Anchoring indicator

Abstract

A system (400) for use at a heart of a subject comprises an anchor (420) that comprises a tissue-engaging element (424) and a head (422). The anchor head comprises a piezoelectric inclusion (430). The system comprises a driver (410) that is adapted to, via engagement between the head and the driver: (a) drive the tissue-engaging element into tissue of the heart until the head presses against a surface of the tissue, the piezoelectric inclusion configured to generate piezoelectricity responsively to the pressing of the head against the tissue; and (b) conduct the piezoelectricity from the head to a proximal part of the driver. The system also comprises a sensor that is adapted to sense the conducted piezoelectricity. Other implementations are also described.

Description

ANCHORING INDICATORCROSS-REFERENCES TO RELATED APPLICATIONS

[0001] The present application claims priority to:Provisional US Patent Application 63 / 696,813 to Aviv et al., titled "Anchoring indicator," filed September 19, 2024; andProvisional US Patent Application 63 / 822,789 to Aviv et al., titled "Anchoring indicator," filed lune 12, 2025.

[0002] Each of the above applications is incorporated herein by reference in its entirety for all purposes.BACKGROUND

[0003] Dilation of an annulus of a heart valve may occur due to various heart conditions, such as an enlarged heart chamber or a leaking heart valve. An annuloplasty procedure may be necessary to reshape, reinforce or tighten the annulus. Annuloplasty may be performed by implanting an annuloplasty implant to re-shape and / or re-size the annulus, for example, to reduce the size of the annulus.

[0004] Tissue anchors can be used to facilitate implantation of such annuloplasty implants, such as by coupling such implants to tissue of the heart. An anchor may be driven through the implant and into the tissue while the implant is held in place. Alternatively, the anchor may be implanted before introduction of the implant, and the implant subsequently coupled to the anchor.

[0005] Tissue anchors can also be used to facilitate implantation of other cardiac implants, such as other annulus-anchored implants.SUMMARY

[0006] This summary is meant to provide some examples and is not intended to be limiting of the scope of the invention 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 andsteps as described elsewhere in this disclosure may be included in the examples summarized here.

[0007] Any of the techniques, methods, operations, steps, etc. described or suggested herein can be performed on a living animal (e.g., human, other mammal, etc.) or on a non-living simulation such as a cadaver, a cadaver heart, an anthropomorphic ghost, and / or a simulator device (which can include computerized and / or physical representations of body parts, tissue, etc.)

[0008] In accordance with some implementations, an anchor (e.g., which optionally can be part of a system and / or an implant) defines a head and a tissue-engaging element. In some implementations, the tissue-engaging element extends away from the head to define an anchor axis of the anchor. The anchor can include an indicator (such as an imaging marker, a piezoelectric inclusion, a radiopaque marker, a disk, etc.). The indicator can be the same as or similar to any of the indicators, imaging related markers, piezoelectric inclusions, etc. anywhere in this disclosure. In some implementations, the indicator can be coupled to and / or mounted at the head.

[0009] The indicator can be adapted to move responsively to the anchor (e.g., the tissueengaging element thereof) being inserted in tissue of a subject (e.g., a living subject, a simulation, etc.).

[0010] In some implementations, the indicator is adapted to move with respect to the head, responsively to the anchor being inserted in tissue of a subject (e.g., a living subject, a simulation, etc.).

[0011] In some implementations, the indicator is a disk positioned at a tissue-facing surface of the head.

[0012] In some implementations, the indicator includes one or more radiopaque elements. In some implementations, the one or more radiopaque elements can extend around a perimeter of the disk.

[0013] In some implementations, the indicator is a disk positioned at a tissue-facing surface of the head. In some implementations, the indicator includes a radiopaque element that extends in a spiral along a surface of the disk.

[0014] In some implementations, the indicator is a disk positioned at a tissue-facing surface of the head. In some implementations, the indicator includes multiple radiopaque elements that extend concentrically around a surface of the disk.

[0015] In some implementations, the indicator is one or more balloons positioned at a tissuefacing surface of the head whereby anchoring the tissue-engaging element into the tissue causes the balloon(s) to become sandwiched between the head and the tissue, thereby changing a shape of the balloon(s).

[0016] In some implementations, the indicator is a disk positioned at a tissue-facing surface of the head whereby anchoring the tissue-engaging element into the tissue causes the disk to aggregate around the head.

[0017] In some implementations, the indicator is a disk positioned at a tissue-facing surface of the head whereby anchoring the tissue-engaging element into the tissue causes the disk to cup around the head.

[0018] In some implementations, the indicator is a disk positioned at a tissue-facing surface of the head whereby submerging the head in the tissue causes the disk to curl around the head.

[0019] In some implementations, the indicator is a disk positioned at a tissue-facing surface of the head, and the disk is included of a fabric.

[0020] In some implementations, the indicator is a disk positioned at a tissue-facing surface of the head, and the disk is comprised of a material.

[0021] In some implementations, the material can comprise a fabric, a yam, a thread, a radiopaque material, a radiopaque wire, a radiopaque marker, a metal, a polymer, etc.

[0022] In some implementations, the indicator is a fabric disk positioned at a tissue-facing surface of the head.

[0023] In some implementations, the indicator includes a compressible layer.

[0024] In some implementations, the indicator includes a first radiopaque layer. In some implementations, the indicator includes a second radiopaque layer separated from the first radiopaque layer by the compressible layer.

[0025] In some implementations, the indicator is mounted on the anchor whereby anchoring the tissue-engaging element into the tissue causes the indicator to become sandwiched between the head and the tissue, such that the compressible layer becomes compressed.

[0026] In some implementations, as the compressible layer becomes compressed, the first and second radiopaque layers move towards each other.

[0027] In some implementations, the indicator includes an imaging element that is connected to the head via a cord, such that the imaging element is adapted to change position with respect to the head, responsively to the anchor (e.g., tissue-engaging element) being inserted in the tissue, by remaining above a surface of the tissue.

[0028] In some implementations, the cord is radiopaque.

[0029] In some implementations, the imaging element is radiopaque.

[0030] In some implementations, the indicator is a compressible layer positioned at a tissuefacing surface of the head whereby anchoring the tissue-engaging element into the tissue causes the compressible layer to become sandwiched between the head and the tissue, thereby compressing the compressible layer.

[0031] In some implementations, the compressible layer is a cushion.

[0032] In some implementations, the indicator is a wave spring.

[0033] In some implementations, the indicator is a disk positioned at a tissue-facing surface of the head. In some implementations, the anchor is anchorable into the tissue while the indicator is in a first cupped state in which the disk defines a concavity that faces towards the tissue. In some implementations, the indicator is transitionable towards a second cupped state, responsively to the anchor (e.g., tissue-engaging element thereof) being inserted in the tissue, in which the disk defines a concavity that faces away from the tissue.

[0034] In some implementations, the disk is a bi-stable disk that is transitionable between the first cupped state and the second cupped state.

[0035] In some implementations, the indicator is transitionable to a flattened state, responsively to the disk contacting the tissue and becoming sandwiched between the head and the tissue.

[0036] In some implementations, the indicator is transitionable to any discrete position between the first cupped state and the second cupped state.

[0037] In some implementations, the indicator is a disk positioned at a tissue-facing surface of the head, and the indicator includes a radiopaque element that is woven along a surface of the disk.

[0038] In some implementations, the radiopaque element is a wire.

[0039] In some implementations, the radiopaque element is a radiopaque thread.

[0040] In some implementations, the anchor is part of a system that also includes a driver adapted to anchor the tissue-engaging element into tissue of a subject (e.g., a living subject, a simulation, etc.). The driver can be the same as or similar to any of the drivers described anywhere herein.

[0041] In some implementations, the system further includes a catheter. The catheter can be the same as or similar to any of the catheters disclosed anywhere herein or otherwise known.

[0042] In some implementations, the catheter has a distal portion that comprises a radiopaque proximal marker. In some implementations, the catheter has a distal portion that comprises a radiopaque distal marker.

[0043] In some implementations, the catheter comprises a compressible zone between the proximal marker and the distal marker.

[0044] In some implementations, the catheter is configured such that, via application and release of an axially-compressive force to the distal portion, the distal portion is reversibly transitionable between a first state and a second state.

[0045] In some implementations, the first state is an extended state in which the proximal marker and the distal marker are fluoroscopically distinguishable from each other.

[0046] In some implementations, the second state is a compressed state in which the proximal marker and the distal marker are fluoroscopically indistinguishable from each other.

[0047] In some implementations, the indicator comprises a piezoelectric inclusion. In some implementations, the driver is adapted to drive the tissue-engaging element into the tissue until the piezoelectric inclusion presses against a surface of the tissue. In some implementations, the piezoelectric inclusion configured to generate piezoelectricity responsively to the pressing against the tissue.

[0048] In some implementations, the driver comprises a handle at a proximal part of the driver. In some implementations, the driver comprises a shaft extending distally from the handle. In some implementations, the rod extends from the handle distally through the shaft (e.g., through a portion of the shaft or through the entire shaft).

[0049] In some implementations, a sensor is positioned at a proximal part of the driver. In some implementations, the sensor is adapted to sense movement of the rod with respect to the handle. In some implementations, the driver is adapted to transluminally deliver the anchor to the tissue and drive the tissue-engaging element into the tissue such that the tissue pushes the rod proximally with respect to the head and the handle.

[0050] In some implementations, the driver comprises a radiopaque portion, adapted to provide an indication of anchoring strength of the tissue-engaging element within the tissue, by, responsively to a proximal force applied to the driver, stretching axially by a predetermined amount.

[0051] In accordance with some implementations, a method includes transluminally delivering an anchor to a real or simulated tissue of a real or simulated subject, the anchor having a head and a tissue-engaging element. In some implementations, the tissue-engaging element extends away from the head to define an anchor axis of the anchor. In some implementations, the anchor includes an imaging marker or indicator (the same as or similar to any imaging markers or indicators herein) coupled to the head.

[0052] In some implementations, driving the tissue-engaging element into the real or simulated tissue such that the imaging marker or indicator moves with respect to the head.

[0053] In some implementations, observing, via an imaging modality, that the imaging marker has moved with respect to the head.

[0054] In some implementations, responsively to the step of observing, determining that the head is submerged in the real or simulated tissue.

[0055] In some implementations, the imaging marker or indicator is or comprises a disk. In some implementations, driving the tissue-engaging element into the tissue includes driving the tissue-engaging element into the tissue while the disk extends around tissue-engaging element. In some implementations, this is done such that as the tissue-engaging element is driven into tissue, the disk gets progressively closer to the head.

[0056] In some implementations, observing that the imaging marker has moved with respect to the head includes observing contact between the head and the disk.

[0057] In some implementations, observing that the imaging marker has moved with respect to the head includes observing that the disk cups around the head.

[0058] In some implementations, determining that the head is submerged in the tissue includes determining that the head is submerged in the tissue, responsively to observing that the disk cups around the head.

[0059] In accordance with some implementations, a method includes transluminally delivering an anchor to a real or simulated tissue of a real or simulated subject. In some implementations, the anchor has a head. In some implementations, the anchor has a tissueengaging element. In some implementations, the tissue-engaging element extends away from the head to define an anchor axis of the anchor. In some implementations, the anchor includes an imaging marker or indicator (same as or similar to any of the imaging markers or indicators herein) coupled to the head.

[0060] In some implementations, screwing the tissue-engaging element into the real or simulated tissue such that the imaging marker or indicator moves with respect to the head.

[0061] In some implementations, observing, via an imaging modality, that the imaging marker has moved with respect to the head.

[0062] In some implementations, responsively to the step of observing, partially unscrewing the tissue-engaging element from the real or simulated tissue.

[0063] In accordance with some implementations, a method includes using a driver to transluminally deliver an anchor to a real or simulated tissue of a real or simulated subject. In some implementations, the driver includes one, some, or all of a handle, a shaft, and / or a drivehead or other engagement means. In some implementations, the driver is used to transluminally delivery the anchor while a head of the anchor is reversibly engaged by the drivehead or other engagement means. In some implementations, a rod extends, from the handle, distally through the shaft and the head.

[0064] In some implementations, driving a tissue-engaging element of the anchor into the real or simulated tissue such that the tissue pushes the rod proximally with respect to the head and the handle.

[0065] In some implementations, responsively to movement of the rod proximally with respect to the handle, identifying a depth to which the tissue-engaging element is anchored within the real or simulated tissue.

[0066] In some implementations, identifying the depth to which the tissue-engaging element is anchored within the tissue includes identifying the depth to which the tissue-engaging element is anchored within the tissue responsively to imaging the movement of the rod with respect to the head.

[0067] In some implementations, the method further includes, subsequently to driving the tissue-engaging element into the tissue, disengaging the driver from the anchor, by pulling the rod proximally.

[0068] In some implementations, the anchor is reversibly engaged by the drivehead or other engagement means, and the rod extends, from the handle, distally through the shaft while a second rod extends, from the handle, distally to engage with the head.

[0069] In some implementations, the tissue-engaging element is a helical tissue-engaging element that defines a helix, and the rod extends within helix.

[0070] In accordance with some implementations, a system (e.g., usable and / or for use at a tissue site of a subject (e.g., a living subject, a simulation, etc.)) includes an anchor. In some implementations, the anchor defines a head. In some implementations, the anchor defines a tissue-engaging element. In some implementations, the tissue-engaging element extends away from the head to define an anchor axis of the anchor.

[0071] In some implementations, the system includes a driver. In some implementations, the driver includes a handle at a proximal part of the driver. In some implementations, the driver includes a shaft extending distally from the handle.

[0072] In some implementations, the driver includes a rod extending from the handle, distally through the shaft.

[0073] In some implementations, the driver includes a sensor, at the proximal part of the driver, adapted to sense movement of the rod with respect to the handle.

[0074] In some implementations, the driver includes a drivehead or other engagement means coupled to the shaft at a distal part of the driver. In some implementation, the drivehead or other engagement means is configured to engage the head whereby the rod extends distally through the head.

[0075] In some implementations, the driver is adapted to transluminally deliver the anchor to the tissue while the head is engaged by the drivehead or other engagement means.

[0076] In some implementations, the driver is adapted to drive the tissue-engaging element into the tissue such that the tissue pushes the rod proximally with respect to the head and the handle.

[0077] In some implementations, the driver includes an indicator, operatively coupled to the sensor so as to provide an indication, signal, or read-out responsively to the sensor sensing the pushing of the rod proximally with respect to the handle.

[0078] In some implementations, the indication, signal, or read-out is electronic. In some implementations, the indication, signal, or read-out is mechanical.

[0079] In some implementations, the indication, signal, or read-out is binary. In some implementations, the indication, signal, or read-out is continuous.

[0080] In some implementations, the tissue-engaging element is a helical tissue-engaging element that defines a helix, and the rod extends within helix.

[0081] In some implementations, the indicator is adapted to provide a continuum of indications as the rod moves proximally with respect to the handle.

[0082] In some implementations, the shaft is adapted to transfer an anchoring force, from the handle to the anchor in order to drive the tissue-engaging element into the tissue.

[0083] In some implementations, the indicator is mounted on the handle.

[0084] In accordance with some implementations, a method includes using a driver that includes a handle and a shaft. In some implementations, the driver includes a drivehead or other coupling or engagement means, e.g., clamp, screwdriver interface, friction fit, geared interaction, etc. In some implementations, the driver can be used to transluminally deliver an anchor to a real or simulated tissue of a real or simulated subject while a head of the anchor is reversibly engaged with the driver (e.g., via a drivehead, etc.). In some implementations, the driver includes a radiopaque portion that stretches responsively to being pulled proximally away relative to the anchor or tissue.

[0085] In some implementations, the method includes driving a tissue-engaging element of the anchor into the real or simulated tissue.

[0086] In some implementations, the method includes subsequently pulling the driver proximally. This can be done, for example, while the driver remains engaged with the head, e.g., via a drive head or other engagement means.

[0087] In some implementations, the method includes imaging the radiopaque portion.

[0088] In some implementations, the method includes, responsively to the imaging, determining that the anchor is satisfactorily anchored to the real or simulated tissue.

[0089] In some implementations, the driver further includes an outer tube that extends coaxially around the shaft, the outer tube being attached to the drivehead, and defining the radiopaque portion,

[0090] In some implementations, using the driver to transluminally deliver the anchor to the tissue includes using the driver that includes the outer tube to transluminally deliver the anchor to the tissue.

[0091] In some implementations, the radiopaque portion is disposed at a distal part of the driver.

[0092] In some implementations, the radiopaque portion is formed by cutting slits along a distal part of the driver.

[0093] In some implementations, the radiopaque portion is a spring.

[0094] In some implementations, imaging the radiopaque portion includes fluoroscopically imaging the radiopaque portion.

[0095] In some implementations, imaging the radiopaque portion includes imaging the radiopaque portion while the radiopaque portion is disposed within a thorax of the subject.

[0096] In some implementations, the tissue is tissue of a heart of the subject. In some implementations, imaging the radiopaque portion includes imaging the radiopaque portion while the radiopaque portion is disposed within the heart.

[0097] In accordance with some implementations, a system (e.g., usable and / or for use with a tissue anchor, etc.) includes an anchor defining a head and a tissue-engaging element. In some implementations, the tissue-engaging element extends away from the head to define an anchor axis of the anchor.

[0098] In some implementations, the driver includes a handle. In some implementations, the driver includes a shaft.

[0099] In some implementations, the driver includes a drivehead, the driver adapted to anchor the tissue-engaging element into tissue of a subject (e.g., a living subject, a simulation, etc.) while the head is reversibly engaged by the drivehead. Other coupling or engagement means between the driver and anchor are possible, such as a clamp, screwdriver interface, friction fit, geared connection, etc.

[0100] In some implementations, the driver includes a radiopaque portion, adapted to provide an indication of anchoring strength of the tissue-engaging element within the tissue, by, responsively to a proximal force applied to the driver, stretching axially by a predetermined amount. This can be done while the anchor is engaged with the driver, e.g., via a drivehead or other coupling or engagement means, such as a clamp, screwdriver interface, friction fit, etc.

[0101] In some implementations, the radiopaque portion is a zone on the driver that has reduced tensile strength.

[0102] In some implementations the radiopaque portion has a diameter, and / or (ii) the radiopaque portion is adapted to, responsively to the proximal force, stretch axially while substantially retaining the diameter.

[0103] In some implementations, the driver further includes an outer tube that extends coaxially around the shaft, the outer tube being attached to the drivehead, and defining the radiopaque portion.

[0104] In some implementations, the radiopaque portion is adapted to, responsively to a proximal force applied to the outer tube, stretch axially by the predetermined amount.

[0105] In some implementations, the radiopaque portion defines multiple slits along a distal part of the driver.

[0106] In some implementations, the radiopaque portion is a spring.

[0107] In some implementations, the radiopaque portion is disposed at a distal part of the driver.

[0108] In some implementations, the radiopaque portion is disposed within 10cm of the drivehead.

[0109] In accordance with some implementations, a system (e.g., usable and / or for use at a heart of a subject (e.g., a living subject, a simulation, etc.)) includes an anchor. In some implementations, the anchor includes a tissue-engaging element.

[0110] In some implementations, the anchor includes a head. In some implementations, the head includes an indicator. In some implementations, the head and / or indicator comprises a piezoelectric inclusion.[OHl] In some implementations, the system includes a driver. In some implementations, the driver includes a handle at a proximal part of the driver. In some implementations, the driver includes a shaft extending distally from the handle.

[0112] In some implementations, the driver includes a drivehead coupled to the shaft at a distal part of the driver.

[0113] In some implementations, the driver is adapted to, e.g., via engagement of the head by the drivehead or other engagement means, drive the tissue-engaging element into tissue of the heart until the head presses against a surface of the tissue. In some implementations, the piezoelectric inclusion is configured to generate piezoelectricity responsively to the pressing of the head against the tissue.

[0114] In some implementations, the driver is adapted to conduct the piezoelectricity from the head to the proximal part of the driver.

[0115] In some implementations, the head includes an interface configured to be engaged by the drivehead. In some implementations, in some implementations the anchor and / or head includes a disk. In some implementations, the disk is part of an indicator. In some implementations, the indicator and / or disk includes the piezoelectric inclusion. In some implementations, the disk is positioned with respect to the interface such that the disk becomes pressed against the tissue responsively to anchoring of the anchor into the tissue.

[0116] In some implementations, the disk includes the piezoelectric inclusion. In some implementations, the disk is positioned with respect to the interface such that the disk becomes pressed against a component or a series of components that are pressed against the tissue responsively to the anchoring of the anchor into the tissue.

[0117] In some implementations, the piezoelectric inclusion is a piezoelectric yarn, woven into the disk.

[0118] In some implementations, the disk can comprise and / or be formed from a piezoelectric textile.

[0119] In some implementations, the disk includes one or more of Polyethylene terephthalate (PET), polymer polyvinylidene fluoride (PVDF), aluminum nitride, BariumTitanate, Lithium tantalate, potassium sodium tartrate, potassium niobate, and polypeptide poly(benzyl glutamate) (PBLG).

[0120] In some implementations, the head defines a body. In some implementations, the body defines the interface.

[0121] In some implementations, the disk is attached to a tissue-facing surface of the body.

[0122] In some implementations, the disk is threaded onto the tissue-engaging element in a manner in which driving the tissue-engaging element into the tissue causes the disk to get progressively closer to the interface by the disk remaining at a surface of the tissue.

[0123] In some implementations, the piezoelectric inclusion is a first piezoelectric inclusion. In some implementations, an inner region of the disk includes the first piezoelectric inclusion.

[0124] In some implementations, the disk further includes a second piezoelectric inclusion. In some implementations, an outer region of the disk includes the second piezoelectric inclusion.

[0125] In some implementations, the disk is positioned with respect to the interface such that the inner region of the disk becomes pressed between a tissue-facing surface of the head and the tissue responsively to anchoring of the anchor into the tissue. In some implementations, the outer region of the disk does not become pressed by the tissue-facing surface.

[0126] In some implementations, the first piezoelectric inclusion is electrically isolated from the second piezoelectric inclusion.

[0127] In some implementations, the disk defines a band in between the inner region and the outer region, the band comprised of a non -piezoelectric material.

[0128] In some implementations, the system includes a sensor, adapted to sense the conducted piezoelectricity.

[0129] In some implementations, the piezoelectric inclusion is a piezoelectric crystal.

[0130] In some implementations, the piezoelectric inclusion includes a ceramic material.

[0131] In some implementations, the sensor is configured to, responsively to the sensed piezoelectricity, provide an indication of contact between the head and the tissue surface.

[0132] In some implementations, the piezoelectric inclusion is disposed at a tissue-facing surface of the head. In some implementations, the driver is adapted to drive the tissueengaging element into the tissue such that the piezoelectric inclusion becomes pressed against a surface of the tissue without penetrating the tissue.

[0133] In some implementations, the head can comprise and / or be formed from a piezoelectrically conductive material, and the sensor is adapted to sense the conducted piezoelectricity via the head.

[0134] In some implementations, the driver is disengageable from the head within the heart.

[0135] In some implementations, the shaft is adapted to conduct piezoelectricity. In some implementations, the sensor is adapted to sense the conducted piezoelectricity via the shaft.

[0136] In some implementations, the driver further includes a rod, extending through the shaft to the drivehead. In some implementations, the rod is configured to control engagement of the drivehead with the head. In some implementations, the rod is adapted to conduct piezoelectricity.

[0137] In some implementations, the sensor is adapted to sense the conducted piezoelectricity via the rod.

[0138] In some implementations, the driver further includes a connector. In some implementations, the connector can extend through the shaft, e.g., optionally to the drivehead. In some implementations, the connector is adapted to conduct piezoelectricity.

[0139] In some implementations, the sensor is adapted to sense the conducted piezoelectricity via the connector.

[0140] In some implementations, the connector is a wire.

[0141] In some implementations, the system further includes a processor. In some implementations, the processor is electrically connected to the sensor. In some implementations, the processor is adapted to provide, responsively to the sensed piezoelectricity, an indication of contact between the head and the tissue surface.

[0142] In some implementations, the anchor is disconnectable from the processor subsequently to driving the tissue-engaging element into the tissue, by disengaging the driver from the head.

[0143] In some implementations, the processor is adapted to provide an indication of current or voltage of the piezoelectricity sensed by the sensor.

[0144] In some implementations, the processor is adapted to provide a stop signal upon an electrical indication such as current or voltage of the piezoelectricity exceeding a predetermined threshold, the stop signal being an indication of anchoring-completeness.

[0145] In some implementations, the anchor further includes a disk that includes the piezoelectric inclusion. In some implementations, the disk is positioned with respect to the head such that an inner region of the disk becomes pressed between a tissue-facing surface of the head and the tissue responsively to anchoring of the anchor into the tissue. In some implementations, an outer region of the disk does not become pressed by the tissue-facing surface.

[0146] In some implementations, the processor is adapted to provide the indication of contact between the head and the tissue surface upon detecting a piezoelectric signal from the inner region. In some implementations, the processor is adapted to indicate overanchoring upon detecting a piezoelectric signal from the outer region.

[0147] In some implementations, the inner region and the outer region are electrically isolated from each other.

[0148] In some implementations, a first connector connects the inner region to the processor, and a second connector connects the outer region to the processor, the first connector and the second connector being electrically isolated from each other.

[0149] In some implementations, the processor is adapted to provide the indication of contact between the head and the tissue surface upon detecting a piezoelectric signal from both the inner region and the outer region.

[0150] In accordance with some implementations, a system useable and / or for use at a tissue of a heart includes an anchor defining a head and a tissue-engaging element extending away from the head. In some implementations, the tissue-engaging element extends away from the head such that it defines an anchor axis of the anchor.

[0151] In some implementations, the system also includes a driver. In some implementations, the driver includes a shaft. In some implementations, the driver includes a drivehead, which can be at a distal end of the shaft. In some implementations, the driver adapted to anchor the tissue-engaging element into tissue of the heart. In someimplementations, this can be done while the drivehead is engaged with the head of the anchor.

[0152] In some implementations, the system also includes a catheter. In some implementations, the driver is adapted to transluminally deliver the anchor via the catheter to the heart. In some implementations, the catheter has a distal portion that includes one, some, or all of: a radiopaque proximal marker, a radiopaque distal marker, and / or a compressible zone. In some implementations, the compressible zone couples the proximal marker to the distal marker.

[0153] In some implementations, the catheter is arranged or configured such that, via application and release of an axially-compressive force to the distal portion, the distal portion is reversibly transitionable between: (i) an extended state in which the proximal marker and the distal marker are fluoroscopically distinguishable from each other, and / or (ii) a compressed state in which the proximal marker and the distal marker are fluoroscopically indistinguishable from each other.

[0154] In some implementations, the distal portion is biased to be in the extended state.

[0155] In some implementations, the distal marker and the proximal marker are markers of a series of markers, the series of markers being axially positioned along the distal portion and interspaced with compressible zones.

[0156] In some implementations, in the extended state of the distal portion, the compressible zone spaces the proximal marker and the distal marker away from each other. In some implementations, in the compressed state of the distal portion, the proximal marker contacts the distal marker.

[0157] In some implementations, in the compressed state of the distal portion, the proximal marker is aligned with the distal marker.

[0158] In some implementations, in the compressed state of the distal portion, the proximal marker is coaxial with the distal marker.

[0159] In some implementations, the compressible zone is adapted to collapse responsively to the axially-compressive force in a manner in which the proximal marker nests within the distal marker.

[0160] In some implementations, the compressible zone is adapted to buckle inwardly responsively to the axially-compressive force.

[0161] In some implementations, the compressible zone is less rigid than a more proximal part of the catheter, such that the compressible zone collapses responsively to the axially - compressive force.

[0162] In some implementations, the compressible zone is defined by interconnected struts, the struts adapted to deform responsively to the axially -compressive force.

[0163] In some implementations, the compressible zone is stent-like, the compressible zone is adapted to compress responsively to the axially-compressive force by foreshortening.

[0164] In some implementations, the compressible zone is braided, the distal portion transitionable to the compressed state responsively to the axially-compressive force by the braid becoming compressed.

[0165] In some implementations, the head of the anchor defines a radiopaque anchormarker.

[0166] In some implementations, while the distal portion is in the compressed state, the driver is adapted to anchor the tissue-engaging element to the tissue until the anchor-marker becomes fluoroscopically indistinguishable from the proximal and distal markers.

[0167] In some implementations, the distal portion is biased to be in the extended state. In some implementations, when the distal portion is in the compressed state by being pressed against the tissue, the catheter is releasable such that the distal portion reverts to extended state.

[0168] In some implementations, the compressible zone is sufficiently weak such that, if the tissue-engaging element is well-anchored to the tissue, using the driver to pull the anchor proximally while the anchor remains anchored to the tissue transitions the distal portion to its compressed state by the tissue exerting a proximally-directed force against the distal portion.

[0169] In accordance with some implementations, a method useable or for use with tissue of a heart (or other part of a body) includes transluminally advancing a catheter towards the heart. In some implementations, the catheter has a distal portion that includes a radiopaque proximal marker. In some implementations, the catheter has a distal portion that includes a radiopaque distal marker. In some implementations, the catheter includes a compressible zone. In some implementations, the compressible zone couples the proximal marker to the distal marker.

[0170] In some implementations, the method includes fluoroscopically identifying the proximal marker and the distal marker within the heart. In some implementations, the method includes, subsequently, pressing the distal portion against the tissue such that the compressible zone compresses, and the proximal marker and the distal marker become fluoroscopically indistinguishable from each other.

[0171] In some implementations, while the proximal marker and the distal marker remain fluoroscopically indistinguishable from each other, the method includes driving a tissueengaging element of an anchor out of the distal portion and into the tissue.

[0172] In some implementations, while the proximal marker and the distal marker remain fluoroscopically indistinguishable from each other, the method includes determining (i) successful anchoring of the tissue-engaging element in the tissue by determining that a head of the anchor has become fluoroscopically indistinguishable from the proximal marker and the distal marker, versus (ii) unsuccessful anchoring of the tissue-engaging element in the tissue by determining that the head of the anchor remains fluoroscopically distinguishable from the proximal marker and the distal marker.

[0173] In some implementations, the distal marker and the proximal marker are markers of a series of markers positioned along the distal portion. In some implementations, the compressible zone is a compressible zone of a series of compressible zones. In some implementations, each marker is axially spaced from its neighboring marker by a respective compressible zone. In some implementations, pressing the distal portion against the tissue includes pressing the distal portion against the tissue such that the compressible zones compress, and the series of markers become fluoroscopically indistinguishable from each other.

[0174] In some implementations, pressing the distal portion against the tissue includes pressing the distal portion against the tissue such that the proximal marker moves distally towards the distal marker.

[0175] In some implementations, pressing the distal portion against the tissue includes pressing the distal portion against the tissue such that the proximal marker becomes aligned with the distal marker.

[0176] In some implementations, pressing the distal portion against the tissue includes pressing the distal portion against the tissue such that the proximal marker becomes coaxial with the distal marker.

[0177] In some implementations, pressing the distal portion against the tissue includes pressing the distal portion against the tissue such that compressible zone collapses in a manner in which the proximal marker nests within the distal marker.

[0178] In some implementations, pressing the distal portion against the tissue includes pressing the distal portion against the tissue such that the compressible zone buckles inwardly.

[0179] In some implementations, the head of the anchor defines a radiopaque anchor-marker and determining successful anchoring of the tissue-engaging element in the tissue by determining that the head of the anchor has become fluoroscopically indistinguishable from the proximal marker and the distal marker includes determining that the anchor-marker has become fluoroscopically indistinguishable from the proximal marker and the distal marker.

[0180] In some implementations, determining successful anchoring of the tissue-engaging element in the tissue further includes pulling the anchor proximally to determine that (i) the proximal marker, the distal marker, and the anchor -marker all remain fluoroscopically indistinguishable, versus (ii) the anchor-marker becomes fluoroscopically distinguishable from the proximal and distal markers.

[0181] In some implementations, determining successful anchoring of the tissue-engaging element by pulling the anchor proximally includes pulling the anchor proximally such that: (a) the anchor-marker transiently becomes fluoroscopically distinguishable from the proximal marker and the distal marker, and / or (b) the anchor-marker returns to being fluoroscopically indistinguishable from the proximal marker and the distal marker.

[0182] In some implementations, determining successful anchoring of the tissue-engaging element further includes, subsequently to anchoring the anchor into the tissue: (a) releasing the catheter such that the proximal marker and the distal marker become fluoroscopically distinguishable from each other, and / or (b) while fluoroscopically imaging the distal portion, pulling the anchor proximally to determine whether the proximal marker and the distal marker become fluoroscopically indistinguishable.

[0183] In some implementations, the compressible zone is biased to be in an extended state in which the proximal marker and the distal marker are fluoroscopically distinguishable, and releasing the catheter includes releasing the catheter such that the catheter reverts automatically to its extended state.

[0184] In some implementations, the distal marker and the proximal marker are markers of a series of markers. In some implementations, the compressible zone is a compressible zone of a series of compressible zones. In some implementations, each marker is axially spaced from its neighboring marker by a respective compressible zone. In some implementations, releasing the catheter includes releasing the catheter such that the series of markers become fluoroscopically distinguishable from each other.

[0185] In some implementations, determining successful anchoring of the tissue-engaging element in the tissue by pulling the anchor proximally includes determining successful anchoring of the tissue-engaging element in the tissue by pulling the anchor proximally to determine the number of markers of the series that become fluoroscopically indistinguishable from each other.

[0186] In accordance with some implementations, a catheter (e.g., usable and / or for use at a tissue of a subject, such as a living subject or simulation) has a distal portion. In some implementations, the distal portion comprises a radiopaque proximal marker. In some implementations, the distal portion comprises a radiopaque distal marker.

[0187] In some implementations, the distal portion comprises a compressible zone between the proximal marker and the distal marker. In some implementations, the catheter is configured such that, via application and release of an axially-compressive force to the distal portion, the distal portion is reversibly transitionable between a first state and a second state.

[0188] In some implementations, the first state is an extended state in which the proximal marker and the distal marker are fluoroscopically distinguishable from each other.

[0189] In some implementations, the second state is a compressed state in which the proximal marker and the distal marker are fluoroscopically indistinguishable from each other.

[0190] In some implementations, the distal portion is biased to be in the extended state.

[0191] In some implementations, the distal marker and the proximal marker are markers of a series of markers. In some implementations, the series of markers are axially positioned along the distal portion and interspaced with compressible zones.

[0192] In some implementations, in the extended state of the distal portion, the compressible zone spaces the proximal marker and the distal marker away from each other. In someimplementations, in the compressed state of the distal portion, the proximal marker contacts the distal marker.

[0193] In some implementations, in the compressed state of the distal portion, the proximal marker is aligned with the distal marker.

[0194] In some implementations, in the compressed state of the distal portion, the proximal marker is coaxial with the distal marker.

[0195] In some implementations, the compressible zone is adapted to collapse responsively to the axially-compressive force in a manner in which the proximal marker nests within the distal marker.

[0196] In some implementations, the compressible zone is adapted to buckle inwardly responsively to the axially-compressive force.

[0197] In some implementations, the compressible zone is less rigid than a more proximal part of the catheter, such that the compressible zone collapses responsively to the axially- compressive force.

[0198] In some implementations, the compressible zone is defined by interconnected struts, the struts adapted to deform responsively to the axially-compressive force.

[0199] In some implementations, the compressible zone is stent-like, the compressible zone is adapted to compress responsively to the axially-compressive force by foreshortening.

[0200] In some implementations, the compressible zone is braided, the distal portion transitionable to the compressed state responsively to the axially-compressive force by the braid becoming compressed.

[0201] In some implementations, the distal portion is biased to be in the extended state, and wherein, when the distal portion is in the compressed state by being pressed against the tissue, the catheter is releasable such that the distal portion reverts to extended state.

[0202] In some implementations, the catheter is part of a system, the system comprising the catheter and an anchor. The anchor can be the same as or similar to any of the anchors described anywhere herein. In some implementations, the anchor defines a head, and a tissue-engaging element extending away from the head.

[0203] In some implementations, the system further includes a driver. The driver can be the same as or similar to any of the drivers disclosed anywhere herein. In some implementations,the driver comprises a shaft. In some implementations, the driver comprises a drivehead at a distal end of the shaft.

[0204] In some implementations, the driver is adapted or configured to anchor the tissueengaging element into tissue of the heart. In some implementations, this is done while the drivehead is engaged with the head.

[0205] In some implementations, the head of the anchor defines a radiopaque anchormarker. In some implementations, while the distal portion is in the compressed state, the driver is adapted to anchor the tissue-engaging element to the tissue until the anchor-marker becomes fluoroscopically indistinguishable from the proximal and distal markers.

[0206] In some implementations, the compressible zone is sufficiently weak such that using the driver to pull the anchor proximally while the anchor remains anchored to the tissue transitions the distal portion to its compressed state by the tissue exerting a proximally- directed force against the distal portion.

[0207] 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., simulated heart, simulated tissue, etc.) and can optionally comprise computerized and / or physical representations.

[0208] 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.).

[0209] The present invention will be more fully understood from the following detailed description of implementations thereof, taken together with the drawings, in which:BRIEF DESCRIPTION OF THE DRAWINGS

[0210] Figs. 1A-C, 2A-C, 3A-D, 4A-C, 5A-C, 6A-C, 7A-C, 8A-C, 9A-C, 10A-C, 11A-C, 12A-C, and 13 are schematic illustrations showing various example tissue anchors, in accordance with some implementations; and

[0211] Figs. 14A-B, 15A-D, 16A-B, 17A-C, 18A-D, and 19-21 are schematic illustrations showing various anchoring systems that are adapted to provide feedback regarding the depth and / or the anchoring strength of an anchor within the heart, in accordance with some implementations.DETAILED DESCRIPTION OF EMBODIMENTS

[0212] During anchoring of an anchor into tissue of a subject (e.g., a living subject, a simulation, etc.) (e.g., into tissue of a heart of the subject), it may be desirable to determine the depth of the anchor within the tissue. For example, the anchor can comprise an anchor head, and a tissue-engaging element that is adapted to penetrate, and become anchored (e.g., submerged) within the tissue. In some implementations, the tissue-engaging element can be a helical tissue-engaging element that is screwed into the tissue. It may be desirable to anchor the anchor into tissue such that the tissue-engaging element of the anchor becomes fully submerged within the tissue, and the head abuts (e.g., contacts, but does not penetrate) a surface of the tissue. Additionally or alternatively, in some implementations, it may be desired that the head become partially, but not fully, submerged within the tissue. In some implementations, it may be desired that the head become fully submerged within the tissue.

[0213] In some implementations, over-anchoring of the anchor into the tissue can damage the tissue, and reduce the anchoring-retention strength of the tissue. In some such implementations, if it has been determined that an anchor has been over-anchored within the tissue, the anchor can be retracted (e.g., unscrewed) slightly, such that the anchor achieves a satisfactory depth within the tissue. In some implementations, if it has been ascertained that the anchor has been overly -anchored within the tissue, the anchor can be completely retracted (e.g., unscrewed) from the tissue, and can subsequently be anchored elsewhere, as the tissue may have become damaged by the over-anchoring.

[0214] Systems, methods and techniques are therefore disclosed herein to aid in determining whether an anchor has been anchored satisfactorily into the tissue, and specifically, whether an anchor has been over-anchored (e.g., overtightened) within the tissue.

[0215] Reference is made to Figs. 1A-C, 2A-C, 3A-D, 4A-C, 5A-C, 6A-C, 7A-C, 8A-C, 9A-C, 10A-C, 11 A-C, and 12A-C which are schematic illustrations showing various anchors 120, in accordance with some implementations.

[0216] In some implementations, each of the anchors defining a head 122, and a tissueengaging element 124 extending away from the head to define an anchor axis axl of the anchor. Although tissue-engaging elements 124 illustrated herein are embodied as helical and / or a screw-in tissue-engaging elements, it is to be understood that any other type of tissue-engaging element, e.g., a dart, a staple, or a clip could similarly be used.

[0217] The anchors shown and / or described herein may be components of an implant, e.g., of an annuloplasty implant, a repair implant, or any other implant.

[0218] In some such implementations, the anchors are attached to a tether that tethers various components of the implant thereto, e.g., that tethers multiple anchors to each other. For example, head 122 of each of the anchors can define an eyelet, through which such a tether can be threaded.

[0219] In some implementations, any of the anchors 120, and / or delivery tools (e.g., drivers) used to deliver the anchors can be as described in one or more of the following references, mutatis mutandis, each of which is incorporated by reference in its entirety:US Patent Application Publication 2014 / 0309661 to Sheps et al.US Patent Application Publication 2015 / 0272734 to Sheps et al.US Patent Application Publication 2018 / 0049875 to Iflah et al.International Patent Application Publication WO 2024 / 121770 to Halabi et al.

[0220] In some implementations, an anchor driver (not shown) can be used to anchor any of the anchors into the tissue. For example, the driver can include a flexible shaft, and a drive head at a distal end of the shaft that is adapted to, for each anchor, reversibly engage the head. In some implementations, the driver is adapted to anchor each of the anchors into the tissue (e.g., adjacent a valve) by, for each anchor, applying an anchoring force to the anchor (e.g., by applying torque) to drive (e.g., to screw) tissue-engaging element 124 into the tissue e.g., until a tissue-facing surface 126 of head 122 abuts, but does not penetrate, the tissue. For simplicity, the driver is not shown in Figs. 1A-13.

[0221] Each of Figs. 1 A-13 comprises an indicator or imaging marker 130 that is adapted to move, or change conformation, responsively to the head 122 being inserted in the subject's tissue 5, during which imaging the anchor can indicate the anchor head's position with respect to the tissue. The imaging markers can be visible under X-ray, fluoroscopy, CT,MRI, ultrasound, and / or any other imaging modalities. The anchor (e.g., the imaging marker thereof) can be imaged continuously or iteratively with the anchoring.

[0222] In some of these figures, head 122, or a portion thereof, is also visible under imaging (e.g., the head is at least partially radiopaque).

[0223] In some such implementations, the respective position of the indicator or imaging marker 130 with respect to head 122 is used to assess the depth of the anchor within the tissue e.g., whether the anchor has been satisfactorily positioned within the tissue.

[0224] In some implementations, for any of the indicators or imaging markers 130 illustrated in Figs. 1A-C, 2A-C, 3A-D, 4A-C, 5A-C, 6A-C, 7A-C, 8A-C, 9A-C, 10A-C, 11A-C, and 12A-C, the indicator or imaging marker can provide an indication of the orientation and / or position of the anchor with respect to the tissue. For example, imaging marker 130 can be used to determine whether the anchor has been driven into the tissue at an undesirable angle (e.g., oblique with the tissue surface), rather than at an angle substantially perpendicular to the tissue (e.g., such that head 122 is generally parallel with the tissue). In some implementations, if imaging marker 130 is shown to be at an angle with respect to head 122 and / or anchor 120 more generally, then it may indicate that the anchor has been driven into the tissue at an undesirable angle, as explained in more detail in Fig. 13.

[0225] Figs. 1 A-C illustrate an anchor 120a defining head 122 and tissue-engaging element 124 extending away from the head to define anchor axis axl. Anchor 120a additionally comprises an indicator or imaging marker 130a, mounted to the head, and adapted to change position with respect to head 122 responsively to the anchor (e.g., tissue-engaging element thereof) being inserted in tissue 5.

[0226] In some implementations, indicator or imaging marker 130a comprises an imaging element 132 that is disposed on (e.g., threaded onto) a cord 134. Imaging element 132 can be a ball, a bead, and / or any other shape. In some implementations, cord 134 comprises a leaf spring, a tether, a string, a filament, and / or a suture.

[0227] In some implementations, the attachment between element 132 and head 122, e.g., via cord 134, allows for rotation and movement of element 132 with respect to the head. For example, in some implementations, as anchor 120a is anchored into the tissue, the imaging element can rotate around head 122, such that imaging of element 132 rotating therearound provides an indication that element 132 and / or cord 134 has not yet reached the tissue, e.g., as will be explained hereinbelow.

[0228] In some implementations, as tissue-engaging element 124 is screwed into tissue 5, element 132 is positioned distally to head 122 (Fig. 1A). As tissue-engaging element 124 becomes further anchored into the tissue, head 122 moves distally towards the tissue, becoming positioned parallel with element 132, e.g., as shown in Fig. IB. In some implementations, a state similar to the state shown in Fig. IB is desired for anchoring. For example, if it is determined, by imaging anchor 120a, that imaging element 132 is generally parallel to head 122 or an imaging marker mounted directly on the head, anchoring is ceased, and a driver used to anchor the anchor can be disengaged from the head and withdrawn from out of the subject, leaving the anchor anchored in the tissue.

[0229] If the anchor is driven into the tissue further, e.g., if over-anchoring occurs, head 122 can become submerged within tissue 5 (e.g., by tissue-engaging element 124 pulling the head therealong). In some such implementations, element 132 remains above tissue 5, e.g., the head becomes positioned distally to the imaging element (Fig. 1C). This change of position of the imaging element with respect to head 122 can provide a user with an indication of over-anchoring.

[0230] In some implementations, once anchor 120a is fully screwed into the tissue, imaging marker 130a may no longer be able to rotate around the head, due to cord 134 becoming stuck (e.g., sandwiched) between the tissue and the head, e.g., as shown in Fig. 1C. Thus, if, while imaging anchor 120a during anchoring, imaging marker 130a no longer rotates (e.g., orbits) head 122, then this may be an indication that head 122 has, or is becoming, submerged within the tissue.

[0231] Figs. 2A-C illustrate anchor 120b having an indicator or imaging marker 130b comprising an imaging pin 136 that protrudes distally beyond head 122 (Fig. 2A) prior to anchoring, such that upon head 122 abutting the surface of tissue 5 (Fig. 2B), the imaging pin is pushed proximally by the tissue. In some implementations, once tissue-engaging element 128 is optimally anchored within the tissue, pin 136 does not protrude proximally or distally with respect to head 122 (e.g., as shown in Fig. 2B). In some implementations, over-anchoring of anchor 120b can lead to pin 136 protruding proximally out of a proximal surface of head 122, e.g., as shown in Fig. 2C. It is to be understood that the movement of pin 136 can be progressive, e.g., the more imaging pin 136 juts out distally beyond head 122, the larger the indication that anchor 120b has not yet reached an optimal depth within the tissue, and the more pin 136 juts out proximally beyond the head, the larger the indication that the anchor has been over-anchored within the tissue. That is, some jutting out of the pineither proximally or distally may not signify an undesirably anchored anchor, rather the degree of protrusion may provide an indication of whether further anchoring / retraction of the anchor is required.

[0232] In some implementations, indicator or imaging marker 130b can comprise a spring 137 that compresses responsively to pin 136 moving proximally. Spring 137 may provide resistance that assists in the gradual, or progressive, proximal movement of pin 136 with respect to head 122 as anchor 120b is anchored into tissue 5.

[0233] Spring 137 may be visible under imaging. In some implementations, alternatively to or in addition to imaging pin 136 to determine the depth of. anchor 120b, the extent of compression of spring 137 is determined via imaging. In some such implementations, since the extent of compression of the spring is directly related to the depth of the anchor within the tissue, the spring's compression is used to assess the depth of the anchor within the tissue. In some such implementations, pin 136 need not be visible under imaging.

[0234] Pin 136 can have a rounded base 1361 that has a larger cross-section than a more proximal part, such that pin 136 is retained within head 122.

[0235] Figs. 3A-D illustrate anchor 120c having an indicator or imaging marker 130c mounted to head 122. In some implementations, imaging marker 130c comprises at least one imaging element 132c that is disposed on (e.g., threaded onto) a cord 134c. Imaging element(s) 132c can be a ball, a bead, and / or any other element. In some implementations, a pair of imaging elements 132c are disposed on either side (e.g., opposite sides) of cord 134c. In some implementations, cord 134c is a leaf spring, a wire, a tether, a string, a filament, a suture.

[0236] In some implementations, attachment between element 132c and head 122, e.g., via cord 134c, allows for rotation and movement of element 132c with respect to the head. For example, in some implementations, and as illustrated in Figs. 3A and B, as anchor 120c is anchored into the tissue, the imaging element may rotate (e.g., orbit) around head 122. In some implementations, once anchor 120c is fully screwed into the tissue, imaging marker 130c may no longer be able to rotate around the head, due to cord 134c becoming stuck (e.g., sandwiched) between the tissue and the head, e.g., as shown in Fig. 3D. That is, imaging element 132c rotating around head 122 provides an indication that the imaging element and / or cord 134c has not yet reached the tissue, since tissue-engaging element is not completely screwed into the tissue.

[0237] In some implementations, indicator or imaging marker 130c is disposed at, or in the vicinity of, a tissue-facing surface 126 of head 122, such that as soon as the head contacts tissue 5 (Fig, 3C), rotation of the imaging marker is impeded by the tissue, or by the sandwiching of the imaging marker between the head and the tissue, thereby providing an immediate indication of contact.

[0238] Figs. 4A-C, 5A-C, 6A-C, 7A-C, and 8A-C illustrate indicators or imaging markers 130d, 130e, 130f, 130g, 130h, 130i that comprise or are in the form of a flat disk, or sheet, such that anchoring the anchor into the tissue causes the disk to become wrapped around, or curled around, head 122.

[0239] Figs. 4A-C illustrate anchor 120d having an indicator or imaging marker 130d in the form of a flat disk (also referenced to with numeral 130d) or sheet that is positioned at the head's tissue-facing surface 126. Disk 130d can be formed from any material or fabric that is interwoven with a radiopaque wire or thread, such that the disk is at least partially radiopaque. Disk 130d can initially be flat, e.g., flush and parallel with tissue-facing surface 126 (Fig. 4A). Anchoring tissue-engaging element 124 into tissue 5 causes head 122 to progressively press, or squash, disk 130d between the head and the tissue surface, causing the disk to curve proximally around the anchor head (Fig. 4B). In some implementations, over-anchoring of anchor 120d into the tissue, e.g., such that head 122 becomes submerged within the tissue, causes the disk to become progressively more accumulated, curled, or wrapped-around, the head (Fig. 4C), such that the curvature of the disk is an indication of the extent of anchoring, or over-anchoring, of the anchor within the tissue.

[0240] Figs. 5A-C illustrate an anchor 120e having an indicator or imaging marker that is in the form of a disk 130e, e.g., a sheet of fabric. Disk 130e can be a variant of disk 130d, and additionally or alternatively to having a radiopaque wire or thread interwoven within the fabric, disk 130e can have a radiopaque wire 138 that is woven around a perimeter (e.g., circumference) of the disk (inset of Fig. 5A). Wire 138 can initially be parallel to tissuefacing surface 126 (Fig. 5A), but as the anchor is progressively anchored into the tissue, disk 130e may become pushed proximally away from the tissue (Fig. 5C), such that the disk curls around head 122. This may cause wire 138 to become positioned proximally to tissue-facing surface 126, e.g., as shown in Fig. 5C. In some implementations, during imaging, only wire 138 is visible with respect to head 122 (e.g., the fabric of disk 130e is not radiopaque), such that wire 138 is seen as a horizontal line that changes position with respect to head 122.

[0241] Figs. 6A-C illustrate some arrangements, or positions of a radiopaque wire 138 on disks 130f, 130g, 130h, in accordance with some implementations. Disks 130f, 130g, 130h can be variants, or behave in similar ways, to disk 130d and / or 130e described hereinabove.

[0242] Fig. 6A illustrates disk 130f having multiple radiopaque concentric circles mounted on the disk. In some such implementations, the concentric circles are formed from radiopaque wires 138f that are woven into a fabric or material sheet 139.

[0243] Fig. 6B illustrates disk 130g that can be identical to disk 130f, except that it defines an extension (e.g., protrusion) 1312 defining an eyelet 1315 through which a tether (not shown) can be threaded. In some such implementations, disk 130g can be tear-dropped shaped.

[0244] In some implementations, and as explained hereinabove, the anchors described herein are components of an implant (e.g., of an annuloplasty implant) that comprises multiple anchors. In some such implementations, a tether is threaded through the anchors to tether the anchors together, e.g., such that tensioning the tether draws the anchors together, thereby reducing a dimension of the tissue to which the anchors are anchored. For example, the tether can be threaded through eyelet(s) 1315. A perimeter of eyelet 1315 can be reinforced, e.g., in order to prevent the tether from tugging a hole in extension 1312 and becoming unfixed from the anchor.

[0245] Fig. 6C illustrates disk 130h having a radiopaque wire 138g that is woven in a spiral form along a material or fabric sheet 139.

[0246] Figs. 7A-C show anchor 120i having a bi-stable or multi-stable disk 130i that is transitionable between a first state in which the disk is cup-shaped and has a concavity 1305 that faces tissue 5 (Fig. 7A), and a second state in which the disk is cup-shaped and has a concavity 1305' that faces away from the tissue (Fig. 7C). Disk 130i can be a variant, or substantially identical to, disk 130f, e.g., having a radiopaque wire 138i woven along the disk such that the radiopaque wire defines concentric circles. These concentric circles may advantageously provide the support and / or structure for the bi-stability of the disk. Similarly, disk 130i can be a variant of, or substantively identical to disks 130g, 13 Oh, or any combination thereof.

[0247] In some implementations, as anchor 120i is advanced towards tissue 5 (e.g., via an anchor driver), disk 13 Oi is in the first state in which concavity 1305 points towards the tissue (Fig. 7A). In implementations in which disk 13 Oi defines concentric circles (e.g., radiopaquewires, etc.) that provide the structure for the bi-stability of the disk, imaging anchor 120i in this state may show a series (e.g., two) parallel horizontal lines, positioned distally to head 122 (Fig. 7A). Once tissue-engaging element 124 has been fully screwed into tissue 5 (Fig. 7B), head 122 contacts the tissue, and disk 130i becomes sandwiched between the tissue surface and head 122. In some such implementations, disk 130i may transition towards a flattened state in which the disk lies flat against the tissue (e.g., is pressed against the tissue surface).

[0248] In some implementations, disk 130i can be a tri-stable disk, e.g., the flattened state can be a third state in which the disk is stable.

[0249] In some implementations, this flattened state is temporary, e.g., it occurs as the disk is transitioning between the first and the second state.

[0250] Imaging the anchor while the disk is in this flattened state (e.g., during the transition between the first and the second states) may show a single horizontal line (e.g., overlapping with the tissue-facing surface of head 122). Further anchoring (e.g., screwing in) of anchor 120i results in disk 13 Oi transitioning towards the second state in which the disk "pops" back into a cup-shaped configuration, with the concavity 1305 of the cup facing away from the tissue surface (Fig. 7C). This may occur if head 122 becomes submerged, or is overly pressed against the tissue, thereby indicating that the anchor is sufficiently anchored, or overanchored, within the tissue.

[0251] Figs. 8A-C illustrate anchor 120j comprising a disk 130j, which may be considered to be a variant of disk 13 Oi. Disk 130j can similarly be a bistable disk transitionable between a first state (Fig. 8A) in which a concavity of the disk faces the tissue, and a second state (Fig. 8C) in which a concavity of the disk faces away from the tissue. However, rather than the support and / or structure of the bi-stability of the disk being provided by concentric circles of radiopaque wires, disk 130j has a radiopaque struts 138j that extend radially across the disk, e.g., as shown.

[0252] Figs. 9A-C illustrate anchor 120k comprising an imaging element (e.g., a disk 130k) that begins the anchoring process while being located distally to head 122 of the anchor (Fig. 9A), e.g., against the tissue surface. Disk 130k can be a variant of any of the disks described herein, e.g., it can comprise radiopaque materials and / or wires that serve as an imaging marker during anchoring of anchor 120k.

[0253] In some implementations, disk 130k can be threaded onto tissue-engaging element 124 of the anchor, such that as the tissue-engaging element becomes progressively screwed into the tissue, disk 130k remains positioned against the tissue surface and becomes positioned progressively closer to head 122. Once tissue-engaging element has been fully screwed into the tissue (Fig. 9B), tissue-facing surface 126 of head 122 becomes positioned against disk 130k, e.g., such that the head rests against the disk.

[0254] In some implementations, imaging anchor 120k in this state can show disk 130k substantially flat, with head 122 positioned just proximally to the disk. Further anchoring of anchor 120k into the tissue may result in disk 130k curving proximally, e.g., as head 122 sinks into the tissue, it may cause the disk to curve around the head (Fig. 9C). Imaging anchor 120k in this state may show a curved or concave disk.

[0255] Figs. 10A-C illustrate an anchor 1201 having a disk 1301 that has two radiopaque layers 133 and 135 that are separated by a compressible layer 131 (e.g., having a honeycomb or herringbone structure), such that during anchoring of the anchor into the tissue, layer 131 becomes progressively compressed, causing radiopaque layers 133 and 135 to move progressively closer towards each other. Disk 1301 may be positioned in a similar manner to disk 130d or disk 130k prior to anchoring, e.g., against a tissue-facing surface 126 of the head 122 of the anchor, or threaded onto the tissue-engaging element 124 of the anchor.

[0256] In some implementations, layer 131 is not radiopaque. In some such implementations, layer 131 is constructed from a fabric, such as from a knitted fabric, or a yarn, such as a mono polyester yam and / or a textured yarn.

[0257] In some implementations, layer 131 has a thickness of at least 5mm, e.g., at least 7mm. In some implementations, layers 131, 133, and 135 are formed from the same material, but layers 133 and 135 are additionally woven or knitted with a radiopaque wire or thread, rendering them radiopaque.

[0258] In accordance with some implementations, Fig. 10A shows disk 1301 in a noncompressed state in which layer 131 separates layers 133 and 135 therefrom, prior to anchoring of tissue-engaging element 124 into tissue 5. Imaging anchor 1201 in this state may show disk 1301 as two discrete, separate horizontal lines, e.g., layers 133 and 135 spaced apart from each other. As tissue-engaging element 124 becomes progressively screwed into the tissue (Fig. 10B), head 122 begins to press disk 1301 against tissue 5, thereby compressing disk 1301 (e.g., layer 131 thereof). In some such implementations, a centralportion of disk 1301 may be compressed more than the peripheral parts of the disk. For example, as the head progressively presses against disk 1301, layer 133 may become progressively more concave (e.g., with layer 135 remining essentially flat), e.g., as shown in Figs. 10B and 10C. Imaging disk 1301 in this state may show layers 133 and 135 having moved closer towards each other, e.g., due to the compression of layer 131 therebetween.

[0259] In some implementations, anchor 1201 is anchored into the tissue until a predetermined distance between layers 133 and 135 is achieved. That is, having a gap smaller than the predetermined distance may indicate that anchor 1201 has become overly anchored (e.g., overly submerged) within the tissue. Similarly, having a gap significantly larger than the predetermined distance may indicate that the anchor is not anchored sufficiently in the tissue, and that further anchoring is required.

[0260] In some implementations, anchor 1201 may be anchored into the tissue until a predetermined concaveness of layer 133 has been achieved. In some such implementations, over-anchoring of anchor 1201 into the tissue, e.g., such that head 122 becomes submerged within the tissue, may also cause disk to curve around head 122 (Fig. 10C), as described with reference to other disks hereinabove.

[0261] Figs. 11A-C illustrate an anchor 120m having a radiopaque balloon 130m mounted on head 122 at a tissue-facing surface 126 thereof. In some implementations, and as shown in Figs 11A-B, as tissue-engaging element 124 is anchored into the tissue, the balloon becomes sandwiched between head 122 (e.g., tissue-facing surface 126 thereof), and the tissue surface. This sandwiching causes balloon 130m to become compressed and to deform, such that imaging the balloon during anchoring provides an indication of the position (e.g., the depth and / or orientation) of the anchor within the tissue.

[0262] In some implementations, the material from which balloon 130m is formed is itself radiopaque. In some implementations, balloon 130m can contain a radiopaque substance (e.g. a liquid, a paste, or a gel).

[0263] In some implementations, balloon 130m is a compliant balloon. In some implementations, balloon 130m is a non-compliant balloon.

[0264] Fig. 11A illustrates anchor 120m partially anchored within tissue 5, but with head 122 not yet abutting the tissue surface. At this stage, balloon 130m is at least partially rounded, e.g., the balloon can be a semi-sphere that faces distally towards the tissue. As the anchor becomes further anchored into the tissue, balloon 130m can assume a flattened orsubstantially linear state (Fig. 1 IB), e.g., due to the balloon becoming sandwiched between head 122 and the tissue surface. During imaging of anchor 120m, observing that balloon 130m is in this flattened state in which it lies parallel to the tissue may indicate that the anchor has been anchored to a required depth within the tissue, and that anchoring has been achieved. Further anchoring of anchor 120m into tissue 5 may cause balloon 130m to bulge around head 122 (Fig. 11C). This can indicate over-anchoring, e.g., that head 122 is submerged within tissue 5.

[0265] Figs. 12A-C illustrate anchor 120n having a compressible radiopaque layer (e.g., a cushion 130n) mounted on head 122 at a tissue-facing surface 126. In some implementations, as tissue-engaging element 124 is anchored into the tissue, cushion 130n becomes sandwiched between head 122 (e.g., tissue-facing surface 126 thereof), and the tissue surface. This sandwiching causes cushion 130n to become compressed and therefore change shape (e.g., deform), such that imaging the cushion during anchoring provides an indication of the position (e.g., the depth and / or orientation) of the anchor within the tissue.

[0266] In some implementations, cushion 130n is a layer of material, e.g., a fabric or a yarn. In some implementations, cushion 130n can be a variant of, or substantially identical to, layer 131 of disk 1301, except that it is radiopaque. This may be achieved by the cushion having a radiopaque yarn and / or wire woven into the material.

[0267] Fig. 12A illustrates anchor 120n partially anchored within tissue 5, but before cushion 130n abuts the tissue surface. At this stage, cushion 130n is in its non-compressed state. As the anchor becomes further anchored into the tissue, cushion 130n can assume a flattened or substantially linear state (Fig. 12B). During imaging of anchor 120n, observing that cushion 130n is in the flattened state may indicate that the anchor has been anchored to a required depth within the tissue, and that anchoring has been achieved.

[0268] In some implementations, a certain degree of compression of cushion 13 On can indicate adequate or desirable anchoring of anchor 120n, yet further compression of the cushion can indicate over-anchoring, e.g., that the head 122 is submerged within tissue 5 (Fig. 12C). For example, anchor 120n may be anchored into the tissue until cushion 130n becomes compressed to a predetermined thickness, or into a predetermined range of thicknesses, but further compression (e.g., and therefore further decrease in the cushion's thickness) may be indicative of over-anchoring. In some implementations, and as shown in Fig. 12C, over-anchoring of anchor 120n into the tissue may cause cushion 130n to bulge around the head.

[0269] Reference is now made to Fig. 13. In some implementations, and as mentioned hereinabove, any of indicators or imaging markers 130 described in Figs. 1A-12C can be used to assess an angle-of-attack at which anchor 120 has been driven into tissue 5. In some such implementations, balloon 130m can indicate whether the anchor has been driven into the tissue at an undesirable angle (e.g., oblique to the tissue surface), rather than perpendicularly to the tissue. Fig. 13 shows radiopaque balloon 130m as an example illustration of this idea, however, it is to be understood that any other of the indicators or imaging markers described herein could be used similarly.

[0270] In some implementations, balloon 130m can indicate the orientation and / or position of anchor 120m with respect to the tissue. For example, balloon 130m may be used to determine whether the anchor has been driven into the tissue at an undesirable angle (e.g., oblique with the tissue surface), rather than at an angle substantially perpendicular to the tissue (e.g., such that head 122 is generally parallel with the tissue). For example, should the anchor be driven in at such an undesirable anchor, fluid in balloon 130m may be pushed laterally, such that the balloon will appear asymmetrical during imaging. A user (e.g., physician) may adjust the anchor until the imaging marker is distributed symmetrically and / or uniformly along the tissue.

[0271] Reference is now made to Figs. 14A-B, which are schematic illustrations showing a system 200 that comprises an anchor 220, and an anchor delivery device 210 for delivering the anchor to the heart, in accordance with some implementations. Anchor 220 comprises a head 222, and a tissue-engaging element 224 that extends away from the head. In some implementations, anchor delivery device 210 comprises a driver 212 that comprises a handle 214 and a shaft 216. In some implementations, the driver comprises a drivehead 218 or other engagement means, e.g., clamp, interface, gears, friction fit, etc.

[0272] In some implementations, driver 212 is adapted to transluminally deliver the anchor to a tissue site of a subject (e.g., a living subject, a simulation, etc.) while head 222 of the anchor is reversibly engaged by the drivehead 218. Driver 212 can then anchor the anchor into the tissue e.g., by screwing the tissue-engaging element into the tissue while head 222 of the anchor 220 is engaged by the drivehead.

[0273] In some implementations, anchor 220, and / or anchor delivery device 210 that is used to deliver the anchor can be as described in one or more of the following references, mutatis mutandis, each of which is incorporated by reference in its entirety:US Patent Application Publication 2014 / 0309661 to Sheps et al.US Patent Application Publication 2015 / 0272734 to Sheps et al.US Patent Application Publication 2018 / 0049875 to Iflah et al.International Patent Application Publication WO 2024 / 121770 to Halabi et al.

[0274] In some implementations, anchor delivery device 210 further comprises an outer tube (e.g., sleeve) 233 that extends coaxially around shaft 216 and is affixed to drivehead 218. In some such implementations, outer tube 233 defines a radiopaque portion 230 (e.g., at a distal part of the tube) that can be used to provide an indication of the strength with which tissueengaging element 224 is anchored within the tissue, as described hereinbelow. Radiopaque portion 230 may be within 10cm of drivehead 218. Radiopaque portion 230 can be a spring, and / or can have an accordion-like structure. Radiopaque portion 230 may be formed by cutting (e.g., laser cutting) a distal portion of tube 233 to form slits and / or cuts, forming an axially stretchable zone along the tube. In some such implementations, the radiopaque portion is a discrete testing zone of reduced tensile strength that stretches axially, without becoming substantially narrower (e.g., without having a reduced diameter) responsively to being pulled.

[0275] In some implementations, shaft 216 itself defines radiopaque portion 230, e.g., the shaft that is used to transfer the anchoring force (e.g., torque) to the anchor defines the radiopaque portion, at a distal part thereof. In some such implementations, outer tube 233 may not be required.

[0276] In accordance with some implementations, anchor 220 is delivered to the heart and anchored into tissue 5 while radiopaque portion is in a non-stretched state (Fig. 14A). In some such implementations, the anchoring strength can then be tested by applying a proximal force to tube 233 (e.g., pulling a handle 235 of the tube), e.g., while the drivehead remains engaged with the head, and the tissue-engaging element remains anchored to the tissue. In some such implementations, radiopaque portion 230 is imaged while, or subsequently to, pulling tube 233, to view whether radiopaque portion 230 stretches axially (Fig. 14B).

[0277] In some implementations, the degree of stretching of radiopaque portion 230 can provide an indication of the extent or depth of tissue-engaging element 224 within the tissue. For example, if pulling tube 233 (e.g., with a predetermined amount of force) causes radiopaque portion 230 to stretch axially by a predetermined amount, then this provides anindication that anchor 220 (e.g., tissue-engaging element 224 thereof) is satisfactorily anchored within the tissue. In some implementations, should radiopaque portion not stretch by the predetermined amount (e.g., by less than the predetermined amount), this may indicate that the proximal pulling force applied to tube 233 is pulling tissue-engaging element 224 out of the tissue (e.g., de-anchoring the tissue-engaging element), therefore indicating that the anchor is unsatisfactorily anchored into the tissue.

[0278] In some implementations, the imaging is fluoroscopy, MRI, ultrasound, any combination thereof, and / or any other type of imaging.

[0279] In some implementations, during pulling of outer tube 233, (e.g., while anchor 220 remains anchored in tissue 5 of the heart, and connected to drivehead 218), radiopaque portion 230 is situated within the subject, such as within the thorax of the subject. For example, while radiopaque portion 230 is being imaged, the radiopaque portion is situated within the subject, optionally within the thorax and / or the heart of the subject.

[0280] Reference is now made to Figs. 15A-D, which are schematic illustrations showing a system 300 usable and / or for use at a tissue site of a subject (e.g., a living subject, a simulation, etc.). System 300 comprises an anchor 320, and a driver 310, in accordance with some implementations. Anchor 320 defines a head 322, and a tissue-engaging element 324 extending away from the head to define an anchor axis of the anchor. Driver 310 comprises a handle 314 at a proximal part of the driver and a shaft 316 extending distally from the handle.

[0281] In some implementations, the driver includes a drivehead 318 coupled to the shaft at a distal part of the driver, and configured to engage the head such that actuating the driver via the handle anchors tissue-engaging element 324 into the tissue. In some implementations, applying an anchoring force, such as torque, anchors the anchor into the tissue via shaft 316 transferring this anchoring force to drivehead 318, which in turn pushes tissue-engaging element 324 into the tissue.

[0282] In some implementations, anchor 320, and / or driver 310 that is used to deliver the anchor can be as described in one or more of the following references, mutatis mutandis, each of which is incorporated by reference in its entirety:US Patent Application Publication 2014 / 0309661 to Sheps et al.US Patent Application Publication 2015 / 0272734 to Sheps et al.US Patent Application Publication 2018 / 0049875 to Iflah et al.International Patent Application Publication WO 2024 / 121770 to Halabi et al.

[0283] In some implementations, driver 310 additionally comprises a rod 317 that extends, from the handle, distally through shaft 316, drivehead 318, and head 322, e.g., as shown in Fig. 15 A. In some implementations, rod 317 extends distally out of a tissue-facing surface 326 of head 322, and optionally alongside, or through, tissue-engaging element 324. For example, and as shown, if tissue-engaging element 324 is a helical tissue-engaging element, rod 317 may extend through the helix of the tissue-engaging element.

[0284] During anchoring of anchor 320 into tissue 5 via driver 310, as tissue-engaging element 324 is pushed into the tissue (Fig. 15B-C), the tissue pushes rod 317 proximally with respect to head 322 and handle. In some implementations, this proximal movement of rod 317, caused by tissue 5 pressing against the distal end of the rod, may cause a spring 311 in the handle to become gradually compressed. For example, rod 317 may have a wider portion that pushes proximally upon the spring (e.g., within a housing thereof).

[0285] In some implementations, a sensor 319, at a proximal part of driver 310 (e.g., at handle 314 thereof) is adapted to sense movement of the rod with respect to the handle, e.g., facilitated by the compression of spring 311. In some such implementations, an indicator 315, operatively coupled to sensor 319, may provide an indication, signal, or read-out responsively to the sensor sensing the pushing of the rod proximally with respect to the handle. The indicator may be mounted on the handle, e.g., as shown. In some implementations, indicator 315 provides an electronic indication, signal, or read-out, e.g., the indicator comprises a light that changes colors responsively to the sensor sensing that rod 317 is being pushed proximally. In some implementations, indicator 315 comprises a slider (e.g., a manual slider) that moves between different cards / colors as the rod progressively pushes the indicator proximally.

[0286] In some implementations, indicator 315 provides more than just a binary indication of whether rod 317 has been pushed proximally by the tissue. Rather, indicator 315 may be capable of providing a spectrum (e.g., a continuum) of indications, e.g., the indicator may provide a "nearly-there" indication when the extent of movement of rod 317 is indicative of tissue-engaging element 324 being nearly fully screwed into the tissue, but having not yet reached the desired depth (e.g., Fig. 15B may be showing this "nearly-there" setting). This may provide a warning to the user to proceed with caution, e.g., to prevent over-anchoringof the anchor at this last stage. Once the anchor has been fully anchored into the tissue, indicator 315 may switch to provide a "fully anchored" alert to the user (Fig. 15C), indicating that no further anchoring is required (or desired). Driver 310 can then be disengaged from head 322 (Fig. 15D), and the driver can then be withdrawn from the heart.

[0287] In some implementations, the disengagement between drivehead 318 and head 322 is facilitated by rod 317, e.g., the rod locks drivehead 318 to head 322, such that withdrawing the rod proximally within the drivehead disengages these two components. For example, rod can be a variant of, or substantially identical to, rod 130 of US Patent Application Publication 2015 / 0272734 to Sheps et al. In some implementations, anchoring anchor 320 fully into the tissue causes rod 317 to responsively move proximally by a predetermined amount, which automatically causes this disengagement, e.g., predetermined amount of proximal movement that occurs as a result of tissue 5 pushing against the rod during anchoring of the anchor corresponds to the predetermined amount that rod 317 needs to be pulled proximally in order to disengage the drivehead from the head 322 of the anchor.

[0288] In some implementations, spring 311 functions as indicator 315, e.g., the spring is visible to the user such that the extent of compression of the spring indicates the depth of tissue-engaging element 324 within tissue 5. In some such implementations, a discrete indicator 315 may not be required.

[0289] In some implementations, rod 317 can additionally or alternatively be used as an imaging marker within the heart, e.g., during anchoring of anchor 320 within the heart, the position of the distal end of rod 317 with respect to head 322 may indicate the depth of tissueengaging element 324 within the tissue. For example, and as seen in the proximal progression of the distal end of rod 317 between Figs. 15A-D, as the tissue-engaging element is progressively anchored into the tissue, distal end of rod 317 moves closer and closer (and optionally fully into) head 322, and no longer juts out of the head.

[0290] Reference is now made to Figs. 16A-B, which are schematic illustrations showing a system 400 comprising an anchor 420 and a driver 410 for driving the anchor into tissue 5, in accordance with some implementations.

[0291] In some implementations, anchor 420, and / or driver 410 that is used to deliver the anchor can be as described in one or more of the following references, mutatis mutandis, each of which is incorporated by reference in its entirety:US Patent Application Publication 2014 / 0309661 to Sheps et al.US Patent Application Publication 2015 / 0272734 to Sheps et al.US Patent Application Publication 2018 / 0049875 to Iflah et al.International Patent Application Publication WO 2024 / 121770 to Halabi et al.

[0292] In some implementations, anchor 420 comprises a tissue-engaging element 424 and a head 422 attached to the tissue-engaging element. In some implementations, the anchor comprises an indicator. In some implementations, the indicator is or comprises a piezoelectric inclusion 430. In some implementations, piezoelectric inclusion 430 can be a piezoelectric crystal and / or can comprise a ceramic material. In some implementations, piezoelectric inclusion 430 is configured to generate piezoelectricity responsively to the pressing of head 422 against the tissue.

[0293] In some implementations, driver 410 comprises a handle 414 at a proximal part of the driver, a shaft 416 extending distally from the handle, and a drivehead 418 coupled to the shaft at a distal part of the driver that is adapted to engage head 422, e.g., an interface 423 of the head. It is to be understood that the head of any other anchor described herein may comprise interface 423, or a variant thereof.

[0294] While head 422 is engaged with drivehead 418, driver 410 is adapted to drive tissueengaging element 424 into the tissue until the head presses against the tissue. This causes indicator or piezoelectric inclusion 430 to become squashed and / or compressed, thereby generating piezoelectricity that is conducted from head 422 to the proximal part of the driver (e.g., to handle 414).

[0295] In some implementations, and as shown, indicator or piezoelectric inclusion 430 is disposed at a tissue-facing surface 426 of the head, such that anchoring anchor 420 into the tissue causes the piezoelectric inclusion to become pressed (e.g., compressed and / or squeezed) against a surface of the tissue (e.g., without penetrating the tissue, as shown in Fig. 16B).

[0296] In some implementations, a significant portion of head 422 (e.g., the entire head, or a major part of the head) can comprise and / or be formed from a piezoelectrically conductive material. In some such implementations, a discrete piezoelectric inclusion is not necessarily, as the entire head, or a significant portion thereof, acts in the place of a discrete piezoelectric inclusion.

[0297] In some implementations, shaft 416 is electrically conductive, and can thereby conduct the piezoelectricity. In some implementations, driver 410 comprises a rod (not shown), extending through shaft 416 to drivehead 418, the rod controlling engagement of the drivehead with head 422. For example, rod can be a variant of, or substantially identical to, rod 130 of US Patent Application Publication 2015 / 0272734 to Sheps et al. In some such implementations, the rod is adapted to conduct piezoelectricity from piezoelectric inclusion 430 to the sensor.

[0298] In some implementations, a connector 412 (e.g., a wire) extends, from piezoelectric inclusion 430, proximally along the shaft (e.g., within the shaft, or alongside the shaft) to the proximal part of the driver, in order to conduct the piezoelectricity.

[0299] In some implementations, a sensor mounted on, or in the vicinity of, handle 414 is adapted to sense the conducted piezoelectricity. In some such implementations, and as shown, system 400 comprises a processor 417, electrically connected to the sensor, and adapted to responsively to the sensed piezoelectricity, provide an indication of contact between head 422 and the tissue surface. For example, processor 417 may provide this indication via a visual output (e.g., by lighting up responsively to receiving the piezoelectricity), an audio output and / or haptic feedback.

[0300] In some implementations, once it has been determined that anchor 420 has been anchored into the tissue satisfactorily, e.g., responsively to the indication of contact provided by processor 417, driver 410 can be disconnected from the anchor and withdrawn from the heart. In some such implementations, withdrawal of driver 410 from the anchor disconnects (e.g., electrically disconnects) processor 417 from the anchor.

[0301] In some implementations, tissue-engaging element 424, and / or tissue-facing surface 426 of head 422, is electrically isolated from piezoelectric inclusion 430, e.g., in order to prevent the piezoelectricity generated by the compression of piezoelectric inclusion 430 from reaching the tissue. This may advantageously prevent the tissue from becoming injured by the generated current, and / or ensure that the generated current reaches processor 417, e.g., instead of being lost to the tissue.

[0302] Reference is now made to Figs. 17A-C, which illustrate an example system 400a that comprises an anchor 420a, and a driver 410a for driving the anchor into tissue 5, in accordance with some implementations. System 400a can be considered to be a variant of system 400, e.g., it can include the same or similar features. Components of system 400a(e.g., anchor 420a and driver 410a) may be as described for corresponding components of system 400, except when noted otherwise.

[0303] In some implementations, anchor 420a comprises a tissue-engaging element 424, and a head 422a attached to the tissue-engaging element. In some implementations, head 422a comprises, or is attached to, an indicator or disk 430a that has a piezoelectric material 432 included (e.g., woven) therein. Disk 430a can be formed from any material or fabric that is interwoven with, or includes, a piezoelectric material or thread. Similarly to piezoelectric inclusion 430, disk 430a is configured to generate piezoelectricity responsively to the pressing of head 422a against the tissue, e.g., by piezoelectric material 432 of the disk becoming compressed between the head and the tissue.

[0304] In some implementations, piezoelectric material 432 is a yarn, textile, and / or fabric. In some implementations, piezoelectric material 432 is a coating on a yarn or material (e.g., a coating on a fabric / textile).

[0305] Piezoelectric material 432 (e.g., yarn or material) may be a yarn formed from a polymer. Examples of substances that may be included in such a yarn include: Polyethylene terephthalate (PET), a polymer polyvinylidene fluoride (PVDF), aluminum nitride, Barium Titanate, Lithium tantalate, potassium sodium tartrate, potassium niobate, and / or polypeptide poly(benzyl glutamate) (PBLG).

[0306] In some implementations, driver 410a comprises a handle 414a at a proximal part of the driver and a shaft 416 extending distally from the handle. In some implementations, a drivehead 418 coupled to the shaft at a distal part of the driver that is adapted to engage head 422a. In some implementations, driver 410 is adapted to drive tissue-engaging element 424 into the tissue until the head presses against the tissue, e.g., while head 422a is engaged with drivehead 418. This can cause at least part of disk 430a to become squashed and / or compressed between head 422a and the tissue, thereby generating piezoelectricity, which is conducted from head 422a to the proximal part of the driver (e.g., to handle 414a) using any of the means described with reference to system 400 (e.g., via a conducting wire). The proximal part of the driver (e.g. handle 414a) responsively displays an indication that the anchor has been fully anchored.

[0307] Figs. 17A-C can be considered to be a series of steps taken in order to engage anchor 420a into tissue 5. Disk 430a can initially be flat, e.g., flush and parallel with tissue-facing surface 426 (Fig. 17A). Anchoring tissue-engaging element 424 into tissue 5 causes head422a to progressively press, or squash, disk 430a between the head and the tissue surface, causing the disk to become somewhat compressed, and thereby generating piezoelectricity (Fig. 17B). In some implementations, and as described hereinabove with reference to system 400, a sensor mounted on, or in the vicinity of, handle 414a is adapted to sense the conducted piezoelectricity. In some such implementations, and as shown, system 400a comprises a processor 417a, electrically connected to the sensor, and adapted to, responsively to the sensed piezoelectricity, provide an indication of contact between head 422a and the tissue surface. For example, processor 417a may provide this indication via a display 419 (e.g., by lighting up responsively to receiving the piezoelectricity), a visual output, an audio output and / or haptic feedback.

[0308] In some implementations, processor 417a is configured such that display 419 provides a binary output (e.g. piezoelectrical energy sensed / piezoelectrical energy not sensed). Receiving an indication that piezoelectric energy has been sensed at handle 414a can be an indication that disk 430a has become sandwiched and compressed between the head and the tissue, informing the user (e.g., physician) that anchoring is complete, or nearcompletion. This may provide the user with a warning that further anchoring could cause over-tightening of the anchor, which could cause damage to the tissue.

[0309] In some implementations, system 400a (e.g. driver 410a) is preconfigured with a threshold value of piezoelectric current and / or voltage, the threshold value being indicative of anchoring completeness (e.g., that enough piezoelectric energy has been detected, and that further anchoring would damage the tissue.) This may cause display 419 to switch to an “anchoring-complete” indicating state.

[0310] In some implementations, rather than simply providing a binary output, display 419 provides an indication of the amount of piezoelectrical energy received by the sensor. For example, in some implementations, display 419 can show the numeric values of current / voltage generated by the piezoelectric material. In some implementations, display 419 can show multiple discrete states (e.g., colors and / or shapes) that it switches between responsively to the amount of piezoelectricity sensed. In some such implementations, it is advantageous to continuously assess, during driving of the anchor into the tissue, the amount of piezoelectric energy generated. In some implementations, a bell-curve effect may be observed. For example, as anchor 420a is initially driven into the tissue no piezoelectricity, or a minimal amount of piezoelectricity may be sensed. As disk 430a is graduallycompressed between the head and the tissue surface, progressively larger amounts of piezoelectric energy may be sensed by handle 414a.

[0311] In some implementations, a lack of additional detection of piezoelectricity upon further driving of anchor 420a may be indicative that anchoring is complete or nearcompletion.

[0312] In some implementations, display 419 can switch between different colors or discrete markings. For example, display 419 can show a green display when no, or minimal, piezoelectricity is sensed (e.g., prior to disk 430a contacting the tissue surface, Fig. 17A). As the disk becomes progressively pressed against the tissue surface, the display can switch to orange during the final stages of anchoring, as the head becomes progressively pressed against the tissue surface. This may serve as a warning to the user that anchoring is near, or has reached, completion. Display 419 can turn to red during peak compression of disk 430a (at the final stage of anchoring, or if the anchor is being over-tightened, Fig. 17B). Further anchoring of the anchor into the tissue may result in a drop in piezoelectric energy sensed at handle 414, causing the display to switch to orange, and then green, as progressively less piezoelectric energy is sensed (Fig. 17C).

[0313] In some implementations, processor 417a and / or display 419 can be used with system 400, e.g., processor 417 could similarly provide or display a continuum of indications during anchoring of anchor 420. In some implementations, processor comprises a display, such as display 419.

[0314] In some implementations, disk 430a is not initially a component of head 422a. For example, disk 430a could be a variant of disk 130k, e.g., the disk could initially be attached to the tissue-engaging element (or positioned on the tissue surface) and become progressively closer to head 422 during anchoring (e.g., as shown in Figs. 9A-B).

[0315] In some implementations, disk 430a comprises an inner region 436 that is electrically isolated from an outer region 438 of the disk. Each of regions 436 and 438 are formed from, or include, a piezoelectric material. For example, inner region 436 can include a first piezoelectric inclusion 432’ (e.g., formed from a first piezoelectric yarn or material), and outer region 438 can include a second piezoelectric inclusion 432” (e.g., formed from a second, independent piezoelectric yarn or material) that is electrically isolated from the first piezoelectric inclusion. In some such implementations, separate connectors connect inner region 436 (e.g., first piezoelectric inclusion 432’) to processor 417a, and outer region 438(e.g., second piezoelectric inclusion 432”) to processor 417a. In some implementations, regions 436 and 438 are electrically and / or spatially separated by a gap 437, e.g., a band in the disk formed from non-piezoelectric producing material. In some implementations, as anchor 420 becomes anchored to the tissue, and head 422a presses against disk 430a, region 436 begins generating piezoelectricity, which is identified by processor 417a - e.g. as described hereinabove. In some implementations, receiving a signal that piezoelectricity has been generated by outer region 438 is indicative that over-anchoring is occurring. For example, as shown in Fig. 17C, once head becomes overly pressed against, or submerged within the tissue, outer region 438 may become deformed, thereby generating piezoelectricity. Thus, in some implementations, driver 410a may be configured to (i) indicate full anchoring upon detecting a piezoelectric signal from region 436 (e.g., from inclusion 432’), and (ii) indicate over-anchoring upon detecting a piezoelectric signal from region 438 (e.g., from inclusion 432”).

[0316] In some implementations, it may be desired that head 422a becomes pressed against, or submerged within, the tissue in a manner in which processor 417a receives a signal that piezoelectricity has been generated by both regions 436 and 438. For example, in some such implementations, it may be desired that the head become partially, but not fully, submerged within the tissue. In some implementations, it may be desired that the head become fully submerged within the tissue. Thus, in some implementations, driver 410a may be configured to indicate full anchoring upon detecting a piezoelectric signal from both (i) region 436, and (ii) region 438. For example, driver 410a may indicate partial anchoring upon detecting a piezoelectric signal from region 436 (e.g., from inclusion 432’), and full anchoring upon detecting a piezoelectric signal from region 438 (e.g., from inclusion 432”).

[0317] Reference is now made to Figs. 18A-C, 19, and 20, which illustrate a system 500, in accordance with some applications. System 500 comprises an anchor 520 defining a head 522, and a tissue-engaging element 524 extending away from the head to define an anchor axis of the anchor. System 500 also comprises a delivery tool 510, adapted to implant the anchor 520 into tissue 5 of a subject. In some implementations, anchor 520 can be a component of an annul oplasty implant, and delivery tool 510 can be adapted to implant the annul oplasty implant along an annulus of a subject.

[0318] In some such implementations, tissue 5 can be tissue of an annulus of a heart.

[0319] In some implementations, tool 510 comprises an anchor driver 512 that has a shaft 516. In some implementations, the tool 510 can include a drivehead 518 at a distal end ofthe shaft. In some implementation, the driver adapted to engage anchor 520 into the tissue by driving tissue-engaging element 524 into tissue of the heart (which can be done while the drivehead is engaged with head 522), e.g., as described hereinabove with respect to driver 212.

[0320] In some implementations, tool 510 also comprises a catheter 560, the driver adapted to transluminally deliver the anchor via the catheter (e.g., while ensheathed within the catheter) to the heart.

[0321] In some implementations, catheter 560 has a distal portion 5602 that comprises a radiopaque proximal marker 562, a radiopaque distal marker 566, and a compressible zone 564 therebetween. Compressible zone 564 can be compressible (e.g., as will be described hereinbelow) such that, via application and release of an axially -compressive force to distal portion 5602 (e.g., a distal pressing force of the catheter against the tissue), the distal portion is reversibly transitionable between: an extended state in which the proximal marker and the distal marker are fluoroscopically distinguishable from each other (Fig. 18 A), and a compressed state in which the proximal marker and the distal marker are fluoroscopically indistinguishable from each other (Fig. 18B).

[0322] Catheter 560 can be used with any of the anchors, drivers, systems, methods, etc. disclosed anywhere herein.

[0323] In some implementations, zone 564 is compressible by being adapted to collapse (e.g., buckle) responsively to the compressive force applied to distal portion 5602.

[0324] In some such implementations, proximal marker 562 becomes nested, or positioned coaxially within, zone 564 responsively to being transitioned towards the compressed state. In some such implementations, zone 564 is simply less rigid than a more proximal portion 5604 of the catheter, such that pressing the distal portion against the tissue causes zone 564 to collapse.

[0325] In some implementations, distal portion 5602 (e.g., zone 564 thereof) is biased to being in its extended state, such that cessation of the axially-compressive force causes zone 564 to “pop” back towards its extended state.

[0326] In some implementations, zone 564 is compressible such that marker 562 contacts, or moves distally towards, marker 566. In some implementations, compressible zone 564 defines struts (e.g., is stent-like), such that compressing zone 564 causes the struts to axiallydeform (e.g., such that the compressible zone foreshortens). In some implementations, compressible zone 564 is braided, the braid being axially compressible.

[0327] Figs. 18A-D can be considered to be a series of steps illustrating the transluminal delivery and the subsequent anchoring of an anchor 520 to tissue 5 of the heart. Catheter 560 is transluminally advanced towards a target tissue 5 of a subject (e.g., tissue of an annulus of a heart), until the catheter abuts the tissue (Fig. 18 A). During the transluminal advancement of the catheter, anchor driver 512 can be disposed within the catheter, with anchor 520, engaged by anchor driver 512, positioned within a distal part of the catheter. Alternatively, anchor 520 can be advanced to the heart once catheter 560 has been positioned against the tissue, e.g., catheter 560 can be advanced to the tissue without anchor 520 and anchor driver 512 being disposed therewithin.

[0328] Once a distal end of catheter 560 contacts the tissue (Fig. 18 A), further advancement of catheter 560 in a distal direction causes compressible zone 564 to compress or collapse, due to a counterforce exerted by the tissue surface, causing proximal radiopaque marker 562 to move distally towards distal radiopaque marker 566 (Fig. 18B). This renders the two radiopaque markers indistinguishable from each other (e.g., displaying as a single, unified marker when imaged). In some implementations, viewing the two radiopaque markers 562 and 566 as fluoroscopically indistinguishable provides an indication that catheter 560 (i) is pressing against the tissue, and / or (ii) is pressing against the tissue in a satisfactory and / or symmetrical orientation. This can indicate that the catheter is in a suitable orientation and / or position with respect to the tissue to begin anchoring.

[0329] In some implementations, once it has been determined, via fluoroscopic imaging of distal portion 5602, that the two radiopaque markers 562 and 566 are fluoroscopically indistinguishable, anchor 520 can subsequently be anchored to the tissue, through distal portion 5602 (Figs. 18C-D). In some implementations, head 522 also comprises a radiopaque marker 525, such that once tissue-engaging element 524 becomes fully submerged within the tissue, marker 525 becomes fluoroscopically indistinguishable from markers 562 and 566 (Fig. 18D). Having all three markers aligned (e.g., imaging a single, unified radiopaque marker) provides an indication to the user (e.g., physician) that anchoring is complete. That is, this is an indication that head 522 is abutting the tissue surface, and that further anchoring may cause head 522 to undesirably become submerged within the tissue.

[0330] Reference is now made to Fig. 19. Once anchor 520 has been anchored to the tissue (e.g., once it has been determined fluoroscopically that markers 562, 525, and 566 havebecome indistinguishable and / or aligned, Stage 1 of Fig. 19), a “pull-test” can be performed to determine whether the anchor is well-anchored within the tissue (e.g., has sufficient anchoring-strength within the tissue to prevent de-anchoring). Fig. 19 illustrates such a “pulltest”. A proximally-directed force (e.g., a “pulling” or “de-anchoring” force) is applied to anchor 520 via driver 512 (e.g., while drivehead 518 remains engaged with head 522), while imaging distal portion 5602. If all three markers remained indistinguishable (Stage 2A), then it is indicative that the anchor is well-anchored to the tissue. This is because minimal or no movement of marker 525 with respect to markers 562 and 566 is indicative of anchor 520 providing sufficient counter-force within the tissue to prevent the anchor from becoming deanchored.

[0331] In some such implementations, marker 525 may be observed moving transiently out of alignment with markers 562 and 566, but then immediately returning to alignment with the markers. It is to be understood that this transient movement may not be indicative of de- anchoring.

[0332] If, however, anchor 520 does not have sufficient anchoring-strength within the tissue, pulling anchor 520 proximally may pull the anchor out of the tissue, causing marker 525 to thereby move out of alignment with markers 562 and 566 (Stage 2B). Thus, viewing the separation of a single, unified marker (e.g., markers 562, 525, 566 in their fluoroscopically indistinguishable state) to viewing two discrete markers that are fluoroscopically distinguishable from each other (Stage 2B) can be indicative that the anchor is insufficiently anchored to the tissue.

[0333] Fig. 20 illustrates an alternative way to perform such a pull-test, in accordance with some implementations. Once anchor 520 has been anchored into the tissue, which can occur while drivehead 518 remains engaged with the anchor, distal portion 5602 is transitioned from its compressed state to its extended state (as illustrated by the transition of distal portion between Stage 1 and Stage 2 of Fig. 20). As mentioned above, zone 564 can be biased to return to its extended state, such that this transition is performed by simply releasing the catheter from being pressed against the tissue. In the extended state, two discrete markers can be viewed under fluoroscopy: (i) marker 566 (optionally aligned with marker 525 as a single unified marker), and (ii) marker 562. A proximally-directed force (e.g., a “pull-test”) is then applied to anchor 520, via driver 512.

[0334] In situations in which anchor 520 is well-anchored to the tissue, pulling anchor 520 proximally causes the tissue to be pulled proximally therealong, the tissue thus exerting aproximally-directed force against distal portion 5602. If anchor 520 is sufficiently well- anchored with the tissue, the tissue exerts sufficient force against distal portion 5602 to transition the distal portion back towards its compressed state (e.g., by compressing or collapsing zone 564, Stage 3A).

[0335] In some implementations, zone 564 must be sufficiently weak such that pulling anchor 520 proximally transitions distal portion 5602 to its compressed state. However, if anchor 520 is not well -anchored within the tissue, pulling anchor 520 proximally results in the anchor moving proximally out of the tissue (rather than the tissue moving therewith), such that zone 564 does not compress and / or collapse, the two markers thereby remain distinguishable under fluoroscopy (Stage 3B).

[0336] In some implementations, in which head 522 has its own marker 525 thereon, all three markers may become independently distinguishable as marker 525, along with head 522, moves proximally out of alignment with marker 566 towards marker 562.

[0337] In some implementations, catheter 560 is not keyed and / or coupled to driver 510. In some implementations, catheter 560 is keyed and / or coupled to driver 510.

[0338] Reference is now made to Fig. 21, which illustrates a system 500a, which can be identical to system 500 except when noted otherwise. System 500a comprises a catheter 560a, through which an anchor 520 can be anchored to the tissue. As described with reference to catheter 560, catheter 560a has a distal portion 5602a, a distal end of which becomes pressed against the tissue upon contact therewith.

[0339] In some implementations, rather than comprising only two radiopaque markers 562 and 566, distal portion 5602a comprises multiple radiopaque markers 569 (e.g., a series of radiopaque markers) spaced axially along the distal portion, with compressible or collapsible zones 564 between the markers.

[0340] In some implementations, having multiple markers 569 can provide the user with a scale that provides an indication of the force that the catheter is pressing against the tissue, e.g., in order to determine that the catheter is satisfactorily positioned prior to anchoring.

[0341] In some implementations, if a sufficient number of markers 569 have become fluoroscopically indistinguishable, it is indicative that the catheter is exerting sufficient force against the tissue.

[0342] In some implementations, such a scale also provides an indication of the orientation of the catheter with respect to the tissue.

[0343] In some implementations, such a scale can provide an indication of the anchoringstrength of the anchor within the tissue. For example, as described with respect to Fig. 20, distal portion 5602 can be reverted back to its extended state (e.g., in which all the compressible zones are extended, as shown in Fig. 21), and a “pull-test” can then be applied to the anchor via an anchor driver 510a to determine whether the anchoring-strength of the anchor is sufficient to transition the compressible zones back to their compressed states.

[0344] In some implementations, the anchoring-strength of the anchor within the tissue is determined by the amount of force required to collapse each progressively proximal compressible zone (e.g., determined by the markers becoming fluoroscopically indistinguishable). In this manner, the series of markers 569 provide a scale (e.g., a continuum of discrete markings) for the user to discern the anchoring-strength of the anchor within the tissue.

[0345] In some implementations, an anchor driver 510a is used which has fluoroscopic marker(s) 568 at a distal end of a shaft 518a of the driver. Markers 568 may be in the place of, or in addition to, marker 525 on head 522.

[0346] In some implementations, markers 568 can be used to determine whether anchoring of anchor 520 is complete and / or successful (e.g., at a suitable angle). For example, catheter 560a and driver 510a may be configured such that once tissue-engaging element 524 is fully submerged within the tissue, each marker 568 becomes aligned (e.g., fluoroscopically indistinguishable) from a respective marker 569 on distal portion 5602a. In some implementations, a single marker 568 becomes aligned with a single marker 569 on the distal portion (e.g., in implementations in which only a single radiopaque marker 569 is disposed at distal portion 5602a).

[0347] In some implementations, multiple markers 569 become aligned with multiple radiopaque markers 568, e.g., as shown.

[0348] In some implementations, the “pull-test” can be performed by assessing movement of markers 568 with respect to markers 569. For example, once markers 568 have become fluoroscopically indistinguishable from markers 569 (once anchor 520 has been anchored into the tissue), if the anchor is well-seated within the tissue, pulling anchor 520 proximally may cause markers 568, 569 to remain substantially aligned and / or indistinguishable withrespect to each other (e.g., except for a transient movement of marker 568). If, however, the anchor is tugged out of the tissue responsively to the pulling-force, markers 568 and 569 may permanently move out of alignment with each other, thereby becoming fluoroscopically distinguishable, signifying to the user that the anchor is inadequately anchored.

[0349] The present disclosure includes different variants of some elements. Variants of a given element may 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, implementations of the devices, systems, and techniques described herein can 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 can be substituted with each other, mutatis mutandis. That is, unless stated otherwise, any element having a given reference numeral can be substituted with any other element (e.g., any other variant of the element) having the same reference numeral, independent of any suffix.

[0350] 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.

[0351] 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 some disclosed implementations and applications, alone and in some 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.

[0352] For some implementations, and as shown, the data-processing system is, or is a component of, a discrete (e.g., purpose-made) device. For 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.

[0353] In the present disclosure, the term data-processing system can refer to, be part of, or include an Application Specific Integrated Circuit (ASIC); a digital, analog, or mixedanalog / 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, can include software, firmware, and / or microcode, and can 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 can 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 tangible computer readable medium include nonvolatile memory, volatile memory, magnetic storage, and optical storage.

[0354] 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.).

[0355] 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.

[0356] Example Implementations (some non-limiting examples of the concepts herein are recited below):

[0357] Example 1. A system for use at a (real or simulated) heart of a subject, the system comprising: (i) an anchor comprising: (a) a tissue-engaging element; and / or (b) a head comprising a piezoelectric inclusion; (ii) a driver, comprising: (a) a handle at a proximal part of the driver, (b) a shaft extending distally from the handle, and / or (c) a drivehead defined by the shaft at a distal part of the driver, the driver adapted to, via engagement between the head and the drivehead: (I) drive the tissue-engaging element into tissue of the heart until the head presses against a surface of the tissue, the piezoelectric inclusion configured to generate piezoelectricity responsively to the pressing of the head against the tissue; and / or (II) conduct the piezoelectricity from the head to the proximal part of the driver; and / or (iii) a sensor, adapted to sense the conducted piezoelectricity.

[0358] Example 2. The system according to example 1, wherein the head comprises: (i) an interface, configured to be engaged by a drivehead of the driver; and / or (ii) a disk that comprises the piezoelectric inclusion, the disk positioned with respect to the interface such that the disk becomes pressed against the tissue responsively to anchoring of the anchor into the tissue.

[0359] Example 3. The system according to example 2, wherein the piezoelectric inclusion is a piezoelectric yarn, woven into the disk.

[0360] Example 4. The system according to any one of examples 2-3, wherein the disk can comprise and / or be formed from a piezoelectric textile.

[0361] Example 5. The system according to any one of examples 2-4, wherein the disk comprises one or more of Polyethylene terephthalate (PET), polymer polyvinylidene fluoride (PVDF), aluminum nitride, Barium Titanate, Lithium tantalate, potassium sodium tartrate, potassium niobate, and polypeptide poly(benzyl glutamate) (PBLG).

[0362] Example 6. The system according to any one of examples 2-5, wherein the head defines a body, the body defining the interface, and wherein the disk is attached to a tissuefacing surface of the body.

[0363] Example 7. The system according to any one of examples 2-6, wherein the disk is threaded onto the tissue-engaging element in a manner in which driving the tissue-engaging element into the tissue causes the disk to get progressively closer to the interface by the disk remaining at a surface of the tissue.

[0364] Example 8. The system according to any one of examples 2-6, wherein: (i) the piezoelectric inclusion is a first piezoelectric inclusion, an inner region of the disk comprising the first piezoelectric inclusion, (ii) the disk further comprises a second piezoelectric inclusion, an outer region of the disk comprising the second piezoelectric inclusion, and / or (iii) the disk is positioned with respect to the interface such that the inner region of the disk becomes pressed between a tissue-facing surface of the head and the tissue responsively to anchoring of the anchor into the tissue, and the outer region of the disk does not become pressed by the tissue-facing surface.

[0365] Example 9. The system according to example 8, wherein the first piezoelectric inclusion is electrically isolated from the second piezoelectric inclusion.

[0366] Example 10. The system according to example 8, wherein the disk defines a band in between the inner region and the outer region, the band comprised of a non-piezoelectric material.

[0367] Example 11. The system according to any one of examples 1-10, wherein the piezoelectric inclusion is a piezoelectric crystal.

[0368] Example 12. The system according to any one of examples 1-11, wherein the piezoelectric inclusion comprises a ceramic, polymeric, natural, or organic material.

[0369] Example 13. The system according to any one of examples 1-12, wherein the sensor is configured to, responsively to the sensed piezoelectricity, provide an indication of contact between the head and the tissue surface.

[0370] Example 14. The system according to any one of examples 1-13, wherein: the piezoelectric inclusion is disposed at a tissue-facing surface of the head, and / or the driver is adapted to drive the tissue-engaging element into the tissue such that the piezoelectric inclusion becomes pressed against a surface of the tissue without penetrating the tissue.

[0371] Example 15. The system according to any one of examples 1-14, wherein the head can comprise and / or be formed from a piezoelectrically conductive material, and wherein the sensor is adapted to sense the conducted piezoelectricity via the head.

[0372] Example 16. The system according to any one of examples 1-15, wherein the driver is disengageable from the head within the heart.

[0373] Example 17. The system according to any one of examples 1-16, wherein: the shaft is adapted to conduct piezoelectricity, and / or the sensor is adapted to sense the conducted piezoelectricity via the shaft.

[0374] Example 18. The system according to any one of examples 1-17, wherein: the driver further comprises a rod, extending through the shaft to a drivehead of the driver, configured to control engagement of the drivehead with the head, the rod being adapted to conduct piezoelectricity, and / or the sensor is adapted to sense the conducted piezoelectricity via the rod.

[0375] Example 19. The system according to any one of examples 1-18, wherein: the driver further comprises a connector, extending through the shaft, the connector being adapted to conduct piezoelectricity, and / or the sensor is adapted to sense the conducted piezoelectricity via the connector.

[0376] Example 20. The system according to example 19, wherein the connector is a wire.

[0377] Example 21. The system according to any one of examples 1-20, further comprising a processor, electrically connected to the sensor, and adapted to responsively to the sensed piezoelectricity, provide an indication of contact between the head and the tissue surface.

[0378] Example 22. The system according to example 21, wherein the processor is adapted to provide an indication of current or voltage of the piezoelectricity sensed by the sensor.

[0379] Example 23. The system according to example 21, wherein the processor is adapted to provide a stop signal upon current or voltage of the piezoelectricity exceeding a predetermined threshold, the stop signal being an indication of anchoring-completeness.

[0380] Example 24. The system according to example 21, wherein: (a) the anchor further comprises a disk that comprises the piezoelectric inclusion, and / or (b) the disk is positioned with respect to the head such that an inner region of the disk becomes pressed between a tissue-facing surface of the head and the tissue responsively to anchoring of the anchor into the tissue, and an outer region of the disk does not become pressed by the tissue-facing surface.

[0381] Example 25. The system according to example 24, wherein the processor is adapted to provide (i) the indication of contact between the head and the tissue surface upon detecting a piezoelectric signal from the inner region, and (ii) indicate over-anchoring upon detecting a piezoelectric signal from the outer region.

[0382] Example 26. The system according to example 24, wherein the inner region and the outer region are electrically isolated from each other.

[0383] Example 27. The system according to example 26, wherein a first connector connects the inner region to the processor, and a second connector connects the outer region to the processor, the first connector and the second connector being electrically isolated from each other.

[0384] Example 28. The system according to example 24, wherein the processor is adapted to provide the indication of contact between the head and the tissue surface upon detecting a piezoelectric signal from both the inner region and the outer region.

[0385] Example 29. The system according to example 21, wherein the anchor is disconnectable from the processor subsequently to driving the tissue-engaging element into the tissue, by disengaging the driver from the head.

[0386] Example 30. A system for use at a (real or simulated) heart of a subject, the system comprising an anchor that comprises: (i) a tissue-engaging element; and / or (ii) a head comprising a piezoelectric inclusion.

[0387] Example 31. The system according to example 30, further comprising a driver that is adapted to, via engagement between the head and the driver: (i) drive the tissue-engaging element into tissue of the heart until the head presses against a surface of the tissue, the piezoelectric inclusion configured to generate piezoelectricity responsively to the pressing of the head against the tissue; and / or (ii) conduct the piezoelectricity from the head to a proximal part of the driver.

[0388] Example 32. The system according to example 31, wherein the driver comprises: (i) a handle at a proximal part of the driver, (ii) a shaft extending distally from the handle, and / or (iii) a drivehead defined by the shaft at a distal part of the driver.

[0389] Example 33. The system according to example 30, further comprising a sensor, adapted to sense the piezoelectricity.

[0390] Example 34. The system according to example 33, further comprising a processor, electrically connected to the piezoelectric inclusion, and adapted to pressing of the head against tissue of the heart, provide an indication of contact between the head and a surface of the tissue.

[0391] Example 35. An anchor defining a head and a tissue-engaging element extending away from the head, wherein the anchor further comprises an indicator coupled to at least one of the head or the tissue-engaging element and adapted to move with respect to at least one of the head and the tissue-engaging element responsively to the anchor being inserted in tissue of a subject.

[0392] Example 36. The anchor according to example 35, wherein the indicator is a disk positioned at or near a tissue-facing surface of the head.

[0393] Example 37. The anchor according to any one of examples 35-36, wherein the indicator comprises a radiopaque element that extends around a perimeter of the disk.

[0394] Example 38. The anchor according to any one of examples 35-36, wherein the indicator comprises a radiopaque element that extends in a spiral along a surface of the disk.

[0395] Example 39. The anchor according to any one of examples 35-38, wherein the indicator comprises one or more radiopaque elements that extend concentrically around a surface of the disk.

[0396] Example 40. The anchor according to any one of examples 35-39, wherein the indicator is a balloon, whereby anchoring the tissue-engaging element into the tissue causes the balloon to become sandwiched between the head and the tissue, thereby changing a shape of the balloon.

[0397] Example 41. The anchor according to any one of examples 35-39, wherein the indicator is or comprises a disk.

[0398] Example 42. The anchor according to example 41, wherein anchoring the tissueengaging element into the tissue causes the disk to at least one of: cup or shape around the head and / or curl around the head.

[0399] Example 43. The anchor according to any one of examples 35-43, wherein: (i) the indicator comprises: (a) a compressible layer, (b) a first radiopaque layer, and / or (c) a second radiopaque layer separated from the first radiopaque layer by the compressible layer, and / or (ii) the indicator is mounted on the anchor whereby anchoring the tissue-engaging elementinto the tissue causes the indicator to become sandwiched between the head and the tissue, such that the compressible layer becomes compressed, and the first and second radiopaque layers move towards each other.

[0400] Example 44. The anchor according to any one of examples 35-43, wherein the indicator comprises an imaging element that is connected to the head via a cord, such that the imaging element is adapted to change position with respect to the head, responsively to the anchor being inserted in the tissue, by remaining above a surface of the tissue.

[0401] Example 45. The anchor according to example 44, wherein one or both of the cord and the imaging element is radiopaque.

[0402] Example 46. The anchor according to any one of examples 35-45, wherein the indicator is a compressible layer positioned at a tissue-facing surface of the head whereby anchoring the tissue-engaging element into the tissue causes the compressible layer to become sandwiched between the head and the tissue, thereby compressing the compressible layer.

[0403] Example 47. The anchor according to example 46, wherein the compressible layer is a cushion.

[0404] Example 48. The anchor according to any one of examples 35-47, wherein: (i) the indicator is a disk positioned at a tissue-facing surface of the head, (ii) the anchor is anchorable into the tissue while the indicator is in a first cupped state in which the disk defines a concavity that faces towards the tissue, and / or (iii) the indicator is transitionable towards a second cupped state, responsively to the anchor being inserted in the tissue, in which the disk defines a concavity that faces away from the tissue.

[0405] Example 49. The anchor according to example 48, wherein the disk is a bi-stable disk that is transitionable between the first cupped state and the second cupped state.

[0406] Example 50. The anchor according to example 48, wherein the indicator is transitionable to a flattened state responsively to the disk contacting the tissue and becoming sandwiched between the head and the tissue.

[0407] Example 51. The anchor according to any one of examples 35-50, wherein the indicator is a disk positioned at a tissue-facing surface of the head, and wherein the indicator comprises a radiopaque element that is woven along a surface of the disk.

[0408] Example 52. The anchor according to example 51, wherein the radiopaque element is or comprises at least one of a wire and / or a radiopaque thread.

[0409] Example 53. The anchor according to any one of examples 35-52, wherein the indicator comprises a piezoelectric inclusion.

[0410] Example 54. A system, the system comprising: (i) the anchor according to any one of examples 35-53; and / or (ii) a driver adapted to anchor the tissue-engaging element into tissue of the heart.

[0411] Example 55. The system according to example 54, further including a catheter, wherein the catheter has a distal portion that comprises: (i) a radiopaque proximal marker, (ii) a radiopaque distal marker, and / or (iii) a compressible zone between the proximal marker and the distal marker.

[0412] Example 56. The system according to example 55, wherein the catheter is configured such that, via application and release of an axially-compressive force to the distal portion, the distal portion is reversibly transitionable between: (a) an extended state in which the proximal marker and the distal marker are fluoroscopically distinguishable from each other, and / or (b) a compressed state in which the proximal marker and the distal marker are fluoroscopically indistinguishable from each other.

[0413] Example 57. The system according to any one of examples 54-56, wherein the indicator comprises a piezoelectric inclusion, and wherein the driver is adapted to drive the tissue-engaging element into the tissue until the piezoelectric inclusion presses against a surface of the tissue, the piezoelectric inclusion configured to generate piezoelectricity responsively to the pressing against the tissue.

[0414] Example 58. The system according to any one of examples 54-57, wherein the driver comprises: (i) a handle at a proximal part of the driver, (ii) a shaft extending distally from the handle, (iii) a rod extending from the handle, distally through the shaft, and wherein the system further comprises a sensor, at the proximal part of the driver, adapted to sense movement of the rod with respect to the handle, wherein the driver is adapted to transluminally deliver the anchor to the tissue and drive the tissue-engaging element into the tissue such that the tissue pushes the rod proximally with respect to the head and the handle.

[0415] Example 59. The system according to any one of examples 54-58, wherein the driver comprises a radiopaque portion, adapted to provide an indication of anchoringstrength of the tissue-engaging element within the tissue, by, responsively to a proximal force applied to the driver, stretching axially by a predetermined amount.

[0416] Example 60. A method comprising: (a) transluminally delivering an anchor to a (real or simulated) tissue of a (real or simulated) subject, the anchor having a head, a tissueengaging element extending away from the head to define an anchor axis of the anchor, and an imaging marker coupled to at least one of the head or tissue-engaging element; (b) driving the tissue-engaging element into the tissue such that the imaging marker moves with respect to the head or tissue-engaging element; (c) observing, via an imaging modality, that the imaging marker has moved with respect to the head or tissue-engaging element; and / or (d) responsively to the step of observing, determining that the head or tissue-engaging element is inserted in the tissue.

[0417] Example 61. The method according to example 60, wherein: (a) the imaging marker is a disk, and / or (b) driving the tissue-engaging element into the tissue comprises driving the tissue-engaging element into the tissue while the disk extends around tissueengaging element, such that as the tissue-engaging element is driven into tissue, the disk gets progressively closer to head.

[0418] Example 62. The method according to example 60, wherein: (a) observing that the imaging marker has moved with respect to the head comprises observing that the disk cups around the head, and / or (b) determining that the head is submerged in the tissue comprises determining that the head is submerged in the tissue, responsively to observing that the disk cups around the head.

[0419] Example 63. A method comprising: (a) transluminally delivering an anchor to a (real or simulated) tissue of a (real or simulated) subject, the anchor having a head, a tissueengaging element extending away from the head to define an anchor axis of the anchor, and an imaging marker coupled to the head; (b) screwing the tissue-engaging element into the tissue such that the imaging marker moves with respect to the head; (c) observing, via an imaging modality, that the imaging marker has moved with respect to the head; and / or (d) responsively to the step of observing, partially unscrewing the tissue-engaging element from the tissue.

[0420] Example 64. A method comprising: (a) using a driver that includes a handle, a shaft, and a drivehead, transluminally delivering an anchor to a (real or simulated) tissue of a (real or simulated) subject while a head of the anchor is reversibly engaged by thedrivehead, and a rod extends, from the handle, distally through the shaft and the head, (b) driving a tissue-engaging element of the anchor into the tissue such that the tissue pushes the rod proximally with respect to the head and the handle, and / or (c) responsively to movement of the rod proximally with respect to the handle, identifying a depth to which the tissueengaging element is anchored within the tissue.

[0421] Example 65. The method according to example 64, wherein identifying the depth to which the tissue-engaging element is anchored within the tissue comprises identifying the depth to which the tissue-engaging element is anchored within the tissue responsively to imaging the movement of the rod with respect to the head.

[0422] Example 66. The method according to any one of examples 64-65, wherein the method further comprises, subsequently to driving the tissue-engaging element into the tissue, disengaging the driver from the anchor, by pulling the rod proximally.

[0423] Example 67. A system usable and / or for use at a (real or simulated) tissue of a (real or simulated) subject, the system comprising: (i) an anchor defining: (a) a head, and / or (b) a tissue-engaging element extending away from the head to define an anchor axis of the anchor; (ii) a driver comprising: (a) a handle at a proximal part of the driver, (b) a shaft extending distally from the handle, (c) a rod extending from the handle, distally through the shaft, (d) a sensor, at the proximal part of the driver, adapted to sense movement of the rod with respect to the handle, and / or (e) a drivehead coupled to the shaft at a distal part of the driver, and configured to engage the head whereby the rod extends distally through the head, the driver adapted to: (I) transluminally deliver the anchor to the tissue while the head is engaged by the drivehead, and / or (II) drive the tissue-engaging element into the tissue such that the tissue pushes the rod proximally with respect to the head and the handle; and / or (iii) an indicator, operatively coupled to the sensor so as to provide an indication, signal, or readout responsively to the sensor sensing the pushing of the rod proximally with respect to the handle.

[0424] Example 68. The system according to example 67, wherein the indication, signal, or read-out is electronic, mechanical, or both.

[0425] Example 69. The system according to any one of examples 67-68, wherein the tissue-engaging element is a helical tissue-engaging element that defines a helix, and wherein the rod extends within or outside of the helix.

[0426] Example 70. The system according to any one of examples 67-69, wherein the indicator is adapted to provide a continuum of indications as the rod moves proximally with respect to the handle.

[0427] Example 71. The system according to any one of examples 67-70, wherein the shaft is adapted to transfer an anchoring force, from the handle, to the drivehead, in order to drive the tissue-engaging element into the tissue.

[0428] Example 72. The system according to any one of examples 67-71, wherein the indicator is mounted on the handle.

[0429] Example 73. A system for use at a tissue of a subject, the system comprising a driver that comprises: (i) a handle at a proximal part of the driver, (ii) a shaft extending distally from the handle, (iii) a rod extending from the handle, distally through the shaft, and / or (iv) a sensor, at the proximal part of the driver, adapted to sense movement of the rod with respect to the handle.

[0430] Example 74. The system according to example 73, further comprising an indicator, operatively coupled to the sensor so as to provide an indication, signal, or read-out responsively to the sensor sensing the movement of the rod with respect to the handle.

[0431] Example 75. The system according to example 73, further comprising an anchor defining: (i) a head, and / or (ii) a tissue-engaging element extending away from the head to define an anchor axis of the anchor.

[0432] Example 76. The system according to example 75, wherein the driver comprises a drivehead coupled to the shaft at a distal part of the driver, the drivehead configured to engage the head whereby the rod extends distally through the head.

[0433] Example 77. The system according to example 76, wherein the driver is adapted to: (i) transluminally deliver the anchor to the tissue while the head is engaged by the drivehead, and / or (ii) drive the tissue-engaging element into the tissue such that the tissue pushes the rod proximally with respect to the head and the handle.

[0434] Example 78. A method comprising: (a) using a driver that includes a handle, a shaft, and a drivehead, transluminally delivering an anchor to a (real or simulated) tissue of a subject while a head of the anchor is reversibly engaged by the drivehead, the driver comprising a radiopaque portion that stretches responsively to being pulled proximally away from the drivehead, (b) driving a tissue -engaging element of the anchor into the tissue, (c)subsequently pulling the driver proximally while the drivehead remains engaged with the head, (d) imaging the radiopaque portion, and / or (e) responsively to the imaging, determining that the anchor is satisfactorily anchored to the tissue.

[0435] Example 79. The method according to example 78, wherein: (a) the driver further comprises an outer tube that extends coaxially around the shaft, the outer tube being attached to the drivehead, and defining the radiopaque portion, and / or (b) using the driver to transluminally deliver the anchor to the tissue comprises using the driver that comprises the outer tube to transluminally deliver the anchor to the tissue.

[0436] Example 80. The method according to any one of examples 78-79, wherein the radiopaque portion is disposed at a distal part of the driver.

[0437] Example 81. The method according to any one of examples 78-80, wherein the radiopaque portion is formed by cutting slits along a distal part of the driver.

[0438] Example 82. The method according to any one of examples 78-81, wherein the radiopaque portion is a spring.

[0439] Example 83. The method according to any one of examples 78-82, wherein imaging the radiopaque portion comprises fluoroscopically imaging the radiopaque portion.

[0440] Example 84. The method according to any one of examples 78-83, wherein imaging the radiopaque portion comprises imaging the radiopaque portion while the radiopaque portion is disposed within a thorax of the subject.

[0441] Example 85. The method according to example 84, wherein: (i) the tissue is tissue of a heart of the subject, and / or (ii) imaging the radiopaque portion comprises imaging the radiopaque portion while the radiopaque portion is disposed within the heart.

[0442] Example 86. A system usable and / or for use with a tissue anchor, the system comprising: (i) an anchor defining a head, and a tissue-engaging element extending away from the head to define an anchor axis of the anchor; and / or (ii) a driver comprising: (a) a handle, (b) a shaft, (c) a drivehead at a distal end of the shaft, the driver adapted to anchor the tissue-engaging element into tissue of a subject while the drivehead is reversibly engaged with the anchor, and / or (d) a radiopaque portion, adapted to provide an indication of anchoring strength of the tissue-engaging element within the tissue, by, while the drivehead remains engaged with the head, responsively to a proximal force applied to the driver, stretching axially by a predetermined amount.

[0443] Example 87. The system according to example 86, wherein the radiopaque portion is a zone on the driver that has reduced tensile strength.

[0444] Example 88. The system according to any one of examples 86-87, wherein: (i) the radiopaque portion has a diameter, and / or (ii) the radiopaque portion is adapted to, responsively to the proximal force, stretch axially while substantially retaining the diameter.

[0445] Example 89. The system according to any one of examples 86-88, wherein the driver further comprises an outer tube that extends coaxially around the shaft, the outer tube being attached to the drivehead, and defining the radiopaque portion, and / or the radiopaque portion is adapted to, responsively to a proximal force applied to the outer tube, stretch axially by the predetermined amount.

[0446] Example 90. The system according to any one of examples 86-89, wherein the radiopaque portion defines multiple slits along a distal part of the driver.

[0447] Example 91. The system according to any one of examples 86-90, wherein the radiopaque portion is a spring.

[0448] Example 92. The system according to any one of examples 86-91, wherein the radiopaque portion is disposed at a distal part of the driver.

[0449] Example 93. The system according to example 92, wherein the radiopaque portion is disposed within 10cm of the drivehead.

[0450] Example 94. A system usable and / or for use with a tissue anchor, the system comprising a shaft that comprises a radiopaque portion that is adapted to provide an indication of anchoring strength of the tissue anchor within tissue of a subject, by, responsively to a proximal force applied to the shaft, stretching axially by a predetermined amount.

[0451] Example 95. The system according to example 94, wherein the shaft is an anchor driver.

[0452] Example 96. The system according to example 95, wherein the anchor driver defines a handle, and a driveshaft extending distally from the handle, and wherein the driver is adapted to anchor the anchor into the tissue of a subject while reversibly engaged with the anchor.

[0453] Example 97. The system according to any one of examples 94-96, further comprising the anchor, the anchor defining a head, and a tissue-engaging element extending away from the head to define an anchor axis of the anchor.

[0454] Example 98. A system for use at a (real or simulated) tissue of a heart, the system comprising: (i) an anchor defining a head, and a tissue-engaging element extending away from the head to define an anchor axis of the anchor; (ii) a driver comprising: (a) a shaft, and / or (b) a drivehead at a distal end of the shaft, the driver adapted to anchor the tissueengaging element into tissue of the heart while the drivehead is engaged with the head; and / or (iii) a catheter, the driver adapted to transluminally deliver the anchor via the catheter to the heart, the catheter having a distal portion that comprises: (I) a radiopaque proximal marker, (II) a radiopaque distal marker, and / or (III) a compressible zone coupling the proximal marker to the distal marker, such that, via application and release of an axially- compressive force to the distal portion, the distal portion is reversibly transitionable between: (a) an extended state in which the proximal marker and the distal marker are fluoroscopically distinguishable from each other, and / or (b) a compressed state in which the proximal marker and the distal marker are fluoroscopically indistinguishable from each other.

[0455] Example 99. The system according to example 98, wherein the distal portion is biased to be in the extended state.

[0456] Example 100. The system according to any one of examples 98-99, wherein the distal marker and the proximal marker are markers of a series of markers, the series of markers being axially positioned along the distal portion and interspaced with compressible zones.

[0457] Example 101. The system according to any one of examples 98-100, wherein in the extended state of the distal portion, the compressible zone spaces the proximal marker and the distal marker away from each other, and / or in the compressed state of the distal portion, the proximal marker contacts the distal marker.

[0458] Example 102. The system according to any one of examples 98-101, wherein in the compressed state of the distal portion, the proximal marker is aligned with the distal marker.

[0459] Example 103. The system according to any one of examples 98-102, wherein in the compressed state of the distal portion, the proximal marker is coaxial with the distal marker.

[0460] Example 104. The system according to any one of examples 98-103, wherein the compressible zone is adapted to collapse responsively to the axially-compressive force in a manner in which the proximal marker nests within the distal marker.

[0461] Example 105. The system according to any one of examples 98-104, wherein the compressible zone is adapted to buckle inwardly responsively to the axially-compressive force.

[0462] Example 106. The system according to any one of examples 98-105, wherein the compressible zone is less rigid than a more proximal part of the catheter, such that the compressible zone collapses responsively to the axially-compressive force.

[0463] Example 107. The system according to any one of examples 98-106, wherein the compressible zone is defined by interconnected struts, the struts adapted to deform responsively to the axially-compressive force.

[0464] Example 108. The system according to any one of examples 98-107, wherein the compressible zone is stent-like, the compressible zone is adapted to compress responsively to the axially-compressive force by foreshortening.

[0465] Example 109. The system according to any one of examples 98-108, wherein the compressible zone is braided, the distal portion transitionable to the compressed state responsively to the axially-compressive force by the braid becoming compressed.

[0466] Example 110. The system according to any one of examples 98-109, wherein the head of the anchor defines a radiopaque anchor-marker.

[0467] Example 111. The system according to example 110, wherein, while the distal portion is in the compressed state, the driver is adapted to anchor the tissue-engaging element to the tissue until the anchor-marker becomes fluoroscopically indistinguishable from the proximal and distal markers.

[0468] Example 112. The system according to any one of examples 98-111, wherein the distal portion is biased to be in the extended state, and wherein, when the distal portion is in the compressed state by being pressed against the tissue, the catheter is releasable such that the distal portion reverts to extended state.

[0469] Example 113. The system according to example 112, wherein the compressible zone is sufficiently weak such that using the driver to pull the anchor proximally while the anchorremains anchored to the tissue transitions the distal portion to its compressed state by the tissue exerting a proximally-directed force against the distal portion.

[0470] Example 114. A method usable and / or for use with (real or simulated) tissue of a (real or simulated) heart, the method comprising: (a) transluminally advancing a catheter towards the heart, the catheter having a distal portion that includes: (i) a radiopaque proximal marker, (ii) a radiopaque distal marker, and / or (iii) a compressible zone coupling the proximal marker to the distal marker; (b) fluoroscopically identifying the proximal marker and the distal marker within the heart; (c) subsequently, pressing the distal portion against the tissue such that the compressible zone compresses and the proximal marker and the distal marker become fluoroscopically indistinguishable from each other; (d) while the proximal marker and the distal marker remain fluoroscopically indistinguishable from each other: (e) driving a tissue-engaging element of an anchor out of the distal portion and into the tissue, and / or (f) determining (i) successful anchoring of the tissue-engaging element in the tissue by determining that a head of the anchor has become fluoroscopically indistinguishable from the proximal marker and the distal marker, versus (ii) unsuccessful anchoring of the tissueengaging element in the tissue by determining that a head of the anchor remains fluoroscopically distinguishable from the proximal marker and the distal marker.

[0471] Example 115. The method according to example 114, wherein: (i) the distal marker and the proximal marker are markers of a series of markers, (ii) the compressible zone is a compressible zone of a series of compressible zones, each marker being axially spaced from its neighboring marker by a respective compressible zone, and / or (iii) pressing the distal portion against the tissue comprises pressing the distal portion against the tissue such that the compressible zones compress and the series of markers become fluoroscopically indistinguishable from each other.

[0472] Example 116. The method according to any one of examples 114-115, wherein pressing the distal portion against the tissue comprises pressing the distal portion against the tissue such that the proximal marker contacts the distal marker.

[0473] Example 117. The method according to any one of examples 114-116, wherein pressing the distal portion against the tissue comprises pressing the distal portion against the tissue such that the proximal marker becomes aligned with the distal marker.

[0474] Example 118. The method according to any one of examples 114-117, wherein pressing the distal portion against the tissue comprises pressing the distal portion against the tissue such that the proximal marker becomes coaxial with the distal marker.

[0475] Example 119. The method according to any one of examples 114-118, wherein pressing the distal portion against the tissue comprises pressing the distal portion against the tissue such that compressible zone collapses in a manner in which the proximal marker nests within the distal marker.

[0476] Example 120. The method according to any one of examples 114-119, wherein pressing the distal portion against the tissue comprises pressing the distal portion against the tissue such that the compressible zone buckles inwardly.

[0477] Example 121. The method according to any one of examples 114-120, wherein the head of the anchor defines a radiopaque anchor-marker and wherein determining successful anchoring of the tissue-engaging element in the tissue by determining that the head of the anchor has become fluoroscopically indistinguishable from the proximal marker and the distal marker comprises determining that the anchor -marker has become fluoroscopically indistinguishable from the proximal marker and the distal marker.

[0478] Example 122. The method according to example 121, wherein, determining successful anchoring of the tissue-engaging element in the tissue further comprises pulling the anchor proximally to determine that (i) the proximal marker, the distal marker, and the anchor-marker all remain fluoroscopically indistinguishable, versus (ii) the anchor-marker becomes fluoroscopically distinguishable from the proximal and distal markers.

[0479] Example 123. The method according to example 122, wherein determining successful anchoring of the tissue-engaging element by pulling the anchor proximally comprises pulling the anchor proximally such that: (a) the anchor-marker transiently becomes fluoroscopically distinguishable from the proximal marker and the distal marker, and / or (b) the anchor-marker returns to being fluoroscopically indistinguishable from the proximal marker and the distal marker.

[0480] Example 124. The method according to any one of examples 114-123, wherein determining successful anchoring of the tissue-engaging element further comprises, subsequently to driving the tissue-engaging element of an anchor out of the distal portion and into the tissue: (a) releasing the catheter such that the proximal marker and the distal marker become fluoroscopically distinguishable from each other, and / or (b) whilefluoroscopically imaging the distal portion, pulling the anchor proximally to determine whether the proximal marker and the distal marker become fluoroscopically indistinguishable.

[0481] Example 125. The method according to example 124, wherein the compressible zone is biased to be in an extended state in which the proximal marker and the distal marker are fluoroscopically distinguishable, and wherein releasing the catheter comprises releasing the catheter such that the catheter reverts to its extended state.

[0482] Example 126. The method according to example 124, wherein: (a) the distal marker and the proximal marker are markers of a series of markers, (b) the compressible zone is a compressible zone of a series of compressible zones, each marker being axially spaced from its neighboring marker by a respective compressible zone, (c) releasing the catheter comprises releasing the catheter such that the series of markers become fluoroscopically distinguishable from each other, and / or (d) determining successful anchoring of the tissueengaging element in the tissue by pulling the anchor proximally comprises determining successful anchoring of the tissue-engaging element in the tissue by pulling the anchor proximally to determine the number of markers of the series that become fluoroscopically indistinguishable from each other.

[0483] Example 127. A catheter usable and / or for use at a (real or simulated) tissue of a subject, the catheter having a distal portion that comprises: (a) a radiopaque proximal marker, (b) a radiopaque distal marker, and / or (c) a compressible zone between the proximal marker and the distal marker, such that, via application and release of an axially-compressive force to the distal portion, the distal portion is reversibly transitionable between: (i) an extended state in which the proximal marker and the distal marker are fluoroscopically distinguishable from each other, and / or (ii) a compressed state in which the proximal marker and the distal marker are fluoroscopically indistinguishable from each other.

[0484] Example 128. The catheter according to example 127, wherein the distal portion is biased to be in the extended state.

[0485] Example 129. The catheter according to any one of examples 127-128, wherein the distal marker and the proximal marker are markers of a series of markers, the series of markers being axially positioned along the distal portion and interspaced with compressible zones.

[0486] Example 130. The catheter according to any one of examples 127-129, wherein: (i) in the extended state of the distal portion, the compressible zone spaces the proximal marker and the distal marker away from each other, and / or (ii) in the compressed state of the distal portion, the proximal marker contacts the distal marker.

[0487] Example 131. The catheter according to any one of examples 127-130, wherein in the compressed state of the distal portion, the proximal marker is aligned with the distal marker.

[0488] Example 132. The catheter according to any one of examples 127-131, wherein in the compressed state of the distal portion, the proximal marker is coaxial with the distal marker.

[0489] Example 133. The catheter according to any one of examples 127-132, wherein the compressible zone is adapted to collapse responsively to the axially-compressive force in a manner in which the proximal marker nests within the distal marker.

[0490] Example 134. The catheter according to any one of examples 127-133, wherein the compressible zone is adapted to buckle inwardly responsively to the axially-compressive force.

[0491] Example 135. The catheter according to any one of examples 127-134, wherein the compressible zone is less rigid than a more proximal part of the catheter, such that the compressible zone collapses responsively to the axially-compressive force.

[0492] Example 136. The catheter according to any one of examples 127-135, wherein the compressible zone is defined by interconnected struts, the struts adapted to deform responsively to the axially-compressive force.

[0493] Example 137. The catheter according to any one of examples 127-136, wherein the compressible zone is stent-like, the compressible zone is adapted to compress responsively to the axially-compressive force by foreshortening.

[0494] Example 138. The catheter according to any one of examples 127-137, wherein the compressible zone is braided, the distal portion transitionable to the compressed state responsively to the axially-compressive force by the braid becoming compressed.

[0495] Example 139. The catheter according to any one of examples 127-138, wherein the distal portion is biased to be in the extended state, and wherein, when the distal portion is inthe compressed state by being pressed against the tissue, the catheter is releasable such that the distal portion reverts to extended state.

[0496] Example 140. A system, the system comprising: (i) the catheter according to any one of examples 127-139; and / or (ii) an anchor defining a head, and a tissue-engaging element extending away from the head.

[0497] Example 141. The system of example 140, further including a driver adapted to anchor the tissue-engaging element into the tissue while engaged with the anchor.

[0498] Example 142. The system according to example 141, wherein the compressible zone is sufficiently weak such that using the driver to pull the anchor proximally while the anchor remains anchored to the tissue transitions the distal portion to its compressed state by the tissue exerting a proximally-directed force against the distal portion.

[0499] Example 143. The system according to any one of examples 141-142, wherein the driver comprises: (i) a handle at a proximal part of the driver, (ii) a shaft extending distally from the handle, (iii) a rod extending from the handle, distally through the shaft, (iv) a sensor, at the proximal part of the driver, adapted to sense movement of the rod with respect to the handle, wherein the driver is adapted to transluminally deliver the anchor to the tissue and drive the tissue-engaging element into the tissue such that the tissue pushes the rod proximally with respect to the head and / or the handle.

[0500] Example 144. The system according to any one of examples 141-143, wherein the driver comprises a radiopaque portion, adapted to provide an indication of anchoring strength of the tissue-engaging element within the tissue, by, responsively to a proximal force applied to the driver, stretching axially by a predetermined amount.

[0501] Example 145. The system according to any one of examples 141-145, wherein the anchor includes an indicator.

[0502] Example 146. The system according to example 145, wherein the indicator comprises an imaging marker visible under fluoroscopy.

[0503] Example 147. The system according to example 146, wherein, while the distal portion is in the compressed state, the driver is adapted to anchor the tissue-engaging element to the tissue until the imaging marker becomes fluoroscopically indistinguishable from the proximal and distal markers.

[0504] Example 148. The system according to any one of examples 145-147, wherein the indicator comprises a piezoelectric inclusion.

[0505] Example 149. The system according to example 148, wherein a driver of the system is adapted to drive the tissue-engaging element into the tissue until the piezoelectric inclusion presses against a surface of the tissue, the piezoelectric inclusion configured to generate piezoelectricity responsively to the pressing against the tissue.

[0506] Example 150. The system according to any of the preceding examples, wherein the anchor is sterilized.

[0507] Example 151. The system according to any of the preceding examples, wherein the indicator is sterilized.

[0508] Example 152. The system according to any of the preceding examples, wherein the catheter is sterilized.

[0509] Example 153. A method according to any of the preceding examples, further comprising sterilizing the anchor.

[0510] Example 154. A method according to any of the preceding examples, further comprising sterilizing a distal part of the driver.

[0511] Example 155. A method according to any of the preceding examples, further comprising sterilizing a distal part of the catheter.

[0512] Some 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.

[0513] 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.

[0514] The present invention is not limited to the examples that have been particularly shown and described hereinabove. Rather, the scope of the present invention includes both combinations 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.

Claims

CLAIMS1. A system for use at a heart of a subject, the system comprising: an anchor comprising: a tissue-engaging element; a head comprising a piezoelectric inclusion; a driver, comprising: a handle at a proximal part of the driver, a shaft extending distally from the handle, and a drivehead coupled to the shaft at a distal part of the driver, the driver adapted to, via engagement between the head and the drivehead: drive the tissue-engaging element into tissue of the heart until the head presses against a surface of the tissue, the piezoelectric inclusion configured to generate piezoelectricity responsively to the pressing of the head against the tissue; and conduct the piezoelectricity from the head to the proximal part of the driver; and a sensor, adapted to sense the conducted piezoelectricity.

2. The system according to claim 1, wherein the head comprises: an interface, configured to be engaged by the drivehead of the driver; and a disk that comprises the piezoelectric inclusion, the disk positioned with respect to the interface such that the disk becomes pressed against the tissue responsively to anchoring of the anchor into the tissue.

3. The system according to claim 2, wherein the piezoelectric inclusion is a piezoelectric yarn, woven into the disk.

4. The system according to any one of claims 2-3, wherein the disk can comprise and / or be formed from a piezoelectric textile.

5. The system according to any one of claims 2-4, wherein the disk comprises one or more of Polyethylene terephthalate (PET), polymer polyvinylidene fluoride (PVDF), aluminum nitride, Barium Titanate, Lithium tantalate, potassium sodium tartrate, potassium niobate, and polypeptide poly(benzyl glutamate) (PBLG).

6. The system according to any one of claims 2-5, wherein the head defines a body, the body defining the interface, and wherein the disk is attached to a tissue-facing surface of the body.

7. The system according to any one of claims 2-6, wherein the disk is threaded onto the tissue-engaging element in a manner in which driving the tissue-engaging element into the tissue causes the disk to get progressively closer to the interface by the disk remaining at a surface of the tissue.

8. The system according to any one of claims 2-6, wherein: the piezoelectric inclusion is a first piezoelectric inclusion, an inner region of the disk comprising the first piezoelectric inclusion, the disk further comprises a second piezoelectric inclusion, an outer region of the disk comprising the second piezoelectric inclusion, and the disk is positioned with respect to the interface such that the inner region of the disk becomes pressed between a tissue-facing surface of the head and the tissue responsively to anchoring of the anchor into the tissue, and the outer region of the disk does not become pressed by the tissue-facing surface.

9. The system according to claim 8, wherein the first piezoelectric inclusion is electrically isolated from the second piezoelectric inclusion.

10. The system according to claim 8, wherein the disk defines a band in between the inner region and the outer region, the band comprised of a non-piezoelectric material.

11. The system according to any one of claims 1-10, wherein the piezoelectric inclusion is a piezoelectric crystal.

12. The system according to any one of claims 1-11, wherein the piezoelectric inclusion comprises a ceramic, polymeric, natural, or organic material.

13. The system according to any one of claims 1-12, wherein the system is configured to, responsively to the sensed piezoelectricity, provide an indication of contact between the head and the tissue surface.

14. The system according to any one of claims 1-13, wherein: the piezoelectric inclusion is disposed at a tissue-facing surface of the head, andthe driver is adapted to drive the tissue-engaging element into the tissue such that the piezoelectric inclusion becomes pressed against a surface of the tissue without penetrating the tissue.

15. The system according to any one of claims 1-14, wherein the head can comprise and / or be formed from a piezoelectrically conductive material, and wherein the sensor is adapted to sense the conducted piezoelectricity via the head.

16. The system according to any one of claims 1-15, wherein the driver is disengageable from the head within the heart.

17. The system according to any one of claims 1-16, wherein: the shaft is adapted to conduct piezoelectricity, and the sensor is adapted to sense the conducted piezoelectricity via the shaft.

18. The system according to any one of claims 1-17, wherein: the driver further comprises a rod, extending through the shaft to a drivehead of the driver, configured to control engagement of the drivehead with the head, the rod being adapted to conduct piezoelectricity, and the sensor is adapted to sense the conducted piezoelectricity via the rod.

19. The system according to any one of claims 1-18, wherein: the driver further comprises a connector, extending through the shaft, the connector being adapted to conduct piezoelectricity, and the sensor is adapted to sense the conducted piezoelectricity via the connector.

20. The system according to claim 19, wherein the connector is a wire.

21. The system according to any one of claims 1-20, further comprising a processor, electrically connected to the sensor, and adapted to responsively to the sensed piezoelectricity, provide an indication of contact between the head and the tissue surface.

22. The system according to claim 21, wherein the processor is adapted to provide an indication of current or voltage of the piezoelectricity sensed by the sensor.

23. The system according to claim 21, wherein the processor is adapted to provide a stop signal upon current or voltage of the piezoelectricity exceeding a predetermined threshold, the stop signal being an indication of anchoring-completeness.

24. The system according to claim 21, wherein: the anchor further comprises a disk that comprises the piezoelectric inclusion, andthe disk is positioned with respect to the head such that an inner region of the disk becomes pressed between a tissue-facing surface of the head and the tissue responsively to anchoring of the anchor into the tissue, and an outer region of the disk does not become pressed by the tissue-facing surface.

25. The system according to claim 24, wherein the processor is adapted to provide (i) the indication of contact between the head and the tissue surface upon detecting a piezoelectric signal from the inner region, and (ii) indicate over-anchoring upon detecting a piezoelectric signal from the outer region.

26. The system according to claim 24, wherein the inner region and the outer region are electrically isolated from each other.

27. The system according to claim 26, wherein a first connector connects the inner region to the processor, and a second connector connects the outer region to the processor, the first connector and the second connector being electrically isolated from each other.

28. The system according to claim 24, wherein the processor is adapted to provide the indication of contact between the head and the tissue surface upon detecting a piezoelectric signal from both the inner region and the outer region.

29. The system according to claim 21, wherein the anchor is disconnectable from the processor subsequently to driving the tissue-engaging element into the tissue, by disengaging the driver from the head.

30. An anchor defining a head and a tissue-engaging element extending away from the head, wherein the anchor further comprises an indicator coupled to at least one of the head or the tissue-engaging element and adapted to move with respect to at least one of the head and the tissue-engaging element responsively to the anchor being inserted in tissue of a subject.

31. A system usable and / or for use at a tissue of a subject, the system comprising: an anchor defining: a head, and a tissue-engaging element extending away from the head to define an anchor axis of the anchor; a driver comprising:a handle at a proximal part of the driver, a shaft extending distally from the handle, a rod extending from the handle, distally through the shaft, a sensor, at the proximal part of the driver, adapted to sense movement of the rod with respect to the handle, and a drivehead coupled to the shaft at a distal part of the driver, and configured to engage the head whereby the rod extends distally through the head, the driver adapted to: transluminally deliver the anchor to the tissue while the head is engaged by the drivehead, and drive the tissue-engaging element into the tissue such that the tissue pushes the rod proximally with respect to the head and the handle; and an indicator, operatively coupled to the sensor so as to provide an indication, signal, or read-out responsively to the sensor sensing the pushing of the rod proximally with respect to the handle.

32. A system for use at a tissue of a heart, the system comprising: an anchor defining a head, and a tissue-engaging element extending away from the head to define an anchor axis of the anchor; a driver comprising: a shaft, and a drivehead at a distal end of the shaft, the driver adapted to anchor the tissueengaging element into tissue of the heart while the drivehead is engaged with the head; and a catheter, the driver adapted to transluminally deliver the anchor via the catheter to the heart, the catheter having a distal portion that comprises: a radiopaque proximal marker, a radiopaque distal marker, and a compressible zone coupling the proximal marker to the distal marker, such that, via application and release of an axially-compressive force to the distal portion, the distal portion is reversibly transitionable between: an extended state in which the proximal marker and the distal marker are fluoroscopically distinguishable from each other, anda compressed state in which the proximal marker and the distal marker are fluoroscopically indistinguishable from each other.

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