is looped, and proximally back through the interior of the guide frame to the control shaft.

[0563] Example 120. The method according to any one of examples 118-119, wherein: (a) in the guide arrangement, the guide rail lies around a midsection of the guide frame, the midsection disposed axially between an upstream section of the guide frame and a downstream section of the guide frame, (b) expanding the guide frame within the heart comprises expanding the downstream section downstream of the tissue such that the downstream section defines a ridge, and / or (c) the method further comprises positioning the ridge against a downstream-facing surface of the tissue by pulling the guide frame proximally until the ridge abuts against the downstream-facing surface of the tissue.

[0564] Example 121. The method according to example 120, wherein: (a) the heart comprises an atrium, a ventricle downstream of the atrium, and a valve therebetween, the valve defining an orifice, an annulus circumscribing the orifice, (b) the tissue is tissue of the annulus, (c) expanding the downstream section downstream of the tissue comprises expanding the downstream section within the ventricle, and / or (d) positioning the ridge against the downstream-facing surface of the tissue comprises positioning the ridge against a ventricular-facing surface of the annulus, such that the downstream section protrudes radially over the ventricular-facing surface.

[0565] Example 122. The method according to example 121, wherein the method further comprises, subsequently to positioning the ridge against the downstream-surface of the tissue, expanding the upstream section upstream of the tissue, within the heart.

[0566] Example 123. The method according to example 122, wherein expanding the upstream section comprises expanding the upstream section such that the upstream section presses against an upstream surface of the tissue.

[0567] Example 124. The method according to example 123, wherein expanding the upstream section comprises expanding the upstream section such that the guide frame defines a concave waist disposed axially between the upstream section and the downstream section, the waist having a smaller circumference than both the upstream section and the downstream section.

[0568] Example 125. The method according to example 123, wherein: (a) expanding the downstream section downstream of the tissue comprises expanding the downstream section downstream of the tissue while the upstream section is constrained within a catheter, and / or (b) expanding the upstream section within the atrium comprises releasing the upstream section from the catheter such that the upstream section self-expands within the heart.

[0569] Example 126. The method according to example 123, wherein expanding the upstream section within the atrium comprises tensioning actuator wires that are attached to the upstream section to expand the upstream section.

[0570] Example 127. The method according to any one of examples 118-126, wherein: (i) step (B) comprises partially expanding the guide frame within the heart, while the guide frame is suspended within the heart upstream of the tissue, (ii) step (C) comprises drawing the guide rail into a guide arrangement around the partially expanded guide frame, while theguide frame remains suspended within the heart, upstream of the tissue, (iii) the method further comprises, subsequently to step (C), moving the partially expanded guide frame downstream within the heart, until the guide rail abuts the tissue, and / or (iv) while the guide rail is positioned along the tissue in the guide arrangement, the method further comprises fully expanding the guide frame.

[0571] Example 128. The method according to example 127, wherein fully expanding the guide frame while the guide rail is positioned along the tissue in the guide arrangement comprises fully expanding the guide frame while pushing the guide frame distally to maintain the guide rail against the tissue.

[0572] Example 129. The method according to any one of examples 118-128, wherein: (i) in the guide arrangement, the guide rail lies around a midsection of the guide frame, the midsection disposed axially between an upstream section of the guide frame and a downstream section of the guide frame, (ii) transluminally advancing the guide frame to the heart comprises transluminally advancing the guide frame to the heart using a control shaft that is coupled to the upstream section of the guide frame, and / or (iii) imaging the guide frame within the heart to determine a relative position of the guide frame with respect to the heart comprises imaging the guide frame while pushing the control shaft distally, to determine a movement of the upstream section.

[0573] Example 130. The method according to example 129, wherein: (i) in the expanded state of the guide frame, the upstream section protrudes radially outwards over an upstream surface of the tissue, and / or (ii) imaging the guide frame while pushing the control shaft distally, to determine a movement of the upstream section comprises imaging the guide frame while pushing the control shaft distally, to determine whether the protruding of the upstream section over the upstream surface of the tissue prevents distalward movement.

[0574] Example 131. The method according to example 129, wherein imaging the guide frame while pushing the control shaft distally, to determine a movement of the upstream section comprises imaging the guide frame while pushing the control shaft distally, to determine whether the upstream section becomes inverted around the control shaft.

[0575] Example 132. The method according to example one of examples 97-110, wherein: (i) in the guide arrangement, the guide rail lies around a midsection of the guide frame, the midsection disposed axially between an upstream section of the guide frame and a downstream section of the guide frame, and / or (ii) imaging the guide frame within the heartto determine a relative position of the guide frame with respect to the heart comprises imaging the downstream section over at least a portion of a cardiac cycle of the subject, to determine a movement of the downstream section responsively to the cardiac cycle.

[0576] Example 133. The method according to example 132, wherein: (i) the heart comprises a valve, the valve comprising a plurality of leaflets, and an annulus, the tissue being tissue of the annulus, and / or (ii) imaging the downstream section over at least a portion of the cardiac cycle comprises imaging the downstream section over at least a portion of a systolic phase of the cardiac cycle, to determine whether the downstream section becomes radially compressed, responsively to leaflets of the valve converging medially within the valve.

[0577] Example 134. The method according to example 133, wherein: (i) the guide frame defines a concave waist disposed axially between the upstream section and the downstream section, and / or (ii) expanding the guide frame within the heart comprises expanding the guide frame within the heart such that the waist has a smaller circumference than both the upstream section and the downstream section.

[0578] 135 An apparatus for use with a cardiovascular system, the apparatus comprising: (i) an implant, (ii) a driver for advancing the implant into tissue of the cardiovascular system, (iii) a drive, couplable to the driver at an extracorporeal portion of the apparatus, and adapted to drive the driver, (iv) a sensor, adapted to output a signal indicative of resistance encountered by the drive during advancement, by the driver, of the implant into the tissue, (v) an adjustment tool, adapted to contract the implant while the implant is implanted in the tissue, and / or (vi) a control unit, adapted to receive the signal and to provide, responsively to the signal, an output indicative of a maximum amount of contracting force for the adjustment tool to apply to the implant.

[0579] Example 136. A system for use with a valve of a heart of a subject, the system comprising: (i) a guide rail; (ii) a frame; (iii) a plurality of loops adapted to intracardially position the guide rail into a guide arrangement circumferentially around the frame; (iv) a flexible helical member defining multiple turns; and / or (v) a driver, adapted to, while the guide rail (a) is in the guide arrangement and (b) lies along a surface of a tissue of the valve, anchor the helical member to the tissue, by screwing the helical member over and along the guide rail around the frame, such that part of each turn of the helical member becomes embedded within the tissue and another part of each turn lies above the surface of the tissue,wherein the frame comprises a valve member secured to an interior of the frame, the valve member comprising multiple leaflets.

[0580] Example 137. The system according to example 136, wherein the guide frame is a laser-cut stent.

[0581] Example 138. The system according to example 137, wherein the guide frame defines multiple hinge points therealong.

[0582] Example 139. The system according to example 137, wherein the guide frame is cut from a nitinol tube.

[0583] Example 140. The system according to example 137, wherein: (i) the guide frame defines an upstream section and a downstream section, and a concave waist disposed axially between the upstream section and the downstream section, and / or (ii) in the expanded state of the guide frame, the waist has a smaller circumference than both the upstream section and the downstream section.

[0584] Example 141. The system according to example 140, wherein the guide frame defines an articulation zone axially along the guide frame, the articulation zone defining multiple hinge points.

[0585] Example 142. The system according to example 141, wherein the articulation zone is located at the upstream section of the guide frame.

[0586] Example 143. The system according to example 140, wherein the valve member is positioned within the concave waist.

[0587] Example 144. The system according to example 143, wherein the valve member defines multiple prosthetic leaflets.

[0588] Example 145. The system according to example 140, wherein: (i) the guide assembly further comprises a control shaft that extends from the extracorporeal portion and is coupled to the guide frame, and / or (ii) the control shaft is coupled to the guide frame via multiple tethers that extend, from a distal portion of the control shaft, distally to the upstream section.

[0589] Example 146. The system according to example 145, wherein the control shaft is adapted to position the guide frame within the heart such that the guide frame is positioned nonparallel to the distal portion, facilitated by the tethers curving, from the distal portion, to the upstream section.

[0590] Example 147. The system according to example 145, wherein in the expanded state of the guide frame, the tethers diverge from the distal portion, distally to the upstream section.

[0591] Example 148. The system according to example 145, wherein the guide frame and the tethers are cut from a unitary tube.

[0592] Example 149. The system according to example 145, wherein the tethers are chains.

[0593] Example 150. The system according to example 145, wherein the tethers are ribbons.

[0594] Example 151. The system according to example 145, wherein the tethers are interconnected struts.

[0595] Example 152. A system for use with tissue of a heart, the system comprising: (a) an implant; and / or (b) a delivery assembly comprising: (i) a handle, (ii) a guide assembly, having a distal part that is transluminally advanceable to the heart while in a delivery state, the guide assembly comprising: (I) a guide frame, intracardially: (a) expandable, using an expansion-control device on the handle, toward an expanded state via, and / or (b) advanceable distally towards the tissue, using an advancement-control device on the handle, (II) a guide rail, and / or (III) multiple fasteners that are intracardially tightenable, from a handle of the delivery assembly, in a manner that draws the guide rail into a guide arrangement around at least part of the guide frame, (iii) a driver, configured to advance the implant along the guide rail in the guide arrangement, and / or (iv) a mechanism on the handle adapted to mate the expansion-control device with the advancement-control device such that operation of the expansion-control device concurrently operates the advancement-control device.

[0596] Example 153. A system for use with tissue of a heart, the system comprising: (a) an implant; and / or (b) a delivery assembly comprising: (i) a handle, (ii) a guide assembly, having a distal part that is transluminally advanceable to the heart while in a delivery state, the guide assembly comprising: (I) a guide frame, intracardially expandable toward an expanded state, (II) a guide rail, (III) multiple fasteners, and / or (IV) a fastener-puller at the handle, adapted to intracardially tighten the fasteners, via a single operation of the fastenerpuller, in a manner that draws the guide rail into a guide arrangement around at least part of the guide frame by the single operation simultaneously pulling the fasteners, and / or (iii) a driver, configured to advance the implant along the guide rail in the guide arrangement.

[0597] Example 154. A system for use with tissue of a heart, the system comprising: (a) a helical member defining a head, and a helix extending away from the head; and / or (b) a delivery assembly comprising: (i) a guide assembly, having a distal part that is transluminally advanceable to the heart, the guide assembly comprising a guide rail, (ii) a driver, reversibly coupled to the helical member at the head, and configured to, while the guide rail is positioned along a surface of the tissue, anchor the helical member along the tissue by screwing the helical member over and along the guide rail and the tissue such that part of each turn of the helical member becomes embedded within the tissue, and another part of each turn lies above a surface of the tissue, wherein, the driver is coupled to the head in a manner in which withdrawing the guide rail out of the helical member and the head decouples the driver from the helical member.

[0598] Example 155. The system according to example 154, wherein the driver defines a driveshaft and a drivehead at a distal end of the driveshaft, the drivehead adapted to be reversibly coupled to the head.

[0599] Example 156. The system according to example 155, wherein, (i) the drivehead defines one or more arms that are biased to deflect medially upon retraction of the guide rail, (ii) the guide rail is adapted to reversibly couple the drivehead to the head by extending through the drivehead such that the arms are deflected radially outwards, thereby maintaining the arms in engagement with an interior surface of the head.

[0600] Example 157. The system according to example 154, wherein the guide assembly further comprises a frame, the guide rail intracardially positionable around the frame in a manner that positions the guide rail along the tissue.

[0601] Example 158. A system for use with a heart of a subject, the system comprising: (a) a structure for use with the heart, and / or (b) a delivery tool comprising: (i) a shaft having a distal end that is attached to the structure, (ii) a constrictor adapted to compress the structure into a compressed state, the shaft extending through the constrictor in a manner in which axially sliding the shaft with respect to the constrictor slides the structure into the constrictor, and / or (iii) a catheter: (I) transluminally advanceable to the heart, and / or (II) defining a port into which a distally-facing nozzle of the constrictor is advanceable such that the structure, while in its compressed state, is advanceable to the heart, out of the constrictor, and through the port and the catheter.

[0602] Example 159. A system for use with a valve of a heart of a subject, the system comprising: (i) a guide rail; (ii) a frame, defining an upstream section and a downstream section, and a midsection therebetween; (iii) a plurality of loops adapted to intracardially position the guide rail into a guide arrangement circumferentially around a midsection of the frame; (iv) a flexible helical member defining multiple turns; and / or (v) a driver, adapted to, while the guide rail (a) is in the guide arrangement, and (b) lies along a surface of a tissue of the valve, anchor the helical member to the tissue, by screwing the helical member over and along the guide rail around the frame, such that part of each turn of the helical member becomes embedded within the tissue and another part of each turn lies above the surface of the tissue, wherein: (I) the frame comprises a valve member secured to an interior of the frame, the valve member comprising multiple leaflets, (II) the upstream section and the downstream section are defined by an array of struts that define a cellular arrangement, and / or (II) the midsection is defined by struts that extend vertically between the upstream section and the downstream section, parallel with each other and with a longitudinal axis of the frame.

[0603] Example 160: The system according to example 159, wherein, in an expanded state of the frame, the midsection has a smaller circumference than both the upstream section and the downstream section.

[0604] Example 161. A system for use with tissue of an annulus of a native valve of a heart, the system comprising: (a) an implant comprising: (i) a helical member; and / or (ii) a prosthetic heart valve; and / or (b) a delivery assembly comprising: (i) a guide assembly, having a distal part that is transluminally advanceable to the heart while in a delivery state, the guide assembly comprising: (I) a guide frame, intracardially expandable toward an expanded state, (II) a guide rail, and / or (III) multiple fasteners that are intracardially tightenable, from a proximal extracorporeal portion of the delivery assembly, in a manner that draws the guide rail into a guide arrangement around at least part of the guide frame, and / or (ii) a driver, configured to, while the guide rail is positioned along a surface of the tissue, anchor the helical member around the annulus by screwing the helical member over and along the guide rail and the tissue such that part of each turn of the helical member becomes embedded within the tissue, and another part of each turn lies above a surface of the tissue, the prosthetic heart valve being positionable within the native valve by positioning the prosthetic heart valve circumferentially within anchored helical member.

[0605] Example 162. A system for use with a valve of a heart of a subject, the system comprising: (i) a guide rail; (ii) a frame; (iii) a plurality of loops adapted to intracardially position the guide rail into a guide arrangement circumferentially around the frame; (iv) a flexible helical member defining multiple turns; and / or (v) a driver, adapted to, while the guide rail (a) is in the guide arrangement and (b) lies along a surface of a tissue of the valve, anchor the helical member to the tissue, by screwing the helical member over and along the guide rail around the frame.

[0606] Example 163. The system of example 162, further comprising a handle, wherein the frame is (a) expandable, using an expansion-control device on the handle, toward an expanded state via, and / or (b) advanceable distally towards the tissue, using an advancement-control device on the handle.

[0607] Example 164. The system of example 163, wherein the handle comprises a mechanism on the handle adapted to mate the expansion-control device with the advancement-control device such that operation of the expansion-control device concurrently operates the advancement-control device.

[0608] Example 165. The system of any of examples 163-164, wherein the handle comprises a fastener-puller adapted to intracardially tighten the plurality of loops, via a single operation of the fastener-puller, in a manner that draws the guide rail into the guide arrangement around at least part of the frame by the single operation simultaneously pulling the plurality of loops.

[0609] Example 166. The system of any of examples 162-165, further comprising (a) a shaft and (b) a constrictor, the constrictor adapted to compress the frame into a compressed state, the shaft extending through the constrictor in a manner in which axially sliding the shaft with respect to the constrictor slides the frame into the constrictor.

[0610] Example 167. The system of example 166, further comprising a catheter that is (I) transluminally advanceable to the heart, and / or (II) defining a port into which a distally- facing nozzle of the constrictor is advanceable such that the frame, while in its compressed state, is advanceable to the heart, out of the constrictor, and through the port and the catheter.

[0611] Example 168. The system of any of examples 162-167, wherein the plurality of loops are intracardially tightenable, from a proximal extracorporeal portion of a delivery assembly of the system, in a manner that draws the guide rail into a guide arrangement around at least part of the frame.

[0612] Example 169. The system of any of examples 162-168, wherein the driver is configured to, while the guide rail is positioned along a surface of the tissue, anchor the helical member around the annulus of the valve by screwing the helical member over and along the guide rail and the tissue such that part of each turn of the helical member becomes embedded within the tissue, and another part of each turn lies above a surface of the tissue.

[0613] Example 170. The system of any of examples 162-169, wherein the frame comprises wherein the frame comprises a valve member secured to an interior of the frame. The valve member can comprise multiple leaflets.

[0614] Example 171. The system of any of examples 162-170, further comprising: (a) a control unit, comprising: (i) a motorized drive, couplable to the driver at an extracorporeal portion of the apparatus, and adapted to drive the driver to drive the helical member into the tissue, (ii) a sensor, adapted to sense resistance encountered by the drive during the driving of the helical member into the tissue, and to provide a signal indicative of the resistance.

[0615] In the present disclosure, the term data-processing system may refer to, be part of, or include an Application Specific Integrated Circuit (ASIC); a digital, analog, or mixed analog / digital discrete circuit; a digital, analog, or mixed analog / digital integrated circuit; a combinational logic circuit; a field programmable gate array (FPGA); a processor (shared, dedicated, group) that executes code; memory (shared, dedicated, or group) that stores code executed by a processor; other suitable hardware components, such as optical, magnetic, or solid state drives, that provide the described functionality; or a combination of some or all of the above, such as in a system-on-chip. The term code, as used above, may include software, firmware, and / or microcode, and may refer to programs, routines, algorithms, functions, classes, and / or objects. The term shared processor encompasses a single processor that executes some or all code from multiple modules. The term group processor encompasses a processor that, in combination with additional circuitry (e.g., processors), executes some or all code from one or more modules. The term shared memory encompasses a single memory that stores some or all code from multiple modules. The term group memory encompasses a memory that, in combination with additional memories, stores some or all code from one or more modules. The term memory may be subset of the term computer- readable medium. The term computer-readable medium does not encompass transitory electrical and electromagnetic signals propagating through a medium, and may therefore be considered tangible and non -transitory. Non-limiting examples of a non-transitory tangiblecomputer readable medium include nonvolatile memory, volatile memory, magnetic storage, and optical storage.

[0616] Any of the various systems, assemblies, devices, components, apparatuses, etc. in this disclosure can be sterilized (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure they are safe for use with patients, and the methods herein can comprise (or additional methods comprise or consist of) sterilization of the associated system, device, component, apparatus, etc. (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.).

[0617] The techniques, methods, processes, operations, steps, etc. described or suggested herein or in the references incorporated herein, and any methods of using the systems, assemblies, apparatuses, devices, etc. herein, can be performed on a living subject (e.g., human, other animal, etc.) or on a simulation (e.g., a cadaver, cadaver heart, simulator, imaginary person, etc.). When performed on a simulation, the body parts, e.g., heart, tissue, valve, etc., can be assumed to be simulated or can optionally be referred to as “simulated” (e.g., simulated heart, simulated tissue, simulated valve, etc.) and can optionally comprise computerized and / or physical representations of body parts, tissue, etc. The term “simulation” covers use on a cadaver, computer simulator, imaginary person (e.g., if they are just demonstrating in the air on an imaginary heart), etc.

[0618] Various implementations of systems, devices, methods, etc. are disclosed herein, and any combination of their features, components, and options can be made unless specifically excluded. In short, individual components of the disclosed systems can be combined unless mutually exclusive or physically impossible.

[0619] Although the operations of some of the disclosed methods are described in a particular, sequential order for convenient presentation, it should be understood that this manner of description encompasses rearrangement, unless a particular ordering is required by specific language set forth herein. For example, operations described sequentially can in some cases be rearranged or performed concurrently. Moreover, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed systems, apparatuses, devices, methods, etc. can be used in conjunction with other systems, apparatuses, devices, methods, etc.

[0620] The present disclosure is not limited to the examples that have been particularly shown and described hereinabove. Rather, the scope of the present disclosure includes bothcombinations and subcombinations of the various features described hereinabove, as well as variations and modifications thereof that are not in the prior art, which would occur to persons skilled in the art upon reading the foregoing description.

[0621] The described systems, apparatuses, devices, methods, etc. should not be construed as limiting in any way. Instead, the present disclosure is directed toward all novel and nonobvious features and aspects of the various disclosed implementations and applications, alone and in various combinations and sub-combinations with one another. The disclosed systems, apparatuses, devices, methods, etc. are not limited to any specific aspect, feature, or combination thereof, nor do the disclosed systems, apparatuses, devices, methods, etc. require that any one or more specific advantages be present or problems be solved.

Claims

1. CLAIMS1. An apparatus for use with a cardiovascular system, the apparatus comprising: an implant; a driver for driving the implant into tissue of the cardiovascular system; an adjustment tool, adapted to contract the tissue by applying a contracting force to the implant while the implant remains in the tissue; and a control unit, comprising: a motorized drive, couplable to the driver at an extracorporeal portion of the apparatus, and adapted to drive the driver to drive the implant into the tissue, a sensor, adapted to sense resistance encountered by the drive during the driving of the implant into the tissue, and to provide a signal indicative of the resistance, and a data-processing system adapted to receive the signal and, responsively to the signal, provide an output indicative of a magnitude limit for the contracting force to be applied by the adjustment tool.

2. The apparatus according to claim 1, wherein: the apparatus further comprises a guide assembly that comprises a guide rail, the guide assembly is configured to position the guide rail along a surface of the tissue, in a guide arrangement, and the driver is configured to, while the guide rail in the guide arrangement is positioned along the surface of the tissue, anchor the implant along the tissue and the guide rail.

3. The apparatus according to claim 2, wherein: the implant comprises a helical member, the driver is configured to, while the guide rail in the guide arrangement is positioned along the surface of the tissue, anchor the implant along the tissue by screwing the helical member along the guide rail and the tissue such that part of each turn of the helical member becomes embedded within the tissue, and another part of each turn lies above a surface of the tissue, and the output is indicative of a path of the helical member along the tissue.

4. The apparatus according to any one of claims 1-3, wherein the output is indicative of a tissue type of the tissue.

5. The apparatus according to any one of claims 1-4, wherein:the implant is a helical member defining multiple turns, the driver is configured to advance the helical member into the tissue by applying torque to the helical member, and the sensor is adapted to output the signal responsively to an amount of torque applied to the driver by the drive.

6. The apparatus according to claim 5, wherein the adjustment tool is adapted to contract the tissue by axially contracting the implant.

7. The apparatus according to claim 5, wherein the adjustment tool is adapted to contract the tissue by axially contracting the helical member such that the multiple turns move towards each other.

8. The apparatus according to any one of claims 1-7, wherein the output is indicative of a position of the implant within the cardiovascular system.

9. The apparatus according to any one of claims 1-8, wherein, responsively to receiving a signal from the sensor indicative of a significant change in resistance encountered by the driver, the control unit is adapted to provide an alert.

10. The apparatus according to any one of claims 1-9, wherein, responsively to receiving a signal from the sensor indicative of a sharp increase of resistance encountered by the driver, the control unit is adapted to provide an alert.

11. The apparatus according to any one of claims 1-10, wherein: the data-processing system is adapted to control the drive, and responsively to receiving a signal from the sensor indicative of a significant change in resistance encountered by the driver, the data-processing system is adapted to automatically stop the drive.

12. The apparatus according to claim 11, wherein responsively to receiving a signal from the sensor indicative of a sharp increase of resistance encountered by the driver, the data- processing system is adapted to automatically stop the drive.

13. The apparatus according to any one of claims 1-12, wherein the control unit is adapted to determine, responsively to the signal, a change in resistance encountered by the drive over time, and to responsively provide the output.

14. The apparatus according to claim 13, wherein the control unit is adapted to provide the output via a user interface.

15. The apparatus according to claim 14, wherein the control unit is adapted to provide a graph indicative of the change in resistance over time, via the user interface.

16. The apparatus according to any one of claims 1-15, wherein: the implant further comprises a tensile member, and the adjustment tool is adapted to contract the tissue along which the implant is anchored by applying tension to the tensile member such that the implant becomes contracted.

17. The apparatus according to claim 16, wherein: the drive is adapted to apply the tension via the adjustment tool, and the control unit is adapted to apply the tension responsively to the output.

18. The apparatus according to claim 16, wherein: the apparatus further comprises a guide assembly that comprises a guide rail, the guide assembly is configured to position the guide rail along a surface of the tissue, in a guide arrangement, the driver is configured to, while the guide rail in the guide arrangement is positioned along the surface of the tissue, anchor the implant along the tissue and the guide rail, and in the guide arrangement, the tensile member extends through the guide rail.

19. The apparatus according to claim 16, wherein: the implant comprises a helical member defining multiple turns, the driver is configured to anchor the implant along the tissue by screwing the helical member along the tissue such that: part of each turn of the helical member becomes embedded within the tissue, and another part of each turn lies above a surface of the tissue, the multiple turns circumscribe a central channel of the helical member, and the tensile member extends through the central channel, and the tensile member is configured to, upon being tensioned, axially contract the helical member.

20. The apparatus according to claim 19, wherein the tensile member is configured to, upon being tensioned, axially contract the helical member such that multiple turns move towards each other.

21. The apparatus according to claim 19, further comprising a stopper coupled to a distal end of the tensile member, such that tension applied to the tensile member longitudinallycontracts the helical member by the stopper inhibiting sliding of the tensile member through the central channel.

22. The apparatus according to claim 19, wherein the adjustment tool is configured to contract the tissue along which the helical member is anchored by axially contracting the helical member.

23. An apparatus for use with a cardiovascular system, the apparatus comprising: an implant; a guide assembly, having a distal part that is transluminally advanceable to the cardiovascular system while in a delivery state, the guide assembly comprising a guide rail that is positionable along tissue of the cardiovascular system; a driver for driving the implant into the tissue by advancing the implant over and along the guide rail in a first direction; and a control unit, comprising: a motorized drive, couplable to the driver at an extracorporeal portion of the apparatus, and adapted to drive the driver to drive the implant into the tissue, and a sensor, adapted to sense resistance encountered by the drive during the driving of the implant into the tissue, and to provide a signal indicative of the resistance.

24. An apparatus for use with a cardiovascular system, the apparatus comprising: an implant; a guide assembly, having a distal part that is transluminally advanceable to the cardiovascular system while in a delivery state, the guide assembly comprising a guide rail that is positionable along tissue of the cardiovascular system; a driver for screwing the implant into the tissue by advancing the implant over and along the guide rail in a forward direction; and a control unit, comprising: a motorized drive, couplable to the driver at an extracorporeal portion of the apparatus, and adapted to drive the driver, a sensor, adapted to sense resistance encountered by the drive during the driving of the implant into the tissue, and to output a signal indicative of an obstruction event encountered by the drive during the driving, the resistance event being indicative of a tip of the implant encountering an obstruction, anda data-processing system adapted to perform a release procedure responsively to the signal, the release procedure comprising: reversing the drive to unscrew the implant along the guide rail in a reverse direction such that the tip reverses away from the obstruction, and subsequently operating the drive to re-screw the implant over and along the guide rail in the forward direction such that the tip passes the obstruction.

25. A system for use with tissue of a heart, the system comprising: an implant; and a delivery assembly comprising: a guide assembly, having a distal part that is transluminally advanceable to the heart while in a delivery state, the guide assembly comprising: a guide frame, intracardially expandable toward an expanded state, a guide rail, and multiple fasteners that are intracardially tightenable, from a proximal extracorporeal portion of the delivery assembly, in a manner that draws the guide rail into a guide arrangement around at least part of the guide frame, and a driver, configured to advance the implant along the guide rail in the guide arrangement.

26. The system according to claim 25, wherein the delivery assembly further comprises a fixation wire that is connected to a connector of the guide rail in a manner that fastens the connector to a connection location on the guide frame.

27. The system according to claim 26, wherein the connector is an eyelet positioned on a distal end portion of the guide rail, and wherein the fixation wire fastens the connector to the connection location on the guide frame by extending out of the guide frame and looping through the eyelet.

28. The system according to claim 27, wherein: the distal end portion is a cap positioned on a distal part of the guide rail, the implant comprises a tensile member, and a helical member defining multiple turns, in the guide arrangement, the tensile member extends through the guide rail, the cap being fixedly attached to the tensile member,the driver is configured to, while the guide rail in the guide arrangement is positioned along a surface of the tissue, anchor the implant along the tissue by screwing the helical member along the guide rail and the tissue such that part of each turn of the helical member becomes embedded within the tissue, and another part of each turn lies above a surface of the tissue, and the multiple turns circumscribe a central channel of the helical member, and the delivery assembly is configured to, while the helical member remains anchored along the tissue, retract the guide rail off the cap and out of the helical member, leaving the tensile member extended through the central channel, the tensile member configured to, upon being tensioned, axially contract the helical member.

29. The system according to any one of claims 25-28, wherein the guide frame comprises a valve member.

30. The system according to any one of claims 25-29, wherein: the guide frame defines an upstream section and a downstream section, and a concave waist disposed axially between the upstream section and the downstream section, and in the expanded state of the guide frame, the waist has a smaller circumference than both the upstream section and the downstream section.

31. The system according to claim 30, wherein: the delivery assembly comprises at least one constraining wire, the upstream section is intracardially expandable towards the expanded state while the downstream section is constrained in the delivery state by the constraining wire, and the downstream section is intracardially releasable from the constraining wire such that the downstream section is expandable independently of the upstream section.

32. The system according to any one of claims 25-31, wherein: in the guide arrangement, the guide rail lies around a midsection of the guide frame, the midsection disposed axially between an upstream section of the guide frame and a downstream section of the guide frame, and in the expanded state of the guide frame, the downstream section is wider than the upstream section.

33. The system according to any one of claims 25-32, wherein the guide frame is a lasercut stent.

34. The system according to any one of claims 25-33, wherein the guide assembly comprises multiple actuator wires, operably coupled to the extracorporeal portion, extending distally through an interior of the guide frame, and attached to a downstream section of the guide frame, such that tensioning the actuator wires from the extracorporeal portion radially expands the guide frame.

35. The system according to claim 34, wherein: in the guide arrangement, the guide rail lies around a midsection of the guide frame, the midsection disposed longitudinally between an upstream section of the guide frame and the downstream section of the guide frame, the guide assembly further comprises a control shaft that extends from the extracorporeal portion and is coupled to the upstream section of the guide frame, the guide frame defines multiple struts, and each of the actuator wires extends, from the control shaft, distally through the interior of the guide frame to the downstream section where the respective actuator wire loops around a respective strut of the guide frame.

36. The system according to claim 35, wherein the guide assembly comprises exactly three actuator wires.

37. The system according to any one of claims 25-36, wherein each of the fasteners is defined by a longitudinal member that extends, from the extracorporeal portion to the distal part, where the fastener is engaged with the guide rail.

38. The system according to claim 37, wherein: the guide frame defines an interior and has an exterior, and at the distal part, each of the longitudinal members extends from the interior, through the guide frame to the exterior, where the fastener is engaged with the guide rail.

39. The system according to claim 38, wherein: the guide assembly includes multiple rods, each of the multiple rods defining a pair of lumens, and each of the longitudinal members extends, distally through a first lumen of a respective rod, and, at the distal part, out of the first lumen to loop around the guide rail, and proximally back into a second lumen of the respective rod, and proximally through the second lumen.

40. The system according to any one of claims 25-39, wherein the guide assembly comprises multiple spacers, arranged around the guide frame, and configured to maintain a spacing between the guide rail and the guide frame.

41. The system according to claim 40, wherein: in the guide arrangement, the guide rail lies around a midsection of the guide frame, the midsection disposed longitudinally between an upstream section of the guide frame and a downstream section of the guide frame, and each spacer extends longitudinally alongside part of the upstream section, the entire midsection, and part of the downstream section.

42. The system according to claim 41, wherein, for each spacer, at the downstream section, the spacer enters the guide frame and extends across an interior of the guide frame to an opposite side of the guide frame, where the spacer is attached thereto.

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