Bioelectrical guidance for anchoring

Abstract

The system (500) includes an anchor (32), a delivery tool (510), and a data processing system (521). The delivery tool is configured to deliver the anchor to the subject's heart and is configured to drive the anchor into the cardiac tissue (10). The data processing system is configured to receive a first electrical signal via the delivery tool from the anchor located at the tissue and functioning as an electrode after the delivery tool delivers the anchor to the heart. The data processing system is configured to receive a second electrical signal via the delivery tool from a distal portion of the delivery tool located inside the heart. The data processing system is configured to determine a location of the anchor within the heart in response to both the first and second signals and to provide an output indicative of the location. Other embodiments are also disclosed.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to and the benefit of U.S. Provisional Patent Application No. 63 / 298,199 by Harush et al., filed January 10, 2022, entitled "BIOELECTRICAL GUIDANCE FOR ANCHORING."

[0002] The above applications are incorporated herein by reference.

[0003] Some applications of the present invention relate generally to systems and techniques for implanting an implant into or within a subject's heart. More specifically, some applications of the present invention relate to systems and techniques for implanting an implant into or within a subject's heart while being guided by an electrical signal. [Background technology]

[0004] Dilation of the annulus of a heart valve can occur due to various cardiac diseases, such as heart chamber or valve leakage. An annuloplasty procedure may be required to reshape, reinforce or tighten the annulus. Annuloplasty may be performed by implanting an annuloplasty implant to reshape and / or resize the annulus, e.g., to reduce the size of the annulus.

[0005] Tissue anchors can be used to facilitate implantation of such annuloplasty implants, such as by bonding such implants to cardiac tissue. The anchors may be driven through the implant and into the tissue while holding the implant in place. Alternatively, the anchors may be implanted prior to introduction into the implant, and the implant may then be bonded to the anchors.

[0006] The tissue anchors can also be used in conjunction with other cardiac implants, such as other annulus anchoring implants, to facilitate implantation of those implants. Summary of the Invention [Problem to be solved by the invention]

[0007] In particular, the present disclosure relates to methods and systems for implanting an implant into the heart of a subject (e.g., a human subject) by guidance via electrophysiological signals generated by the heart, e.g., by using anchors of the implant that are intended to function as electrodes inside the heart to detect those electrophysiological signals. [Means for solving the problem]

[0008] Typically, prior to implanting an implant within the heart, a controller (e.g., a surgeon and / or a data processing system such as a computer processor) receives information regarding the desired implantation site of the implant within the heart. The implant is typically attached to the heart via anchors, and it may be important for the implant to achieve its intended purpose that the anchors be anchored accurately according to the surgical plan. For example, in applications where the implant is an annuloplasty implant for implantation around the annulus of a heart valve, it is typically desirable for the anchors of the annuloplasty implant to be anchored into the annulus, e.g., the anchors are driven through the atrial surface of the annulus. Thus, in some applications, it is not desirable for such anchors to be anchored to other tissue, such as the atrial wall located upstream of the valve, or the ventricular wall located downstream of the valve.

[0009] Prior to driving the anchor into tissue, the distal tip of the anchor may be placed against tissue for the purpose of intraoperatively determining whether the anchor is optimally positioned for anchoring. In this position, the anchor is used as an electrode through which a data processing system electrically connected to the anchor can acquire electrical signals generated by the heart. Based on this information, the data processing system provides an indication of the position of the anchor within the heart that an operator (e.g., physician) can use to facilitate optimal anchoring of the anchor.

[0010] The data processing system may be configured to correlate the various electrical signals with corresponding locations of the electrodes within the heart (e.g., different tissues of the heart or different locations along the atrioventricular axis of the heart). For example, a signal obtained from an anchor placed against tissue of the valve annulus may be different than a signal obtained from the same anchor when placed against tissue of the atrium or against tissue of the ventricle. If the data processing system determines that the anchor is properly placed within the heart, the anchor may be driven into the tissue.

[0011] In some applications, the data processing system is electronically coupled to the anchor via an anchor driver that is used to drive the anchor into the tissue. For example, a wire having a connector (e.g., an alligator clip) at an end may extend from the data processing system and may be mechanically and electrically connected (e.g., clipped) to a portion of the conductive shaft of the anchor driver that is positioned outside the subject.

[0012] In some applications, the data processing system also receives an electrical signal (i.e., a second electrical signal) from an additional component of the implantation system (e.g., a delivery tool of the implant and / or an additional component of the implant itself), i.e., in addition to the electrical signal from the anchor (which may be referred to as the first electrical signal). This additional component may be considered a second electrode, and the anchor is referred to as the first electrode. From the first and second signals, the data processing system may derive an improved signal, which may be improved (e.g., may be improved to have a better signal-to-noise ratio) compared to the first signal alone.

[0013] In some such applications, the second electrode is not in contact with tissue at the time of signal detection, e.g., the second electrode may be suspended within the bloodstream within the heart, e.g., the implant system may be configured to facilitate such placement.

[0014] A reference electrode is typically placed on the patient at a location spaced from the heart, e.g., on the subject's skin, for the purposes of acquiring each of the first and second signals.

[0015] The above-mentioned applications may be implemented during an annuloplasty procedure in which an annuloplasty implant is implanted around the annulus of a heart valve to reduce valve regurgitation. The annuloplasty implant may include a retraction mechanism, such as a spool, to retract the tether of the implant after it is implanted around the annulus to reduce the valve's circumferential length. In such applications, the retraction mechanism may function as a second electrode. A guide member may extend proximally from the retraction mechanism to the exterior of the subject, which may facilitate, for example, the forward drive of an adjustment tool along the guide member to drive the retraction mechanism. The guide member may function as a conductor from the retraction mechanism (which functions as the second electrode). A second wire having a second connector at its end may extend from the data processing system and may be mechanically and electrically connected (e.g., clipped) to a portion of the guide member located outside the subject.

[0016] Additionally or alternatively, the above-described applications may be implemented by having a second electrode disposed at the distal end portion of the delivery catheter of the delivery tool and by a conductor extending proximally along the delivery catheter to the external portion of the delivery tool, and further, a wire may be mechanically and electrically connected to the conductor.

[0017] Techniques for assessing whether an anchor has been fully driven into cardiac tissue are now described. In some applications, the anchor includes a tissue engaging member configured to be driven into tissue and an anchor head having a tissue-facing surface that contacts the tissue surface after the tissue engaging member has been fully driven into the tissue. The anchor is typically delivered to the heart and driven into the tissue using an anchor driver reversibly coupled to the anchor head.

[0018] Receiving an indication that the anchor head has made direct contact with the tissue surface may provide an indication that anchoring has been successful and / or that anchoring has been completed (e.g., the anchor has been driven into the tissue to a required depth). To determine whether the anchor head is in direct contact with the tissue surface, a tissue-facing electrode disposed at the tissue-facing surface of the anchor head serves as a detection electrode from which an electrical signal is received by a data processing system. Thus, after the tissue-facing surface of the anchor head makes direct contact with the tissue surface, the resulting electrical signal is received by the data processing system, which in response provides feedback that the anchor has been properly implanted into the tissue. The data processing system typically receives these electrical signals via an anchor driver.

[0019] According to some applications, techniques are provided for assessing whether an anchor has been driven into the tissue of the valve annulus. In some applications, after determining that the anchor is in contact with the tissue of the valve annulus, it is advantageous to continuously assess (e.g., using a method similar to that described above) whether the anchor has been properly anchored as the anchor is driven into the tissue. Different tissues of the heart may respond differently to the anchoring process, and thus a data processing system (e.g., a data processing system as described above) may provide an indication of the position and / or location of the anchor within the tissue in response to the anchoring. For example, the electrical signal detected by the anchor typically changes when the tissue engaging member passes through solid tissue. Thus, the technique includes using the anchor to detect electrophysiological signals generated by the heart as the anchor is driven into the tissue by having the anchor act as an electrode within the heart, and determining whether the anchor is driven into the tissue in a desired manner in response to the electrical signal.

[0020] In some applications, one or more of the techniques described herein are augmented by determining the orientation of a distal portion of the delivery system based on electrical sensing, for example by sensing intrinsic or exogenous electrical signals.

[0021] Thus, according to some applications of the invention, there is provided a system for use with a subject's heart, the system including an anchor, a delivery tool, and a data processing system. The delivery tool may be configured to deliver the anchor to the subject's heart and / or drive the anchor into tissue of the heart. The data processing system is configured to: and configured to receive a first electrical signal via the delivery tool from an anchor located at the tissue and functioning as an electrode; and configured to receive a second electrical signal, via the delivery tool, from a distal portion of the delivery tool located inside the heart; and / or configured to determine a position of the anchor within the heart in response to both the first and second signals. It may be configured to provide a position-indicated output.

[0022] In some applications, the data processing system is configured to receive the first electrical signal before the delivery tool drives the anchor into tissue, configured to receive the second electrical signal, configured to determine the position, and / or configured to provide an output.

[0023] In some applications, the anchor is referred to as a helical anchor.

[0024] In some applications, The data processing system, prior to receiving the first signal, configured to receive a first initial electrical signal via the delivery tool from an anchor located within the subject but spaced apart from the tissue, the anchor functioning as an electrode; configured to receive a second initial electrical signal via the delivery tool from a distal portion of the delivery tool located within the subject but spaced apart from the tissue; configured to assign the subject to a category in response to the first initial electrical signal and the second initial electrical signal; and / or The data processing signal is configured to determine a location in response to the first electrical signal, the second electrical signal, and the category.

[0025] For some applications, the data processing system is configured to receive the first initial electrical signal and the second initial electrical signal before the delivery tool delivers the anchor to the heart.

[0026] In some applications, the output being indicative of a position and orientation of the anchor within the heart; and / or The data processing system is responsive to both the first signal and the second signal: and / or further configured to determine an orientation of the anchor within the heart. It is further configured to provide an output indicative of the position and orientation of the anchor within the heart.

[0027] In some applications, The orientation is the orientation of the anchor relative to the atrioventricular axis of the heart; The output may be indicative of position and orientation relative to the atrioventricular axis; and / or The data processing system is responsive to both the first signal and the second signal: and / or configured to determine an orientation of the anchor relative to an atrioventricular axis; The device is configured to provide an output indicating the position and orientation of the anchor relative to the atrioventricular axis.

[0028] In some applications, The orientation is the orientation of the anchor relative to the tissue plane of the heart; The output may be indicative of position and orientation relative to a tissue plane; and / or The data processing system is responsive to both the first signal and the second signal: configured to determine an orientation of the anchor relative to the tissue plane; and / or The device is configured to provide an output indicating the position and orientation of the anchor relative to the tissue plane.

[0029] In some applications, the heart having atria, ventricles, and valves located between the atria and the ventricles, the valves having annulus, the heart defining an atrioventricular axis extending from the atria to the ventricles; The position of the anchor is the position of the anchor along the atrioventricular axis; the data processing system is configured to determine a position of the anchor along the atrioventricular axis in response to both the first signal and the second signal after the delivery tool delivers the anchor to the heart and before the delivery tool drives the anchor into the tissue; The output indicates a position of the anchor along the atrioventricular axis. The data processing system is configured to provide an output indicative of the position of the anchor along the atrioventricular axis.

[0030] In some applications, the data processing system may: configured to simultaneously receive a first signal and a second signal; The device is configured to determine a location of the anchor within the heart in response to the simultaneously received first and second signals.

[0031] For some applications, the data processing system is configured to determine a location of the anchor within the heart by determining a difference between the first signal and the second signal.

[0032] In some applications, the data processing system, after providing an output indicative of the position of the anchor within the heart and as the anchor is driven into the tissue, configured to determine a response of the tissue to the anchoring in response to at least one signal selected from the group consisting of the first signal and the second signal; In response to the determined response, the device is configured to provide an output indicating at least one of: (i) the depth of the anchor within the tissue; and (ii) the location of the anchor within the subject's heart.

[0033] In some applications, the anchor has a tissue engaging member and a head, and the data processing system provides an output indicative of a position of the anchor within the heart and as the anchor is driven into the tissue. configured to determine a response of the tissue to the anchoring in response to both the first signal and the second signal; configured to receive a head contact signal from the head of the anchor indicating contact of the head of the anchor with tissue; The apparatus is configured to determine an attack angle of the anchor relative to tissue in response to (i) the determined response and (ii) the head contact signal.

[0034] In some applications, the delivery tool includes a driver reversibly engageable with the anchor and configured to engage the anchor and drive the anchor into tissue; The data processing system is configured to receive a first signal through a driver.

[0035] In some applications, the driver is capable of disengaging from the anchor inside the heart.

[0036] In some applications, The driver is a tip reversibly engageable with the anchor; a shaft extending from a proximal end to a distal end of the driver, the shaft being configured to transmit torque from the proximal end to the distal end of the driver and the shaft being electrically conductive; The data processing system is configured to receive the first signal via the shaft.

[0037] In some applications, The driver is a tip reversibly engageable with the anchor; a shaft extending from a proximal end to a distal end of the driver, the shaft configured to transmit torque therefrom; a rod extending through the shaft to the tip, the rod being configured to control engagement of the tip with the anchor and the rod being electrically conductive; The data processing system is configured to receive the first signal through the rod.

[0038] In some applications, The system further includes an adjustment tool and an annuloplasty implant, the annuloplasty implant comprising: an anchor configured to anchor the implant to tissue; Tether, a contraction mechanism configured, when actuated, to contract the implant; the distal portion of the delivery tool includes a distal portion that is a distal portion of a guide member of the delivery tool and is mechanically connected to the retraction mechanism, the guide member extending proximally from the retraction mechanism and configured to translationally guide the adjustment tool relative to the retraction mechanism after anchoring the implant to the tissue, and the adjustment tool is configured to drive the retraction mechanism; The data processing system is configured to receive a second electrical signal from a distal portion of the guide member mechanically connected to the retraction mechanism after the delivery tool delivers the anchor into the heart and before the delivery tool drives the anchor into the tissue.

[0039] In some applications, the distal portion of the guide member is mechanically and electrically connected to the retraction mechanism, and the data processing system is configured to receive a second electrical signal from the distal portion of the guide member that is mechanically and electrically connected to the retraction mechanism after the delivery tool delivers the anchor into the heart and before the delivery tool drives the anchor into the tissue.

[0040] In some applications, the system further includes a sensing device including a data processing system and a connector, the connector being electrically and mechanically connectable to the proximal portion of the guide member in a manner such that the data processing system is configured to receive a second signal from the distal portion of the guide member via the connector.

[0041] In some applications, the connector is an alligator clip that can be clipped onto the proximal portion of the guide member.

[0042] In some applications, the distal portion of the guide member is mechanically and electrically connected to the retraction mechanism, and the connector is electrically and mechanically connectable to the proximal portion of the guide member in a manner such that the data processing system is configured to receive a second signal from the retraction mechanism via the guide member and the connector.

[0043] In some applications, after the adjustment tool has actuated the retraction mechanism, the guide member can be disconnected from the retraction mechanism within the body, thereby electrically isolating the retraction mechanism located inside the heart from the data processing system.

[0044] For some applications, the anchor defines a distal tip configured to penetrate cardiac tissue, and the data processing system is configured to receive a first signal when the distal tip of the anchor is positioned against the tissue.

[0045] For some applications, the data processing system is configured to receive a first signal when a distal tip of the anchor is positioned against a cardiac tissue surface without penetrating the cardiac tissue.

[0046] For some applications, the system further includes a sleeve configured to be anchored to the tissue by the anchor, and the data processing system is configured to receive a first signal when the sleeve is clamped between the distal tip and the tissue surface.

[0047] For some applications, the data processing system is configured to receive a first signal when the distal tip of the anchor penetrates the heart tissue and is positioned within the heart tissue.

[0048] In some applications, the system further includes a sensing device including a data processing system and a first connector, the first connector being electrically and mechanically connectable to the proximal portion of the delivery tool such that the data processing system is configured to receive a first signal from the anchor via the first connector.

[0049] For some applications, the first connector is an alligator clip that can be clipped onto a proximal portion of the delivery tool.

[0050] In some applications, the sensing device further includes a second connector, the second connector being electrically and mechanically connectable to the proximal portion of the delivery tool, such that the data processing system is configured to receive a second signal from the distal portion of the delivery tool via the second connector.

[0051] For some applications, the second connector is an alligator clip that can be clipped onto the proximal portion of the delivery tool.

[0052] In some applications, the second connector is an electronic snap.

[0053] In some applications, The heart has an atrium, a ventricle, and a valve located between the atrium and the ventricle, the valve having an annulus; The data processing system is configured to determine whether a position of the anchor is located at the valve annulus in response to both the first signal and the second signal after the delivery tool delivers the anchor to the heart and before the delivery tool drives the anchor into the tissue; The output indicates whether the anchor is located at the annulus. The data processing system is configured to provide an output indicating whether the anchor position is at the valve annulus.

[0054] In some applications, The data processing system is further configured to determine whether the location of the anchor is located at an atrium or at a ventricle in response to both the first signal and the second signal after the delivery tool delivers the anchor to the heart and before the delivery tool drives the anchor into the tissue; The output indicates whether the anchor is located at the annulus, at the atrium, or at the ventricle; The data processing system is configured to provide an output indicating whether the location of the anchor is at the valve annulus, at the atrium, or at the ventricle.

[0055] In some applications, the electrode is a first electrode, the anchor functions as the first electrode, The distal portion of the delivery tool includes a second electrode, and the data processing system is configured to receive a second electrical signal from the second electrode.

[0056] In some applications, the second electrode is disposed on a sidewall of the catheter of the delivery tool.

[0057] In some applications, the catheter includes a wire extending from the second electrode along the catheter to an external portion of the catheter; The data processing system is configured to receive a second electrical signal from the second electrode via the wire.

[0058] In some applications, At the external portion of the catheter, the wires are terminated by a connector; The data processing system is electrically and mechanically connectable to the second electrode via the connector.

[0059] For some applications, the data processing system is configured to receive a second signal while the second electrode is suspended in the cardiac blood stream.

[0060] For some applications, the data processing system is configured to receive the second signal when the second electrode is not in contact with cardiac tissue.

[0061] In some applications, the system further includes a reference electrode configured to be placed outside the subject's heart, and the data processing system is configured to determine the position in a manner facilitated by the reference electrode.

[0062] In some applications, the reference electrode is a skin electrode configured to be placed on the skin of the subject.

[0063] According to some applications, there is further provided a system for use with a subject's heart, the system including an anchor, a delivery tool, and a data processing system.

[0064] The delivery tool can be configured to deliver the anchors to the subject's heart and may be configured to drive the anchors into tissue of the heart.

[0065] The data processing system may be configured to be electrically connected to the delivery tool such that the data processing system is adapted to receive (i) a first electrical signal from the anchor via the delivery tool, and / or (ii) a second electrical signal from a distal portion of the delivery tool via the delivery tool.

[0066] When the anchor is coupled to the delivery tool within the heart, the data processing system may be configured to determine a position of the anchor within the heart in response to both the first signal and the second signal, and may be configured to provide an output indicative of the position.

[0067] According to some applications of the present invention, there is further provided a system for use with a subject's heart, the system including an implant, a driver, and a data processing system.

[0068] The implant may include an anchor, a tether coupleable to the anchor, and a retraction mechanism for applying tension to the tether.

[0069] The driver may be configured to deliver the anchor to the subject's heart and may be configured to drive the anchor into tissue of the heart.

[0070] In some applications, the data processing system is configured to receive the first electrical signal before the delivery tool drives the anchor into tissue, configured to receive the second electrical signal, configured to determine the position, and / or configured to provide an output.

[0071] The data processing system may include, after the driver delivers the anchor to the heart and before the driver drives the anchor into the tissue. and may be configured to receive a first electrical signal from an anchor located at the tissue and functioning as a first electrode via a driver providing an electrical connection between the anchor and a data processing system; and configured to receive a second electrical signal via a second electrical connection from a contractile mechanism located within the heart and functioning as a second electrode; and / or configured to determine a position of the anchor within the heart in response to both the first and second signals. It may be configured to provide a position-indicated output.

[0072] In some applications, the data processing system, after providing an output indicative of the position of the anchor within the heart and as the anchor is driven into the tissue, configured to determine a response of the tissue to the anchoring in response to at least one signal selected from the group consisting of the first signal and the second signal; In response to the determined response, the device is configured to provide an output indicating at least one of: (i) the depth of the anchor within the tissue; and (ii) the location of the anchor within the subject's heart.

[0073] In some applications, the anchor has a tissue engaging member and a head, and the data processing system provides an output indicative of a position of the anchor within the heart and as the tissue engaging member is driven into the tissue. configured to determine a response of the tissue to the anchoring in response to both the first signal and the second signal; configured to receive a head contact signal from the head of the anchor indicating contact of the head of the anchor with tissue; The apparatus is configured to determine an attack angle of the anchor relative to tissue in response to (i) the determined response and (ii) the head contact signal.

[0074] In some applications, the heart having atria, ventricles, and valves located between the atria and the ventricles, the valves having annulus, the heart defining an atrioventricular axis extending from the atria to the ventricles; The position of the anchor is the position of the anchor along the atrioventricular axis; the data processing system is configured to determine a position of the anchor along the atrioventricular axis in response to both the first signal and the second signal after the driver delivers the anchor to the heart and before the driver drives the anchor into the tissue; The output indicates a position of the anchor along the atrioventricular axis. The data processing system is configured to provide an output indicative of the position of the anchor along the atrioventricular axis.

[0075] For some applications, the data processing system is configured to receive a second signal when the contractile mechanism is suspended in the bloodstream of the heart.

[0076] For some applications, the data processing system is configured to receive the second signal when the contractile mechanism is not in contact with the tissue of the heart.

[0077] In some applications, the data processing system may: configured to simultaneously receive a first signal and a second signal; The device is configured to determine a location of the anchor within the heart in response to the simultaneously received first and second signals.

[0078] For some applications, the data processing system is configured to determine a location of the anchor within the heart by determining a difference between the first signal and the second signal.

[0079] In some applications, the system further includes a sensing device including a data processing system and a first connector, the first connector being electrically and mechanically connectable to the proximal portion of the driver such that the data processing system is configured to receive a first signal from the anchor via the first connector.

[0080] For some applications, the first connector is an alligator clip that can be clipped onto a proximal portion of the driver.

[0081] In some applications, the first connector is an electronic snap.

[0082] In some applications, the system Adjustment tools and a guide member mechanically connected to the retraction mechanism, the guide member extending proximally from the retraction mechanism and configured to translationally guide the adjustment tool relative to the retraction mechanism after anchoring the implant to the tissue, the adjustment tool configured to drive the retraction mechanism; The data processing system is configured to receive a second electrical signal from the retraction mechanism through the guide member.

[0083] In some applications, the system further includes a sensing device including a data processing system and a connector, the connector being electrically and mechanically connectable to the proximal portion of the guide member in a manner such that the data processing system is configured to receive a second signal from the retraction mechanism via the guide member and the connector.

[0084] In some applications, the connector is an alligator clip that can be clipped onto the proximal portion of the guide member.

[0085] In some applications, after the adjustment tool has actuated the retraction mechanism, the guide member can be disconnected from the retraction mechanism within the body, thereby electrically isolating the retraction mechanism located inside the heart from the data processing system.

[0086] In some applications, the driver is capable of disengaging from the anchor inside the heart.

[0087] In some applications, The driver is a tip reversibly engageable with the anchor; a shaft extending from a proximal end to a distal end of the driver, the shaft being configured to transmit torque from the proximal end to the distal end of the driver and the shaft being electrically conductive; The data processing system is configured to receive the first signal via the shaft.

[0088] In some applications, The driver is a tip reversibly engageable with the anchor; a shaft extending from a proximal end to a distal end of the driver, the shaft configured to transmit torque therefrom; a rod extending through the shaft to the tip, the rod being configured to control engagement of the tip with the anchor and the rod being electrically conductive; The data processing system is configured to receive the first signal through the rod.

[0089] For some applications, the anchor defines a distal tip configured to penetrate cardiac tissue, and the data processing system is configured to receive a first signal when the distal tip of the anchor is positioned against the tissue.

[0090] For some applications, the data processing system is configured to receive a first signal when a distal tip of the anchor is positioned against a cardiac tissue surface without penetrating the cardiac tissue.

[0091] For some applications, the implant further includes a sleeve configured to be anchored to the tissue by the anchor, and the data processing system is configured to receive a first signal when the sleeve is clamped between the distal tip and the tissue surface.

[0092] For some applications, the data processing system is configured to receive a first signal when the distal tip of the anchor penetrates the heart tissue and is positioned within the heart tissue.

[0093] In some applications, The heart has an atrium, a ventricle, and a valve located between the atrium and the ventricle, the valve having an annulus; the data processing system is configured to determine whether a position of the anchor is at the valve annulus in response to both the first signal and the second signal after the driver delivers the anchor to the heart and before the driver drives the anchor into the tissue; The output indicates whether the anchor is located at the annulus. The data processing system is configured to provide an output indicating whether the anchor position is at the valve annulus.

[0094] In some applications, The data processing system is further configured to determine whether a location of the anchor is located at an atrium or at a ventricle in response to both the first signal and the second signal after the driver delivers the anchor to the heart and before the driver drives the anchor into the tissue; The output indicates whether the anchor is located at the annulus, at the atrium, or at the ventricle; The data processing system is configured to provide an output indicating whether the location of the anchor is located at the atrium, at the annulus, or at the ventricle.

[0095] In some applications, the system further includes a reference electrode configured to be placed outside the subject's heart, and the data processing system is configured to determine the position in a manner facilitated by the reference electrode.

[0096] In some applications, the reference electrode is a skin electrode configured to be placed on the skin of the subject.

[0097] According to some applications of the invention, there is further provided a system for use at a heart of a subject, the system may include an anchor, the anchor may include a tissue engaging member and an anchor head having a tissue facing electrode.

[0098] A driver may be configured to be engaged to the anchor head to drive the tissue engaging member into tissue, thereby contacting the tissue facing electrode against a tissue surface of the heart.

[0099] The data processing system may be configured to receive an electrical signal from the tissue facing electrode, via the driver, that is indicative of contact of the tissue facing electrode with tissue, and / or may be configured to provide an indication regarding contact of the anchor head with the tissue surface in response to the electrical signal.

[0100] In some applications, the driver is configured to drive the tissue engaging member into the tissue such that the tissue facing electrode is pressed against the tissue surface without penetrating the tissue.

[0101] In some applications, the anchor can be electrically disconnected from the data processing system by disengaging the driver from the anchor head after the tissue engaging members have been driven into tissue.

[0102] For some applications, the anchor head defines a tissue-facing surface, which functions as a tissue-facing electrode.

[0103] In some applications, the driver is configured to drive the tissue engaging member into tissue such that the tissue facing surface is pressed against the tissue surface without penetrating the tissue.

[0104] For some applications, the anchor head is formed from an electrically conductive material and the data processing system is configured to receive electrical signals from the tissue-facing surface through the anchor head.

[0105] In some applications, the tissue engaging member is electrically isolated from the data processing system.

[0106] In some applications, the tissue engaging member is electrically isolated from the data processing system by electrically isolating the tissue engaging member from the tissue counter electrode.

[0107] In some applications, the anchor head may be an inner core, the tissue engaging member being coupled to the inner core; an outer layer engageable with a driver and functioning as a tissue facing electrode; and an insulating layer that electrically insulates the inner core from the outer layer.

[0108] In some applications, the system further includes a sensing device including a data processing system and a connector, the connector being electrically and mechanically connectable to the proximal portion of the driver such that the data processing system is configured to receive electrical signals from the tissue-facing electrode via the connector.

[0109] In some applications, the connector is an alligator clip that can be clipped onto the proximal portion of the driver.

[0110] In some applications, the connector is an electronic snap.

[0111] In some applications, the driver is disengageable from the anchor head inside the heart.

[0112] In some applications, The driver is a tip reversibly engageable with the anchor head; a shaft extending from a proximal end to a distal end of the driver, the shaft being configured to transmit torque from the proximal end to the distal end of the driver and the shaft being electrically conductive; The data processing system is configured to receive the electrical signals via the shaft.

[0113] In some applications, The driver is a tip reversibly engageable with the anchor head; a shaft extending from a proximal end to a distal end of the driver, the shaft configured to transmit torque therefrom; a rod extending through the shaft to the tip, the rod being configured to control engagement of the tip with the anchor and the rod being electrically conductive; The data processing system is configured to receive the electrical signals via the rod.

[0114] In some applications, the system further includes a reference electrode configured to be placed outside the subject's heart, and the data processing system is configured to determine contact of the anchor head with the tissue surface in a manner facilitated by the reference electrode.

[0115] In some applications, the reference electrode is a skin electrode configured to be placed on the skin of the subject.

[0116] According to some applications of the present invention, there is further provided a system for use at a subject's heart, the system including an anchor, a driver, and a data processing system.

[0117] The anchor may include a tissue engaging member and an anchor head.

[0118] The driver may be configured to drive the tissue engaging member into the tissue of the heart while (i) electrically connected to the electrode at the tissue-facing surface of the anchor head and (ii) electrically insulated from the tissue engaging member.

[0119] The data processing system may be configured to (i) receive electrical signals from the electrodes via the driver when driving the tissue engaging member into the tissue, and / or (ii) provide an indication regarding contact of the anchor head with the tissue surface in response to the electrical signals.

[0120] For some applications, the data processing system is configured to determine an attack angle of the anchor relative to tissue in response to the electrical signal.

[0121] According to some applications of the invention, there is further provided a device for use with (i) an anchor and (ii) a delivery tool including an anchor driver configured to drive the anchor translationally into cardiac tissue of a subject.

[0122] The device may include a first wire electrically and mechanically connectable to a proximal portion of the anchor driver, electrically connecting the device to the anchor via the first wire and further engaging a distal portion of the anchor driver to the anchor, and a second wire electrically and mechanically connectable to a proximal portion of the delivery tool, electrically connecting the device to the distal portion of the delivery tool.

[0123] The data processing system may be configured to (i) determine a position of the anchor within the heart in response to electrical sensing via the first wire and the second wire, and / or (ii) provide an output indicative of the position, with (a) the distal portion of the anchor driver engaged to the anchor and (b) the anchor and the distal portion of the delivery tool positioned within the heart.

[0124] In some applications, the device further includes a third wire electrically and mechanically connected to a reference electrode configured to be placed external to the subject's heart, and the data processing system comprises: configured to receive a first electrical signal between (i) a reference electrode and (ii) an anchor that functions as a first electrode within the heart; configured to receive a second electrical signal between (i) the reference electrode and (ii) the distal portion of the delivery tool; configured to determine a position of the anchor within the heart in response to the first signal and the second signal; A position-indicating output is configured to provide a position-indicating output.

[0125] In some applications, the data processing system comprises: configured to receive an electrical signal between (i) the anchor and (ii) a distal portion of the delivery tool via electrical sensing; configured to determine a position of the anchor within the heart in response to the electrical signal; A position-indicating output is configured to provide a position-indicating output.

[0126] In some applications, the device further includes a third wire electrically and mechanically connected to a reference electrode configured to be placed external to the subject's heart, and the data processing system comprises: configured to receive a first electrical signal between (i) a reference electrode and (ii) an anchor that functions as a first electrode within the heart; configured to receive a second electrical signal between (i) the anchor and (ii) the distal portion of the delivery tool; configured to determine a position of the anchor within the heart in response to the first signal and the second signal; A position-indicating output is configured to provide a position-indicating output.

[0127] According to some applications of the present invention, there is further provided a system for use at a subject's heart, the system including an implant, an anchor, a driver, and a data processing system.

[0128] The implant may be configured to reduce regurgitation in a heart valve.

[0129] The anchor may be for securing the implant to cardiac tissue. The anchor may include a tissue engaging member and an anchor head.

[0130] The driver may be configured to drive the tissue engaging member into the tissue, thereby anchoring the anchor to the tissue.

[0131] The data processing system detects when the tissue engaging member is being driven into the tissue. and / or configured to receive an electrical signal from the anchor via the driver that is indicative of a response of the tissue to the anchoring. The device may be configured to provide an indication regarding the position of the anchor within the subject's heart in response to the electrical signal.

[0132] In some applications, the anchor is referred to as a helical anchor.

[0133] In some applications, The electrical signal is a first electrical signal; The system is a delivery tool including a driver, the delivery tool configured to deliver the anchor to the heart of the subject; a second electrode disposed at a distal portion of the delivery tool; The data processing system detects when the tissue engaging member is being driven into the tissue. configured to receive a second electrical signal from the second electrode; The device is configured to provide an indication of a position of the anchor within the subject's heart in response to the first and second signals.

[0134] In some applications, the heart having atria, ventricles, and valves located between the atria and the ventricles, the valves having annulus, the heart defining an atrioventricular axis extending from the atria to the ventricles; The position of the anchor is the position of the anchor along the atrioventricular axis; The data processing system is configured to determine a position of the anchor along the atrioventricular axis in response to the electrical signals as the tissue engaging member is driven into the tissue; The output indicates a position of the anchor along the atrioventricular axis. The data processing system is configured to provide an output indicative of the position of the anchor along the atrioventricular axis.

[0135] For some applications, the data processing system is further configured to determine an attack angle of the anchor relative to tissue in response to the electrical signal.

[0136] For some applications, the data processing system is further configured to determine a depth of the anchor within the tissue in response to the electrical signal.

[0137] In some applications, the system further includes a sensing device including a data processing system and a connector, the connector being electrically and mechanically connectable to the proximal portion of the driver such that the data processing system is configured to receive electrical signals from the anchor via the connector.

[0138] In some applications, the connector is an alligator clip that can be clipped onto the proximal portion of the driver.

[0139] In some applications, the first connector is an electronic snap.

[0140] In some applications, The electrical signal is a first electrical signal; The system is Adjustment tools and a delivery tool including a driver, the delivery tool configured to deliver the anchor to the heart of the subject; Implants are Tether, a contraction mechanism configured, when actuated, to contract the implant; a distal portion of the retraction mechanism is electrically and mechanically connected to a guide member extending proximally from the retraction mechanism, the guide member configured to translationally guide the adjustment tool relative to the retraction mechanism after anchoring the implant to the tissue, and the adjustment tool configured to drive the retraction mechanism; The data processing system detects when the tissue engaging member is being driven into the tissue. configured to receive a second electrical signal from the retraction mechanism via the guide member; The device is configured to provide an indication of a position of the anchor within the subject's heart in response to the first and second signals.

[0141] In some applications, the system further includes a sensing device including a data processing system and a connector, the connector being electrically and mechanically connectable to the proximal portion of the guide member in a manner such that the data processing system is configured to receive a second signal from the distal portion of the guide member via the connector.

[0142] In some applications, after the adjustment tool has actuated the retraction mechanism, the guide member can be disconnected from the retraction mechanism within the body, thereby electrically isolating the retraction mechanism located inside the heart from the data processing system.

[0143] For some applications, the data processing system is configured to receive the second signal when the contractile mechanism is not in contact with the tissue of the heart.

[0144] For some applications, the data processing system may: configured to simultaneously receive a first signal and a second signal; The device is configured to determine a location of the anchor within the heart in response to the simultaneously received first and second signals.

[0145] In some applications, the driver is capable of disengaging from the anchor inside the heart.

[0146] In some applications, The driver is a tip reversibly engageable with the anchor; a shaft extending from a proximal end to a distal end of the driver, the shaft being configured to transmit torque from the proximal end to the distal end of the driver and the shaft being electrically conductive; The data processing system is configured to receive the electrical signals via the shaft.

[0147] In some applications, The driver is a tip reversibly engageable with the anchor; a shaft extending from a proximal end to a distal end of the driver, the shaft configured to transmit torque therefrom; a rod extending through the shaft to the tip, the rod being configured to control engagement of the tip with the anchor and the rod being electrically conductive; The data processing system is configured to receive the electrical signals via the rod.

[0148] In some applications, The heart has atria, ventricles, and valves located between the atria and the ventricles, the valves having annulus and cusps; The data processing system is configured to determine whether the location of the anchor is at the valve annulus in response to the electrical signal as the tissue engaging member is driven into the tissue; The output indicates whether the anchor is located at the annulus. The data processing system is configured to provide an output indicating whether the anchor position is at the valve annulus.

[0149] In some applications, The data processing system is further configured to determine, in response to the electrical signal as the tissue engaging member is driven into the tissue, whether the location of the anchor is located at the atrium or at the ventricle; The output indicates whether the anchor is located at the annulus, at the atrium, or at the ventricle; The data processing system is configured to provide an output indicating whether the location of the anchor is located at the atrium, at the annulus, at the leaflet, or at the ventricle.

[0150] In some applications, the system further includes a reference electrode configured to be placed outside the subject's heart, and the data processing system is configured to determine the position in a manner facilitated by the reference electrode.

[0151] In some applications, the reference electrode is a skin electrode configured to be placed on the skin of the subject.

[0152] According to some applications of the present invention, there is further provided a system for use at a subject's heart, the system including an implant, an anchor, a driver, and a data processing system.

[0153] The implant may be configured to reduce regurgitation in a heart valve.

[0154] The anchor may be for securing the implant to cardiac tissue. The anchor may include a tissue engaging member and an anchor head.

[0155] The driver may be configured to drive the tissue engaging member into the tissue, thereby anchoring the anchor to the tissue.

[0156] The data processing system detects when the tissue engaging member is being driven into the tissue. and / or configured to receive an electrical signal from the anchor via the driver that is indicative of a response of the tissue to the anchoring. In response to the electrical signal, the tissue engaging member may be configured to provide an indication as to the depth of the tissue engaging member within the tissue.

[0157] In some applications, The electrical signal is a first electrical signal; The data processing system a head contact signal is received from the anchor head via the driver, the head contact signal being an electrical signal indicating contact of the anchor head with the tissue surface; The device is configured to determine an attack angle of the anchor relative to tissue in response to (i) the first electrical signal, and (ii) the head contact signal.

[0158] For some applications, the data processing system is configured to provide an indication regarding the angle of attack in response to the angle of attack.

[0159] In some applications, the data processing system comprises: configured to determine whether the angle of attack is outside a predetermined range of angles of attack; In response, the device is configured to provide an output indicating that the angle of attack is outside a predetermined range of angles of attack.

[0160] According to some applications, there is further provided a system for use with the anchor and for use at the heart of a subject, the system comprising: A delivery tool, a proximal portion and a distal portion drivable in a translational manner forward into the heart; a catheter adapted to translate the anchor into the heart and adapted to drive the anchor into tissue of the heart; a delivery tool further comprising a first electrode and a second electrode at a distal portion; a data processing system electrically connectable to a proximal portion of the delivery tool; Receiving a first electrical signal from a first electrode; receiving a second electrical signal from a second electrode; determining an orientation of the distal portion within the heart in response to both the first signal and the second signal; and providing an orientation indicated output.

[0161] In some applications, the first electrical signal is an intrinsic electrical signal, and the data processing system is configured to receive the intrinsic electrical signal from the first electrode.

[0162] In some applications, the first electrical signal is an exogenous electrical signal, the delivery tool is configured to apply the exogenous electrical signal, and the data processing system is configured to receive the exogenous electrical signal from the first electrode.

[0163] In some applications, the first and second electrodes are axially distributed along the distal portion.

[0164] In some applications, the first and second electrodes are circumferentially distributed about the distal portion.

[0165] In some applications, the delivery tool includes a third electrode at a distal portion; and / or The method further includes receiving a third electrical signal from a third electrode; and / or Determining the orientation includes determining the orientation in response to the first signal, the second signal, and the third signal.

[0166] In some applications, The method is: determining a position of the first electrode within the heart in response to the first signal; and / or determining a position of the second electrode within the heart in response to the second signal; and / or Determining the orientation includes determining the orientation in response to a position of the first electrode and a position of the second electrode.

[0167] In some applications, determining the orientation includes determining the orientation in response to (a) a difference between a position of the first electrode within the heart and a position of the second electrode within the heart, and (b) a distance between (i) a first electrode site where the first electrode is disposed on a distal portion and (ii) a second electrode site where the second electrode is disposed on the distal portion.

[0168] In some applications, the position of the first electrode is a position of the first electrode along an atrioventricular axis of the heart; and / or Determining the orientation includes determining an orientation in response to a position of the first electrode along the chamber and in response to a position of the second electrode.

[0169] In some applications, the position of the second electrode being a position of the second electrode along an atrioventricular axis of the heart; and / or Determining the orientation includes determining an orientation in response to a position of the first electrode along the atrioventricular axis and in response to a position of the second electrode along the atrioventricular axis.

[0170] In some applications, The location of the first electrode is the proximity of the first electrode to an endocardial tissue surface; and / or Determining the orientation includes determining the orientation in response to a proximity of the first electrode to the endocardial tissue surface and in response to a position of the second electrode.

[0171] In some applications, The location of the second electrode is the proximity of the second electrode to an endocardial tissue surface; and / or Determining the orientation includes determining an orientation in response to a proximity of the first electrode to the endocardial tissue surface and in response to a proximity of the second electrode to the endocardial tissue surface.

[0172] In some applications, the orientation being of the distal portion relative to an atrioventricular axis of the heart; The output is indicative of a direction relative to the atrioventricular axis, Determining the orientation includes determining an orientation relative to an atrioventricular axis; and / or Providing the output includes providing an output oriented relative to the atrioventricular axis.

[0173] In some applications, the orientation being of the distal portion relative to a tissue plane of the heart; The output may be indicative of an orientation relative to a tissue plane; and / or The data processing system is responsive to both the first signal and the second signal: configured to determine an orientation relative to a tissue plane; and / or The device is configured to provide an output that indicates an orientation relative to the tissue plane.

[0174] In some applications, the output being indicative of an orientation and position of the distal portion within the heart; The data processing system is responsive to both the first signal and the second signal: and / or further configured to determine a position of the distal portion within the heart. It is further configured to provide an output indicative of an orientation and position of the distal portion within the heart.

[0175] In some applications, receiving a first electrical signal from a first electrode disposed at a distal portion of the delivery tool located within the subject's heart; receiving a second electrical signal from a second electrode disposed at a distal portion of the delivery tool located within the heart; determining an orientation of the distal portion within the heart in response to both the first and second signals; and / or Provides oriented output.

[0176] For some applications, the first electrical signal is an intrinsic electrical signal, and receiving the first electrical signal includes receiving the intrinsic electrical signal.

[0177] In some applications, the first electrical signal is an exogenous electrical signal, and the method further includes applying the exogenous electrical signal, and receiving the first electrical signal includes receiving the exogenous electrical signal.

[0178] In some applications, The method includes, prior to receiving the first signal, receiving a first initial electrical signal from a first electrode positioned within the subject but external to the heart; receiving a second initial electrical signal from a second one disposed external to the heart of the subject; and / or and / or assigning the subject to a category in response to the first initial electrical signal and the second initial electrical signal. Determining the orientation includes determining the orientation in response to the first electrical signal, the second electrical signal, and the category.

[0179] According to some applications, there is further provided a data processing apparatus comprising means for performing the steps of the method.

[0180] According to some applications, a computer program product is further provided that includes instructions that cause the computer to perform the method when the program is executed by a computer.

[0181] There is further provided a computer readable medium having the computer program stored thereon.

[0182] According to some applications of the present invention, there is provided a computer-implemented method, comprising the steps of: receiving a first electrical signal from an anchor in contact with tissue located within the subject's heart; A computer-implemented method is further provided that includes receiving a second electrical signal from a second electrode suspended within the bloodstream of the heart.

[0183] In some applications, the method further includes receiving a third electrical signal from a reference electrode positioned external to the subject's heart.

[0184] In some applications, the method further includes calculating, in response to the first signal and the second signal, a refined signal representative of a difference between the first signal and the second signal.

[0185] In some applications, the improved signal is responsive to the first signal, the second signal, and the third signal.

[0186] The method may further include providing an indication of a position of the anchor within the heart by using the refined signal.

[0187] In some applications, The method includes, prior to receiving any of the first electrical signal, the second electrical signal, and the third electrical signal, and / or receiving an initial signal from one or more of the anchor and the second electrode. and / or further comprising assigning the subject to a category in response to the initial signal. Calculating the improved signal includes calculating the improved signal in response to the first signal, the second signal, the third signal, and the category.

[0188] In some applications, The method includes, prior to receiving any of the first electrical signal, the second electrical signal, and the third electrical signal, and / or receiving an initial signal from one or more of the anchor and the second electrode. and / or further comprising assigning the subject to a category in response to the initial signal. Providing the indication by using the refined signal includes determining the indication in response to the refined signal and the category.

[0189] According to some applications of the invention there is further provided a computer implemented method for use with a subject's heart, the method comprising: receiving a first electrical signal from a tissue engaging member of the anchor in contact with tissue of the subject's heart; receiving a second electrical signal from the anchor head in contact with the cardiac tissue of the subject; providing an indication of a position of the anchor within the heart in response to the first signal; and in response to the second signal, providing an indication regarding contact of the anchor head with the tissue.

[0190] According to some applications of the invention there is further provided a computer implemented method for use with a subject's heart, the method comprising: receiving an electrical signal from a tissue engaging member of the anchor in contact with the cardiac tissue; providing a first output indicative of a position of the anchor within the heart in response to the electrical signal before the tissue engaging member is driven into the tissue and while the tissue engaging member remains in contact with the tissue; continuing to receive an electrical signal as the tissue engaging member is driven into the tissue, the electrical signal indicating a response of the tissue to the anchoring; and providing a second output indicative of a position of the anchor within the heart in response to the electrical signal indicative of a response of the tissue.

[0191] According to some applications, there is further provided a data processing apparatus comprising means for performing the steps of the method.

[0192] According to some applications, a computer program product is further provided that includes instructions that cause the computer to perform the method when the program is executed by a computer.

[0193] According to some applications, there is further provided a computer readable medium having the computer program stored thereon.

[0194] This summary is intended to provide some examples and is not intended to limit the scope of the invention in any way. For example, any feature included in the examples in this summary is not essential to the claims unless expressly recited in the claims. Also, features, components, steps, concepts, etc. described in the examples in this summary and elsewhere in this disclosure can be combined in various manners. Various features and steps described elsewhere in this disclosure may be included in the examples outlined here. [Brief description of the drawings]

[0195] [Figure 1] FIG. 1 is a schematic diagram of a system including an implant, a multi-component delivery tool, and a sensing device according to some applications of the present invention. [Figure 2A] FIG. 1 is a schematic diagram of a system including an implant, a multi-component delivery tool, and a sensing device according to some applications of the present invention. [Figure 2B] FIG. 1 is a schematic diagram of a system including an implant, a multi-component delivery tool, and a sensing device according to some applications of the present invention. [Diagram 3] 3A-3C are schematic diagrams of various outputs provided by the display of the sensing device of FIGS. 1-2B. [Figure 4A] 1-2B , which show experimental data regarding electrical signals received by the sensing device of FIGS. 1-2B . [Figure 4B]1-2B , which show experimental data regarding electrical signals received by the sensing device of FIGS. 1-2B . [Figure 4C] 1-2B , which show experimental data regarding electrical signals received by the sensing device of FIGS. 1-2B . [Figure 4D] 1-2B , which show experimental data regarding electrical signals received by the sensing device of FIGS. 1-2B . [Diagram 5] 5A-5B are schematic diagrams of an exemplary system according to some applications. [Figure 6] 6A-6B are schematic diagrams of various systems according to several applications. [Figure 7] 7A-7B are schematic diagrams of various systems according to several applications. [Figure 8] FIG. 8 is a schematic diagram of various systems according to several applications. [Figure 9] 9A-9B are schematic diagrams of various systems according to several applications. [Figure 10] FIG. 10 shows experimental data received during the time that the anchor penetrates the annulus tissue. [Figure 11] 11 and 12 are schematic diagrams of a distal portion of a delivery tool configured to facilitate orientation within the heart according to some applications. [Figure 12] Same as above. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0196] 1 and 2A-2B, which are schematic diagrams of a system 500 including an implant 222, a multi-component delivery tool 510, and a sensing (and / or procedural assistance) device 520 according to some applications of the present invention. The tool 510 includes one or more rotationally controlled steering catheters configured to deliver the implant to the subject's heart. As described in more detail below, the device 520 includes a data processing system 521 (e.g., a processor) configured to provide instructions regarding the location of the anchors of the implant 222 within the heart upon implantation of the implant.

[0197] In the illustrated example, the implant 222 is an annuloplasty implant, such as an annuloplasty ring structure (e.g., including a flexible sleeve 26 and a contraction mechanism 40), however, it is noted that the techniques disclosed herein may be used mutatis mutandis with other implants. The sleeve 26 may include a woven fabric mesh, such as one including polyethylene terephthalate (e.g., Dacron®). The implant 222 (e.g., its sleeve 26) may be configured to be positioned against only a portion of the circumference of the heart valve annulus 10 (i.e., to form a C-shape), or alternatively, may be configured to be positioned over the entire circumference of the annulus. After being anchored in place, the implant 222 (e.g., its sleeve 26) may be contracted to circumferentially tighten the annulus.

[0198] Sleeve 26 has (a) a tubular sidewall 253 that (i) circumscribes a central longitudinal axis of the sleeve and (ii) defines an interior lumen of sleeve 26 .

[0199] To clamp the annulus 10, the implant 222 includes a flexible elongate contraction member 226 extending along the sleeve 26. The elongate contraction member 226 may include a wire, ribbon, rope, or band, which may include a flexible and / or superelastic material, such as, for example, Nitinol, polyester, stainless steel, or cobalt chrome. In some applications, the wire includes a radiopaque material. In some applications, the contraction member 226 includes a braided polyester suture (e.g., Ticron). In some applications, the contraction member 226 is coated with polytetrafluoroethylene (PTFE). In some applications, the contraction member 226 includes multiple wires intertwined to form a rope structure.

[0200] The implant 222 may further include a retraction mechanism 40 (e.g., an adjustment mechanism) that facilitates retraction of the implant to facilitate adjustment of the circumferential length of the heart valve annulus and leaflets. The retraction mechanism 40 includes a rotatable structure (e.g., a spool, as described later herein) disposed within a housing 44. In some applications of the present invention, the retraction mechanism 40 includes a housing 44. The retraction mechanism 40 may be surrounded by a braided mesh that is bonded (e.g., sutured or otherwise bonded) to the braided mesh of the sleeve 26. In some applications, as shown, the retraction mechanism 40 is bonded to an outer side of the sleeve 26.

[0201] For some applications, the implant 222 (including the retraction mechanism 40) and / or the delivery tool 510 may be as described, with modifications, in one or more of the following documents, each of which is incorporated by reference in its entirety: U.S. Patent Application Publication No. 2014 / 0309661 to Sheps et al. U.S. Patent Application Publication No. 2015 / 0272734 to Sheps et al. U.S. Patent Application Publication No. 2018 / 0049875 to Iflah et al.

[0202] FIG. 1 illustrates the concentric relationships among the components of a delivery tool 510 (exploded view in the left box of FIG. 1). Typically, the delivery tool 510 includes a first outer catheter 12 including a sheath configured to be driven transluminally through a subject's vasculature. In some applications of the invention, the outer catheter 12 includes a sheath configured to be driven forward through the femoral artery toward the atrium 6 of the subject's heart. The tool 510 includes a second or guide catheter 14 including a distal end portion 114 configured to pass through the catheter 12 (i.e., through its first lumen) such that the distal end portion 114 is disposed outside the distal end 102 of the outer catheter 12 and is in a desired spatial orientation within the atrium.

[0203] The distal end portion 112 of the outer catheter 12 is typically steerable, i.e., the distal end portion 112 is deflectable (e.g., by using an extracorporeal member of the tool 510) relative to the immediately proximal portion of the catheter 12. The distal end portion 112 may include a pull ring 511 coupled to two or more pull wires 29a, 29b (as shown in cross section AA in FIG. 1) disposed in corresponding second lumens in the sidewall of the catheter 12. As shown in the exploded view, the guide catheter 14 is configured to be concentrically disposed within the lumen of the catheter 12. The distal end portion 114 of the guide catheter 14 is also typically steerable, i.e., the distal end portion 114 is deflectable (e.g., by using an extracorporeal member of the tool 510) relative to the immediately proximal portion of the catheter 14. The distal end portion 114 may include a pull ring 13 coupled to two or more pull wires 31 a, 31 b (as shown in cross section AA in FIG. 1) disposed within corresponding second lumens in the wall of the catheter 14.

[0204] The guide catheter 14 is steerable to a desired spatial orientation to facilitate driving and implanting the implant into a body cavity of a subject, typically into the atrium upstream of an atrioventricular valve such as the mitral valve or tricuspid valve.

[0205] In applications in which the tool 510 is used to deliver an implant to the mitral valve of a subject, the outer catheter 12 is typically configured to first be driven forward through the subject's vasculature until the distal end 102 of the catheter 12 is disposed within the left atrium. The steerable distal portion of the catheter 12 is then steered to position the distal end 102 of the catheter 12 in a desired spatial orientation within the left atrium.

[0206] In applications in which the tool 510 is used to deliver an implant to the tricuspid valve of a subject, the outer catheter 12 is typically configured to be initially driven forward through the subject's vasculature until the distal end 102 of the catheter 12 is disposed within the right atrium, after which the steerable distal portion of the catheter 12 is steered to position the distal end 102 of the catheter 12 in a desired spatial orientation within the right atrium.

[0207] The steering procedure is typically performed with the aid of imaging modalities such as fluoroscopy, transesophageal echo, and / or echocardiography. Following steering of the distal end portion of catheter 12, guide catheter 14 (containing implant 222) is driven forward through catheter 12 to facilitate delivery and implantation of implant 222 along the mitral valve annulus. During delivery, at least a portion of steerable distal end portion 114 is exposed from distal end 102 of catheter 12 and is therefore intended to be free to be steered toward the mitral valve annulus, as described herein below.

[0208] During delivery of the sleeve 26 to the annulus of the heart valve, the sleeve 26 and the deflation mechanism 40 are disposed within the lumen of the catheter 14 and are typically aligned longitudinally with respect to the longitudinal axis of the catheter 14. The mechanism 40 may be coupled to the sleeve 26 in a manner that allows the mechanism 40 to move (e.g., translate) from being aligned with the longitudinal axis of the catheter 14 (FIG. 1) to being apposed to the sleeve 26 (FIGS. 2A-2B). For example, the deflation mechanism 40 may be coupled to the sleeve 26 via one or more connectors 27, such as sutures, that may provide a flexible and / or articulating connection. In some applications, apposing the deflation mechanism 40 to a portion of the sleeve 26 exposes a drive interface (e.g., drive interface) of the rotating structure, thereby providing access to an interface of the adjustment tool 87, which is then guided towards the deflation mechanism 40 via the guide member 86.

[0209] A flexible longitudinal guide member 86 (e.g., a wire) is coupled to a portion of the deflation mechanism 40 (e.g., a portion of a rotatable structure, as described later in this specification). The guide member 86 has a thickness of 0.35 mm to 0.45 mm, e.g., 0.4 mm. The guide member 86 is configured to facilitate guiding an adjustment tool 87 through the guide member 86 and towards the rotatable structure of the deflation mechanism 40. Typically, the adjustment tool 87 is configured to engage the rotatable structure of the deflation mechanism 40 after implantation of the sleeve 26 along the annulus of the heart valve (e.g., With changes(Sheps et al., U.S. Patent Application Publication No. 2014 / 0309661 and / or Sheps et al., U.S. Patent Application Publication No. 2015 / 0272734, each of which is incorporated herein by reference). Guide member 86 extends from retraction mechanism 40, alongside a portion of distal end portion 114 of guide catheter 14, through opening 15 in guide catheter 14, and into a second lumen in the wall of guide catheter 14. Guide member 86 extends through the second lumen of guide catheter 14 (as shown in cross section AA in FIG. 1 ) and has a proximal end accessible from outside the subject's body. The second lumen in the wall of guide catheter 14 facilitates passage of guide member 86 through tool 510 without interference with other concentrically disposed elongated tubular members passing concentrically through the lumen of guide catheter 14.

[0210] In addition, the system 500 includes a plurality of anchors 32, typically about 5 to about 20 anchors, such as about 10 or about 16 anchors. Each anchor 32 may include a tissue-binding member 60 (e.g., a helical tissue-binding member) and a tool-engaging head 62 (e.g., a non-helical portion) secured to one end of the tissue-binding member. Only one anchor 32 is shown in FIGS. 1 and 2A-2B as being reversibly coupled to the deployment member 38 of the anchor driver 36 of the anchor deployment control member 61. However, each anchor 32 may be reversibly coupled to one or more deployment members 38 of the anchor driver 36. When sleeve 26 is positioned along the annulus of the heart valve, deployment member 61 is configured to drive anchors 32 forward into the lumen of sleeve 26 and to deploy anchors 32 from within sleeve 26 through the wall of sleeve 26 and into cardiac tissue, thereby anchoring sleeve 26 about a portion of the valve annulus. Insertion of anchors 32 into the sleeve and deployment of anchors into cardiac tissue are described in more detail below.

[0211] Typically, although not required, anchors 32 comprise a biocompatible material, such as stainless steel 316LVM. In some applications, anchors 32 comprise Nitinol. In some applications, at least a portion of each anchor 32 is coated with a non-conductive material.

[0212] The deployment operating member 61 includes an anchor driver 36 and a deployment member 38. In some applications, the deployment operating member 61 includes a channel 18.

[0213] The sleeve 26 is typically disposed within the lumen of the guide catheter 14. A force can be applied to the proximal end of the sleeve 26 via a reference force tube 19, the distal end of which is coupled to the proximal end of the sleeve. As shown, an implant decoupling channel 18 is advanceable through the lumen of the reference force tube 19 and through the lumen of the sleeve 26. As shown in the enlarged image of FIG. 1, the distal end 17 of the implant decoupling channel 18 can be placed against an inner wall of the sleeve 26, such as at its distal end. A distal end portion of the channel 18 may include a radiopaque marker 1018. As shown, the tube 19 and the sleeve 26 are longitudinally coaxially disposed with one another.

[0214] In some applications, the channel 18 is steerable.

[0215] Typically, the manipulation member 61 is driven forward within the channel 18. In some applications, the tool 510 includes a plurality of anchor drivers 36 of the manipulation member 61, each driver 36 coupled to a corresponding anchor 32. Each driver 36 is driven forward within the channel 18 to drive the anchor 32 forward and implant the anchor 32 into tissue. After implantation of the anchor 32, the anchor 32 is decoupled from the driver 36, as described herein, and the driver 36 is removed from the channel 18. A subsequent anchor 32 is then driven forward within the channel 18 while coupled to the driver 36 (e.g., a new driver).

[0216] As described below and shown in FIGS. 2A and 2B, a first one of anchors 32 is configured to be deployed through sleeve 26 into cardiac tissue when sleeve 26 is positioned along the valve annulus. Positioning and / or anchoring of anchor 32 within the heart may be facilitated by devices 520 and / or 2520 and / or 3520, as described in further detail herein below. Following deployment of the first anchor, a distal portion of sleeve 26 is slidably driven distally out of a portion of implant decoupling channel 18. To distally decouple sleeve 26 from a portion of an outer surface of channel 18, (1) a proximal force is applied to channel 18 while (2) reference force tube 19 is maintained in place with a distal end of tube 19 providing a reference force to sleeve 26, facilitating freeing a continuous portion of sleeve 26 from around channel 18. Thereafter, as tube 19 and / or catheter 14 are steered to successive positions along the annulus, channel 18 is disposed into successive positions within the lumen of sleeve 26 (as described later herein). As a result, successive portions of sleeve 26 provide a free lumen for driving successive anchors 32 forward and for deploying the anchors through the wall of the sleeve at the successive portions. By thus freeing successive portions of sleeve 26, a distance is created between successive anchors deployed from within the lumen of sleeve 26.

[0217] In some applications, sleeve 26 includes a plurality of radiopaque markers 25 disposed along the sleeve at corresponding longitudinal positions. Markers 25 may provide an indication in an x-ray image (e.g., a fluoroscopic image) as to how much of sleeve 26 has been deployed at any given time during the implantation procedure to enable setting of a desired distance between anchors 32 along sleeve 26. In some applications, the markers include radiopaque ink.

[0218] Typically, at least some (e.g., at least three, e.g., all) of the longitudinal positions are longitudinally spaced apart at regular intervals. Typically, the longitudinal distance between the distal edges of adjacent / consecutive markers and / or the distance between the proximal edges of adjacent markers is set to be equal to the desired distance between adjacent anchors. For example, the markers 25 may include a first marker, a second marker, and a third marker, where the first marker and the second marker are adjacent, and the second marker and the third marker are adjacent, and the distance between the proximal edges and / or the distance between the distal edges of the first marker and the second marker are equal to the distance between the proximal edges and / or the distance between the distal edges of the second marker and the third marker. For example, the distance may be between 3 mm and 15 mm, e.g., 6 mm, and the longitudinal length of each marker may be between 0.1 mm and 14 mm, e.g., 2 mm. (For example, if the distance is 6 mm and the length is 2 mm, then the longitudinal gap between adjacent markers is 4 mm.)

[0219] Each anchor 32 is coupled to a deployment member 38 of an anchor driver 36. The anchor driver 36 typically includes a long, flexible shaft (typically tubular) having at least a flexible distal end portion. The long shaft of the driver 36 extends within the lumen of the channel 18, through the tool 510, toward the proximal end of the proximal handle portion 101 of the tool 510. The tube of the anchor driver 36 provides a lumen through which an elongated rod 130 is slidably driven forward. The rod 130 facilitates locking and unlocking the anchor 32 relative to the deployment member 38. As shown in cross section E-E in FIG. 1, the proximal end of the rod 130 is coupled to components of an anchor release mechanism 28 at the proximal end of the tool 510. The mechanism 28 includes a housing 135 and a finger engagement member 131 coupled to the proximal end of the rod 130. Finger engagement member 131 is coupled to housing 135 via spring 133 (section EE in FIG. 1 ). The proximal end of the tube of anchor driver 36 is coupled to housing 135. The physician releases anchor 32 from deployment member 38 when finger engagement member 131 is pulled proximally to drive rod 130 back proximally.

[0220] The proximal handle portion 101 is supported by a stand having support legs 91 and a handle slide track 90. ​​The handle portion 101 includes an outer catheter handle 22, a guide catheter handle 24, an implant manipulation handle 126, and an anchor release mechanism 28. The handle 22 is coupled to a proximal end of the outer catheter 12. The handle 24 is coupled to a proximal portion of the guide catheter 14. The handle 126 is coupled to a proximal portion of the reference force tube 19, and linear actuation of the handle 126 relative to the handle 24 drives the reference force tube 19 (and thus typically the implant 222) through the catheter 14. As described above, the housing 135 of the anchor release mechanism 28 is coupled to a proximal portion of the tube of the anchor driver 36. The relative locations of the concentrically arranged components of the tool 510 are shown in exploded view and in sections AA, CC, and DD in FIG. 1.

[0221] The stand supporting the proximal handle portion 101 may be actuated in a distal-proximal direction to control the position of the entire delivery tool 510, in particular to adjust the distance of the distal end 102 of the catheter 12 from the atrial septum. The handle 22 includes a steering knob 210 coupled to steering wires 29a, 29b disposed in respective second lumens in the wall of the outer catheter 12. Rotational actuation of the knob 210 adjusts the tension of the wires 29a, 29b, which applies a force to the tension ring 511 at the distal end portion of the outer catheter 12. Such force steers the distal end portion of the catheter 12 within the atrium of the subject's heart in a first steering plane that is typically parallel to the plane of the valve annulus (e.g., from the atrial septum toward the surrounding wall of the atrium). In some applications of the invention, the distal end portion of the catheter 12 may be pre-configured to face downward toward the valve. In some applications, pulling on the distal end portion of catheter 12 may result in the distal end portion being oriented to point downward toward the valve. In some applications of the present invention, the distal end portion of catheter 12 is not oriented to point downward toward the valve.

[0222] The handle 24 is coupled to the track 90 via a first mount 92. The mount 92 is slidable proximally and distally along the track 90 to control the axial position of the guide catheter 14 relative to the outer catheter 12. The mount 92 is slidable via a control knob 216. For example, the control knob 216 of the mount 92 controls the proximal and distal axial movement of the distal steerable portion of the guide catheter 14 relative to the distal end 102 of the outer catheter 12. The handle 24 includes a control knob 214 coupled to the steering wires 31 a, 31 b disposed in respective second lumens in the wall of the guide catheter 14. Rotational actuation of the knob 214 adjusts the tension of the wires 31 a, 31 b, which applies a force to the tension ring 13 at the distal end portion of the guide catheter 14. Such forces steer the distal end portion of the catheter 14 in a second steering plane within the atrium of the subject's heart, typically downward and toward the annulus of the heart valve. Typically, as described herein below, the distal end portion of the guide catheter 14 is steered in a second plane that is substantially perpendicular to the first plane in which the distal end portion of the outer catheter 12 is steered.

[0223] By combined manipulation of the corresponding distal end portions of catheters 12, 14, sleeve 26 is guided downward toward the valve annulus (e.g., via manipulation of the distal end portion of catheter 14) and along the periphery of the valve annulus (e.g., from the posterior section of the valve toward the anterior section of the valve, or vice versa) via manipulation of the distal end portion of catheter 12.

[0224] In some applications, the handle 22 may be tilted by the operating physician to further adjust the position of the distal end of the catheter 12 .

[0225] The handle 126 is slidably coupled to the track 90 via a second mount 93. The mount 93 is slidable in a proximal-distal direction along the track 90 to control the axial position of the reference force tube 19 and at least the proximal portion of the sleeve 26 relative to the guide catheter 14. In some applications, the mount 93 includes a control knob 95. In some such applications, the control knob reversibly locks the mount 93 to the track 90, thereby reversibly preventing the mount from sliding along the track. Alternatively or additionally, the control knob 95 may be rotationally actuated to slide the mount 93 along the track 90 (e.g., acting like a rack and pinion). In some applications, friction between (i) the reference force tube 19 and (ii) the catheter 14 and / or handle 24 reduces the likelihood of the tube 19 inadvertently sliding through the catheter 14, thereby eliminating the need to lock the mount 93 to the track 90. Considered in conjunction with steering of the distal end portion of guide catheter 14, such actuation of tube 19, and of at least the proximal portion of sleeve 26, drives the proximal portion of sleeve 26 toward a desired portion of the tissue forming the valve annulus upon deployment of anchor 32 from within the lumen of sleeve 26, as described later in this specification.

[0226] As described above, to uncouple sleeve 26 from a portion of the exterior surface of channel 18, (1) channel 18 is pulled proximally while (2) reference force tube 19 is held in place. The proximal end of channel 18 is coupled to knob 94 which adjusts the axial position of channel 18 relative to reference force tube 19 and relative to sleeve 26 in a proximal-distal direction.

[0227] Typically, the handle portion 101 includes a release decision prompting member, such as a latch or button, that is automatically engaged when a given length of the sleeve 26 has been driven forward from the channel 18 (e.g., when the channel 18 is located at a given position relative to the tube 19), typically just before the sleeve 26 is completely disengaged from the channel 18.

[0228] The handle portion 101 (including the handles 22, 24, 126 and the anchor release mechanism 28) has a length L1 of 65 cm to 85 cm, for example 76 cm. Typically, as shown, most of the body portion of the outer catheter handle 22 is disposed at a non-zero angle relative to the longitudinal axis ax1 of the components of the tool 510. The steering mechanism provided by the handle 22 for steering the distal end portion of the catheter 12 is disposed in the portion of the handle 22 disposed at a non-zero angle relative to the axis ax1. The handle 22 includes an in-line tubular portion disposed longitudinally in line along the axis ax1 and coaxially relative to the handles 24, 126 and the release mechanism 28. The in-line tubular portion is shaped to define a lumen for inserting the guide catheter 14 therethrough and then inserting the guide catheter 14 into the lumen of the outer catheter 12. The in-line tubular portion has a length L24 of 7 cm to 11 cm, e.g., 7 cm. Due to such a spatial orientation of the majority of the handle 22, inclined relative to the axis ax1, the overall functional length of the handle portion 101 is reduced.

[0229] To determine intraoperatively whether the anchor 32 is in an optimal location for anchoring prior to driving the anchor into tissue, the anchor 32 is typically placed against tissue at a potential anchoring location, with the anchor 32 functioning as a sensing electrode through which a data processing system 521 electrically connected to the anchor can acquire electrical signals generated by the heart. Based on the detected signal (hereinafter referred to as a "first signal"), the data processing system 521 provides an indication of the location of the anchor 32 within the heart, which an operator (e.g., a physician) can use to facilitate optimal anchoring of the anchor.

[0230] As shown in Figures 2A and 2B, a first wire 524 extending from the data processing system 521 is mechanically and electrically connected to a proximal section of the anchor driver 36 for electrically connecting the data processing system to the anchor 32. For example, as shown in Figures 2A and 2B, a connector 534 located at the end of the wire 524 may be mechanically and electrically connected to an accessible portion of the conductive shaft of the anchor driver 36 located outside the subject. Figures 2A and 2B show an application in which the connector 534 is embodied as an alligator clip 534a, which is clipped onto the shaft of the driver 36. However, it will be understood that the scope of the present disclosure includes the use of other suitable electrical and / or mechanical connector means, such as a discrete snap-fit ​​connector or a threaded connector, located on the proximal portion of the anchor driver 36.

[0231] In applications in which rod 130 is used to facilitate locking and unlocking of anchor 32 to deployment member 38, the rod may itself serve as the electrical connection between anchor 32 and connector 534 by virtue of being electrically conductive and / or having an electrically conductive member extending therethrough or along it. In such applications, the electrical connection between rod 130 and connector 534 may be achieved through a portion of the rod that is exposed at the proximal end of anchor driver 36 (e.g., through a window defined in the anchor driver shaft or in housing 135 or protruding proximally from the housing) or through a portion of the anchor driver shaft or housing that is electrically conductive and provides an electrical connection between the connector and the rod.

[0232] Thus, in this state, anchor 32, when implanted within the heart (eg, of implant 222), can be used as an electrode to detect electrophysiological signals generated by the heart.

[0233] As discussed above, anchor 32 is typically placed against tissue at a potential anchoring location for purposes of data processing system 521 evaluating the suitability of the potential anchoring location within the heart for anchoring the anchor. It should be noted that in this context, the term "placed against" may include (i) placing the anchor in direct contact against a tissue surface at the potential anchoring location, (ii) driving the anchor at least partially into the tissue, or (iii) sandwiching sleeve 26 between the anchor and the tissue (e.g., there is no direct contact between the anchor and the tissue).

[0234] In some applications, the data processing system 521 also receives an electrical signal (i.e., a second electrical signal) from an additional component of the implantation system inside the heart (e.g., from the delivery tool 510 and / or from an additional component of the implant 222 itself), i.e., in addition to the signal from the anchor (which may be referred to as the first electrical signal). For example, this additional component may be a second sensing electrode (e.g., a second sensing electrode for sensing an electrophysiological signal generated by the heart) when the anchor is referred to as the first electrode. From the first and second signals, the data processing system 521 may derive an improved signal, which may be improved (e.g., improved to have a better signal-to-noise ratio) compared to the first signal alone. The improved signal may be used to provide an indication to the operator regarding the position of the anchor 32 inside the heart. Various applications for the second electrode will be described below, and as will be described in more detail below, for example, in some applications, electrode 140 disposed at a distal portion of catheter 14 serves as the second electrode (FIG. 2B), or alternatively, in some applications, contractile member 40 serves as the second electrode (FIG. 2A). Typically, the second electrode does not directly contact tissue when detecting a signal, for example, the second electrode may float in the bloodstream inside the heart and does not contact tissue.

[0235] One or more reference electrodes 536 placed external to the heart (e.g., on the subject's skin, such as on the subject's leg, as shown in Figures 2A-2B) may be connected to the data processing system 521 via a third wire 526 and may facilitate acquisition of the first and / or second signals. For example, the first signal may be a "trace" (e.g., an "ECG lead") between the first (anchor) electrode and the reference electrode 536, the second signal may be a trace between the second electrode and the reference electrode, and an improved signal may be derived (e.g., by the data processing system 521) from the first and second signals (e.g., by subtraction). It will be appreciated that other analyses of the signals acquired via these three electrodes may also be used. Additionally, a "skin-to-skin" signal, which may also be referred to as a "reference" signal, may also be used during the anchoring process. This reference signal may be obtained by placing two electrodes external to the subject's heart (e.g., a first reference electrode placed on the subject's left arm and a second reference electrode placed on the subject's right leg).

[0236] In some applications, rather than the data processing system 521 receiving discrete first and second signals and deriving an improved signal therefrom, the data processing system 521 may receive the improved signal more directly as a trace between a first electrode and a second electrode (e.g., a "bipolar signal") In such applications, the electrical connection between the data processing system 521 and the first electrode may be considered to provide the "first signal" and the electrical connection between the data processing system and the second electrode may be considered to provide the "second signal", although the improved signal is typically the product of the potential differences measured between the two electrodes.

[0237] The data processing system 521 may be configured to determine the location of the anchor within the heart in response to the first signal, the second signal, and / or the refined signal. That is, the data processing system 521 may be configured to correlate the various signals to corresponding locations of the anchor 32 within the heart (e.g., different tissues of the heart or different locations along the atrioventricular axis of the heart). For example, an refined signal indicating that an anchor is positioned against tissue of the valve annulus may differ from an refined signal indicating that the same anchor is positioned against tissue of the atrium 6 and from an refined signal indicating that the same anchor is positioned against tissue of the ventricle 8. If the data processing system determines that the anchor is properly positioned within the heart, the anchor may be driven into the tissue.

[0238] The improved signal obtained by placing two or more electrodes within the heart may advantageously increase the ability of data processing system 521 to identify the location of anchor 32 within the heart as compared to a signal that would be obtained with only one electrode placed within the heart. For example, the improved signal may have an improved signal to noise ratio as compared to applications where only one electrode is placed within the heart.

[0239] 4A-4D show experimental data that indicates that the improved signal is more distinct between locations of anchor 32 within the heart than the first or second signals alone. For example, the experimental data shows that the improved signal is graphically different when the anchor is in contact with atrial tissue (FIG. 4B), when the anchor is in contact with ventricular tissue (FIG. 4C), and when the anchor is in contact with annular tissue (FIG. 4D).

[0240] Before the anchor 32 contacts tissue, the baseline of the improved signal may be approximately zero (FIG. 4A) because both the anchor and the second electrode are floating within the cardiac bloodstream and therefore detect substantially the same electrophysiological signal generated by the heart (e.g., the first and second signals cancel each other out). Thus, compared to a system in which only a single detection electrode is used (e.g., only the first signal), the change in the improved signal when the anchor contacts tissue is more noticeable (e.g., compare FIG. 4A with FIGS. 4B-4D). This change may advantageously provide an indication to the operator that the anchor 32 has contacted tissue. Additionally, in some applications, receiving a substantially zero improved signal may advantageously indicate that the second electrode has (e.g., undesirably) contacted tissue, even though contact between the anchor 32 and tissue has been confirmed by other means (e.g., via imaging).

[0241] Typically, the device 520 (e.g., its data processing system 521) executes a program in which at least one of the first signal, the second signal, and the refined signal serve as inputs and which responsively determines a position of the anchor 32 within the heart. As described above, the program may receive the refined signal directly or may derive the refined signal from the first signal and the second signal (e.g., by subtraction). In some applications, the program determines the position of the anchor 32 in response to only the refined signal. In some applications, the program determines the position of the anchor 32 in response to both the refined signal and the first signal. In some applications, the program determines the position of the anchor 32 in response to both the refined signal and the second signal.

[0242] In some applications, by executing the program, the data processing system 521 determines the position of the anchor 32 along the atrioventricular axis of the heart. In some such applications, the data processing system 521 determines whether the anchor 32 is located at a predefined discrete location (which may be one of multiple predefined discrete locations), such as within the atrium, at the valve annulus, or within the ventricle. Additionally or alternatively, the data processing system may determine whether the anchor is in contact with a distinct type of tissue, such as atrial wall tissue, valve annulus tissue, valve leaflet tissue, or ventricular wall tissue.

[0243] In some applications, artificial intelligence and / or machine learning are employed in constructing the program. For example, constructing the program may be facilitated by the artificial intelligence analyzing data (e.g., a labeled data set) that may include (e.g., the refined signal, the first signal, the second signal, and / or other ECG data obtained from a previously performed procedure). In some applications, the positions output by the program intraoperatively are compared against the actual positions of the anchors (e.g., determined by other means) for purposes of training (e.g., further training) the program.

[0244] Experiments have shown that in at least some applications in which programs are built and / or trained using artificial intelligence and / or machine learning, determining a location in response to both the improved signal and the first signal (e.g., using both signals as inputs) may provide a more accurate determination of the location of anchor 32 compared to using either the first signal or the improved signal as an input but not the other.

[0245] The device 520 typically includes a display 528 for providing an output to an operator indicative of the position of the anchor 32 as determined by a program executed by the data processing system 521. For example, the output may indicate a position along the atrioventricular axis of the heart.

[0246] 3A-3C, the display 528 may provide output as an indication of a discrete position of the anchor 32. For example, the display 528 may indicate that the anchor is contacting tissue in the atrium (FIG. 3A), tissue in the ventricle (FIG. 3B), or tissue in the valve annulus (FIG. 3C).

[0247] In some applications, device 520 is configured to provide an output (e.g., on display 528) as a binary output (e.g., a yes / no output or a go / no-go output) in response to data processing system 521 determining that anchor 32 can be driven into tissue at a candidate anchoring location (e.g., by determining that the anchor is in contact with tissue of the annulus).

[0248] In some applications, device 520 is not used as the primary steering device; instead, device 520 is used to augment steering / guidance provided by other means, such as imaging (e.g., fluoroscopy and / or ultrasound). For example, device 520 may be used to verify the location of an anchor determined via imaging. For example, an operator may perform an implantation procedure guided primarily by imaging, but drive an anchor into tissue only if an output is observed that indicates the anchor is contacting annular tissue, or if there is no warning that the anchor is contacting non-annular tissue.

[0249] In some applications, the operator may reposition anchor 32 within the heart in response to output shown by display 528. For example, Figures 3A-3C may represent a series of steps performed by an operator during implantation of implant 222 within the heart, where anchor 32 is first incorrectly positioned against atrial tissue (Figure 3A), then incorrectly positioned against ventricular tissue (Figure 3B), and finally correctly positioned against valve annulus tissue (Figure 3C).

[0250] In some applications, the data processing system 521 is supplied with the surgical plan and is used to provide an indication to the operator, in response to the refined signals, of whether the anchors have been placed in the heart according to the surgical plan.

[0251] In some applications, the display 528 may alternatively or additionally present a graphical representation of at least one of the first signal, the second signal, and the improved signal (e.g., as illustrated in Figures 4A-4D), which the operator may refer to.

[0252] Alternatively, or in addition to using the display 528 to provide a visual output, the device 520 may provide an output, such as an audio output or a tactile / haptic output, through a different medium.

[0253] 2A illustrates an exemplary method of using the system 500, where the retraction mechanism 40 functions as a second electrode inside the subject's heart. In addition to a first wire 524 connectable to the anchor driver 36, a second wire 522 extends from the data processing system 521 and is mechanically and electrically connected to a proximal section of the guide member 86 for the purpose of electrically connecting the data processing system to the retraction mechanism 40. For example, as shown in FIG. 2A, a connector 532 located at the end of the wire 522 may be mechanically and electrically connected to an accessible portion of the guide member 86. FIG. 2A illustrates an application in which the connector 532 is embodied as an alligator clip 532a and clipped onto the external portion of the guide member 86. In such applications, the guide member 86 is typically electrically conductive (e.g., includes a conductive material such as a metal).

[0254] 2B illustrates a variation of the system 500 in which the retraction mechanism 40 does not function as the second electrode, but rather an additional electrode 140 disposed at a distal portion of the delivery tool 510 functions as the second electrode. FIG. 2B illustrates one such application in which the electrode 140 is exposed at the distal portion of the catheter 14. The electrode 140 may be embedded in or fixed onto an outer wall of the catheter distal portion. A wire (or other conductor) 142 extends proximally from the electrode 140 through the catheter 14 (e.g., through the wall of the catheter or within a lumen of the catheter) to an extracorporeal proximal portion of the catheter (e.g., a handle) where a connector 532 can be connected to the wire. 2B illustrates an application in which wire 142 terminates in electronic snap 148 to which connector 532 (also embodied as electronic snap 532b) is mechanically and electrically connected via a snap fit. It will be appreciated that second electrode 140 may be disposed at a distal portion of any component of delivery tool 510 and / or implant 222, for example, second electrode 140 may be disposed at a distal portion of channel 18 on flexible sleeve 26 or on catheter 12 of the delivery tool.

[0255] 5A-5B are schematic diagrams of an exemplary system 1200 according to some applications. System 1200 includes an implant 1210, a delivery tool 1250 for percutaneously implanting the implant, and a device 520 (or a variation of device 520), although for simplicity, device 520 is not shown in FIGS. 5A-5B. In some applications, system 1200 may be considered a variation of system 500.

[0256] The implant 1210 is typically an annuloplasty implant and includes a plurality of anchors 1220 and a contraction member 1212 (e.g., tethers). Each anchor 1220 typically includes an anchor head 1280 having an eyelet 1240 through which the contraction member 1212 is threaded, and a tissue engaging member 1230 configured to be driven into the tissue of the annulus 10.

[0257] Unlike implant 222 of system 500, implant 1210 does not include a sleeve (e.g., sleeve 26). Rather, an anchor is typically threaded onto constriction member 1212 and driven into the tissue of the annulus to constrict the annulus and reduce valvular regurgitation, and then tension is applied to the constriction member to reduce the circumferential length of the annulus, thereby reducing valvular regurgitation.

[0258] As shown in FIG. 5A, the distal portion of the delivery tool 1250 is driven forward into the subject's heart, typically using a transluminal (e.g., transfemoral) approach, after which the anchor 1220 is anchored about the annulus of the heart valve. The anchor (e.g., eyelet 1240) is typically threaded onto the contraction member prior to the forward drive, thereby positioning the contraction member about the annulus by implanting the anchor about the annulus. Tension is then applied to the contraction member to contract the annulus, thereby reducing valve regurgitation (FIG. 5B). To maintain tension within the contraction member, a first locking bead 1214a is typically driven forward along the contraction member 1212 into the implant 1210 together with and distal to the first anchor 1220a, and a second locking bead 1214b is typically driven forward along the contraction member 1212 into the implant after anchoring the final tissue anchor 1220b to the annulus (FIG. 5B).

[0259] For some applications, the implant 1210 and / or delivery tool 1250 may be as described, with modifications, in one or more of the following documents, each of which is incorporated by reference in its entirety:

[0260] U.S. Patent Application Publication No. 2021 / 0145584 to Kasher et al.

[0261] U.S. Provisional Patent Application No. 63 / 162,443, filed March 17, 2021, by Shafigh et al.

[0262] International Patent Application No. PCT / IB2021 / 058665, filed September 23, 2021, by Halabi et al.

[0263] Similar to the method described above with reference to system 500, device 520 is used to identify whether the candidate anchor location is suitable (e.g., whether the candidate anchor location is actually located on the valve annulus) before driving each anchor 1220 into tissue at the candidate anchor location. As in system 500, the anchor is used as a first electrode, and the anchor driver 1260 used to drive the anchor into tissue may also be used to electrically connect a data processing system 521 (not shown) to the anchor. As in the application shown in FIG. 2B, a second electrode 1140 disposed on a distal portion of the delivery tool 1250 (e.g., a distal portion of the delivery catheter 1252) may be connected to the data processing system 521 via a wire 1142 extending from the electrode and extending proximally along the catheter 1252 (e.g., extending into the wall of the catheter as shown in FIG. 5A or extending into the lumen of the catheter) and further to a proximal portion of the catheter outside the body (e.g., the handle), where the connector 532 can be connected to the wire, with modifications, as described above with reference to FIG. 2B.

[0264] In some applications where the contraction member 1212 is electrically conductive, it may be advantageous to electrically insulate the anchor 1220 from the contraction member, for example, to reduce conduction of electrical signals along the contraction member (e.g., from a previously anchored anchor) to the anchor currently engaged by the driver and to the device 520 electrically connected via the driver to the anchor currently engaged by the driver. For example, the eyelet 1240 may include and / or be coated with an electrically insulating material. However, it has been determined that the data processing system 521 will typically be able to determine the position of the currently engaged anchor even if such insulation is not provided.

[0265] During anchoring of the anchors 1220, a known (e.g., fixed) distance between the second electrode 1140 and each corresponding anchor may advantageously aid in deriving an improved signal. For example, because the distance between the second electrode and each anchored anchor is a fixed distance, the data processing system 521 may not need to recalibrate between each anchor stop of the anchor. It will be appreciated that the applications discussed above with reference to FIG. 2B may provide similar advantages.

[0266] 1-5B. Note that after anchoring, the data processing system 521 is typically electrically disconnected from the anchor due to the driver 36 being mechanically decoupled from the anchor. Thus, after implantation, the anchor remains in the heart but ceases to function as an electrode. In applications where the rod 130 provides electrical conductivity to the driver 36, electrical disconnection may occur upon retraction of the rod to release the anchor from the driver.

[0267] Additionally, after implantation of the implant 222, the second electrode may also be electrically disconnected from the data processing system 521. For example, in applications in which the retraction mechanism 40 functions as the second electrode (e.g., as shown in FIG. 2A), the guide member 86 may be disconnected from the retraction mechanism after actuation of the retraction mechanism.

[0268] In applications in which the second electrode is positioned at a distal portion of the delivery tool 510 (e.g., second electrode 140 as shown in FIG. 2B and second electrode 1140 as shown in FIG. 5A), the second electrode is removed from the heart by withdrawal of the delivery tool from the heart after implantation.

[0269] Reference is now made to Figures 6A-6B, 7A-7B, 8, and 9A-9B, which are schematic diagrams of various systems according to several applications. These systems are configured to provide an indication of successful anchoring of an anchor by determining that the anchor head of the anchor has directly contacted the surface of the tissue 11 to which the anchor is being anchored, and / or an indication that anchoring of the anchor is complete (e.g., the anchor has been driven into the tissue to the required depth). Each system includes an anchor, an anchor driver, and a sensing device including a data processing system (e.g., a processor). The tissue 11 may be tissue of the valve annulus 10, but may alternatively be another cardiac tissue or non-cardiac tissue of the subject.

[0270] To determine direct contact between the anchor head and a tissue surface, a tissue-facing electrode disposed at the tissue-facing surface of the anchor head serves as a detection electrode from which a data processing system of the sensing device receives an electrical signal, e.g., an ECG signal. After the tissue-facing surface of the anchor head makes direct contact with the tissue surface, the sensing device outputs an indication of this contact in response to the received electrical signal. Typically, the electrical signal is conducted to the sensing device via an anchor driver, e.g., with modifications as described above.

[0271] In some applications, the electrical signal detected by the tissue-facing electrode is simply the electrophysiological signal generated by the heart, and thus the tissue-facing electrode functions as a sensing electrode for detecting electrical activity generated by the heart. Additionally or alternatively, an exogenous electrical signal may be provided for this purpose (e.g., via a reference electrode placed external to the subject's heart).

[0272] The anchor includes a tissue engaging member configured to be driven into tissue and an anchor head having a tissue-facing surface that contacts the tissue surface after the tissue engaging member is fully driven into the tissue. The anchor is typically delivered to the heart and driven into the tissue using an anchor driver engaged to the anchor head, e.g., as described above, with modifications.

[0273] Typically, the data processing system responsively determines whether contact exists between the anchor head and the tissue surface by executing a program in which the electrical signals obtained by the tissue-facing electrodes serve as input. In some applications, artificial intelligence and / or machine learning are employed in constructing the program. For example, constructing the program may be facilitated by an artificial intelligence analyzing electrical signal data (e.g., a labeled data set) (e.g., such electrical signals and / or other ECG data obtained from a previously performed procedure). In some applications, the position output by the program during surgery is compared against the actual position of the anchor relative to the tissue surface (e.g., determined by other means) for purposes of training (e.g., further training) the program.

[0274] In some applications, determining contact between the anchor head and tissue may additionally or alternatively determine whether the anchor head has been driven into the tissue at an undesirable angle (e.g., oblique to the plane of the tissue 11) rather than at a substantially perpendicular angle to the tissue (e.g., an angle such that the anchor head is approximately parallel to the tissue).

[0275] In some applications, the data processing system may be configured to determine whether the angle of attack is within a predetermined range of angles of attack, and responsively provide an output (e.g., a warning) if the determination indicates that the angle of attack is outside the predetermined range. Thus, in some applications, the data processing system will only issue a warning to an operator if the angle of attack falls outside the predetermined range.

[0276] In some applications, the data processing system is configured to provide an indication regarding the anchor actuation angle, such as by determining whether the anchor head is parallel to the tissue. In some such applications, the anchor may have multiple tissue-facing electrodes disposed along the tissue-facing surface of the anchor head in a manner that facilitates such functionality. For example, receiving electrical signals from only a subset of the tissue-facing electrodes may indicate that the anchor extends into the tissue at an oblique angle relative to the tissue plane, and thus, only a portion of the tissue-facing surface of the anchor head is in contact with the tissue. Similarly, receiving electrical signals from all of the tissue-facing electrodes may indicate that the anchor extends into the tissue substantially perpendicular to the tissue plane, and thus, substantially all of the tissue-facing surface is in contact with the tissue.

[0277] In some applications, the amount the anchor has been driven into tissue is determined and compared to a data processing system determination and / or indication of contact of the anchor head with the tissue surface. For example, if it is determined that contact of the anchor head with the tissue surface occurred earlier than would be expected from the amount the anchor has been driven into tissue (e.g., for anchors having helical tissue engaging members, expected from the number of turns of the anchor), this may be an indication that the anchor has been driven into tissue at an undesirably shallow angle.

[0278] With regard to the preceding paragraph, the amount the anchor has been driven into the tissue may simply be determined by the operator, such as by counting the number of turns of the anchor driver, or by viewing under fluoroscopy, etc. Alternatively or additionally, the amount the anchor has been driven into the tissue may be determined by a data processing system, such as in response to receiving a signal indicative of the reaction of the tissue to the driving of the tissue engaging member into the tissue, as described above, such as with reference to FIG.

[0279] In some applications, the anchor driver can be locked to the anchor head with the tissue facing electrode electrically connected to the data processing system without electrically connecting the tissue engaging member to the data processing system (i.e., such that the tissue engaging member is electrically isolated from the data processing system), so that, for example, contact between the anchor head and tissue can be distinct from contact between the tissue engaging member and tissue. Various applications in which the tissue engaging member is electrically isolated from the data processing system are described below with respect to Figures 6A-9B.

[0280] 6A-6B show a system 2000a including an anchor 2006 including a tissue engaging member 2002 and an anchor head 2004. The system 2000a also includes a sensing device 2520 including a data processing system 2521 (e.g., a processor), and a display 2528. In some applications, the sensing device 2520 may be considered a variation of the sensing device 520.

[0281] The anchor head 2004 has a tissue-facing surface 2008 that may itself function as a tissue-facing electrode. For example, the anchor driver 2236 may be electrically connected to the tissue-facing surface 2008 such that placing the tissue-facing surface against the surface of tissue 11 establishes an electrical connection between the tissue and the data processing system 2521. In some such applications, the entire anchor head 2004 may be electrically conductive (e.g., constructed from a metallic material and / or coated with a conductive coating) such that the anchor head acts as a conductor between the tissue-facing surface 2008 and the anchor driver 2236 such that electrical signals are transmitted through the anchor head to the data processing system 2521. Thus, in some applications, the tissue-facing surface 2008 may be indistinguishable from other portions of the anchor head.

[0282] In some applications, the tissue engaging member 2002 may be non-conductive such that the data processing system 2521 is in electrical contact with the tissue only when the anchor head 2004 contacts the tissue 11 (e.g., only when the tissue counter electrode contacts the tissue). For example, the tissue engaging member 2002 may be formed from and / or coated with an insulating material.

[0283] 7A-7B show a system 2000b including an anchor 2006' including a tissue engaging member 2002 and an anchor head 2004'. The system 2000b also includes a sensing device 2520, or mutatis mutandis, a variation of the sensing device 2520. The anchor 2006' is typically driven forward and anchored using an anchor driver 2236', which may be considered a variation of the anchor driver described above. The anchor 2006' and driver 2236' facilitate an alternative technique for providing electrical insulation between the tissue engaging member 2002 and the tissue facing electrode. In such applications, the tissue facing electrode is an electrode 2238 that is a component of the anchor driver 2236' and extends distally (e.g., through an opening 2010 in the anchor head 2004') to the tissue facing surface of the anchor head such that contacting the anchor head against tissue 11 also contacts the electrode 2238 against the tissue. In some applications, the opening 2010 is lined with an insulating material 2007 such that the electrode 2238 is electrically isolated from the anchor 2006'. Thus, the anchor driver 2236' is configured to electrically connect the data processing system 2521 to the tissue 11 via the electrode 2238 without electrically connecting the tissue engaging member 2002 to the data processing system.

[0284] Figure 7A shows the electrode 2238 in contact with the tissue 11 such that the display 2528 shows contact between the tissue facing surface 2008 and the tissue 11, thereby providing feedback to the operator that the anchor is fully implanted into the tissue (e.g., the tissue engaging member 2002 is fully embedded into the tissue). The anchor driver 2236' can then be disengaged and withdrawn from the anchor 2006, as shown in Figure 7B, thereby leaving the anchor implanted in the tissue.

[0285] FIG. 8 illustrates a system 2000c including an anchor 2006″ including a tissue engaging member 2002 and an anchor head 2004″. The system 2000c also includes a sensing device 2520, or, mutatis mutandis, a variation of the sensing device 2520. The anchor 2006″ is typically driven forward and anchored using an anchor driver 2236, which may be considered a variation of the anchor driver discussed above. The anchor 2006″ and driver 2236 facilitate an alternative technique for providing electrical insulation between the tissue engaging member 2002 and the tissue facing electrode. In such applications, the anchor driver 2236 is coupled to an outer layer 2004a of the anchor head 2004″, which is electrically conductive and extends to the tissue facing surface 2008 of the anchor head 2004″. The outer layer 2004a functions as a tissue facing electrode (or is electrically connected to a tissue facing electrode) such that electrical signals are received by the data processing system 2521 via an electrical connection between the tissue facing surface of the outer layer and the anchor driver.

[0286] As shown in FIG. 8, the insulating layer 2004b is provided to electrically insulate the inner core 2004c of the anchor head 2004'' from the outer layer 2004a. The core 2004c is the part of the anchor head 2004'' to which the tissue engaging member 2002 is coupled. Thus, the data processing system 2521 receives electrical signals only from the tissue facing surface 2008 (i.e., not from the tissue engaging member). The insulating layer 2004b may facilitate the inner core 2004c and the tissue engaging member 2002 being fabricated from a conductive material (e.g., metal) since any electrical signals conducted through these components will not interfere with electrical signals conducted through the outer layer 2004a. However, in some applications, rather than having a discrete insulating layer and a discrete inner core, the anchor head may be fabricated primarily from an insulating material, but with the outer layer 2004a being conductive.

[0287] 9A-9B show schematic diagrams of a system 3000 including a sensing device 3520 for use with an anchor 3006. In some applications, the sensing device 3520 may be considered a variation of the sensing device 2520 and / or may be considered a variation of the sensing device 520, mutatis mutandis. As shown in FIGS. 9A-9B, in some applications, the anchor 3006 may be similar to (e.g., substantially identical to) the anchor 2006″ (FIG. 8), except as noted. In some applications, the anchor 3006 may be similar to (e.g., substantially identical to) the anchor 2006′ illustrated in FIGS. 7A-7B, e.g., the electrode 2238 may extend through an insulating opening in the anchor. The anchor 3006 is typically driven forward and anchored using an anchor driver 3236, which may be considered a variation of the anchor driver described above.

[0288] The device 3520 typically includes a data processing system 3521 (e.g., a processor), which may combine the functionality of the data processing systems 521, 2521, such that the data processing system 3521 is configured to (i) provide an indication 3501 regarding the position of the anchor within the heart during at least a first phase (FIG. 9A) of the anchoring process of the anchor 3006, and (ii) provide an indication 3502 regarding whether anchoring of the anchor is successful and / or complete (e.g., whether the anchor has been driven into the tissue to the required depth) during at least a second phase (FIG. 9B) of the anchoring process. The device 3520 may be configured to provide this indication via a display 3528, which may be considered a variation of the display 528 and / or the display 2528, or a combination of the displays 528, 2528.

[0289] In such applications, the data processing system 3521 is electrically connected (i) via a first electrical connection 3101 to the tissue engaging member 3002 of the anchor, which serves as an electrode of the anchor used to position the anchor, as described above with reference to Figures 1-5B (e.g., the "first electrode" in these Figures), and additionally (ii) via a second electrical connection 3102 to the tissue facing electrode 3004a of the anchor, which serves as an electrode of the anchor used to determine contact of the anchor head with tissue, as described above with reference to Figure 8. In the illustrated example, electrode 3004a is as described above with reference to electrode 2004a, mutatis mutandis, but may alternatively be as described above with reference to electrode 2238, mutatis mutandis.

[0290] Thus, in such applications, the tissue engaging member 3002 functions as a "positioning electrode" and the electrode at the tissue-facing surface of the anchor head functions as a "head contact electrode."

[0291] In some applications, one or both of the first connection 3101 and the second connection 3102 are provided at least in part by the anchor driver 3236. For example, the first connection 3101 may be provided in part by a wire 3111 electrically connected to the tissue engaging member 3002 (e.g., via the conductive inner core 3004c of the anchor head). Similarly, the second connection 3102 may be provided in part by the shaft of the anchor driver 3236 (e.g., via an electrical connection between the shaft and the outer layer 3004a).

[0292] In some applications, the wire 3111 may additionally function as an actuator that controls the locking / unlocking of the driver 3236 relative to the anchor head 3004. For example, the wire 3111 may perform a similar (e.g., identical) function as the rod 130, as described above. Similarly, the rod 130 may function as the wire 3111, with modifications.

[0293] Thus, as shown in FIG. 9A, during a first phase of anchoring the anchor 3006 within the heart, the tissue engagement member 3002 is positioned against the surface of the tissue 11 such that the data processing system 3521 receives an electrical signal via the first connection 3101. In response to this signal, the data processing system provides an indication of the position of the anchor within the heart (e.g., along the atrioventricular axis of the heart, as described above). When an indication of contact of the annulus 10 against tissue is given, a second phase of the anchoring process can be initiated and the anchor is driven into the tissue (FIG. 9B). During this second phase, the data processing system 3521 provides an indication of whether the anchoring process is complete (i.e., whether the anchor head 3004 is in contact with the tissue 11).

[0294] In some applications, electrical insulation between the electrodes of the anchor head 3004 is provided to electrically isolate received signals so that any signals received through the tissue engaging member 3002 during the second phase of anchoring do not interfere with determining contact between the anchor head and the tissue surface. In some applications, this isolation is provided through an insulating layer 3004b, which may be as described with respect to insulating layer 2004b. Similarly, the wire 3111 may be electrically isolated from the shaft of the anchor driver 3236 and / or from the electrode 3004a (e.g., by extending through an insulating opening in the anchor head 3004 (e.g., a variation of the insulating opening described with reference to FIGS. 7A-7B)).

[0295] It will be appreciated that the first and second phases may be performed sequentially or simultaneously by a single data processing system 3521. Alternatively, two data processing systems (e.g., data processing systems 521, 2521) may be used during the anchoring process, with the first connection 3101 electrically connected to data processing system 521 (for use during the first phase of anchoring) and the second connection 3102 connected to data processing system 2521 (for use during the second phase of anchoring).

[0296] Techniques for assessing whether an anchor is being driven into tissue of the valve annulus are now described for some applications. In some applications, after determining (e.g., using the methods described above) that the anchor is in contact with tissue of the valve annulus, it is advantageous to continuously assess whether the anchor is properly anchored (e.g., into the correct tissue and / or at the desired orientation and / or that the anchor has penetrated the tissue and is not floating in the bloodstream and / or that the anchor has been driven into the tissue to the required depth) as the anchor is being driven into the tissue. For example, the data processing system may continue to receive the first signal, the second signal, and / or the refined signal (described above) and may continuously make a determination in response to one or more of these signals.

[0297] Different tissues in the heart may respond differently to the anchoring process, thereby allowing a data processing system (e.g., a data processing system as described above) to provide indications regarding the position and / or placement of the anchor within the tissue in response to electrical signals detected by the anchor as it is driven into the tissue.

[0298] The electrical signal detected by the anchor may change as the tissue engaging member passes through the solid tissue, and the resulting electrical signal may therefore be indicative of the position of the anchor within the heart. For example, in electrocardiogram testing of a subject during the anchoring process, it has been observed that transient electrocardiogram changes, such as abnormalities such as ectopic beats, premature impulses (e.g., premature ventricular contractions (PVCs) and / or premature atrial contractions (PACs)), typically occur as the tissue anchor is driven into the subject's cardiac tissue. The electrocardiogram changes typically occur as the anchor contacts the tissue or as the anchor is driven into the tissue, or shortly thereafter (e.g., within 5 seconds and / or within 5 heartbeats of the anchor being driven). The PVCs may be initiated by and may be indicative of the penetration of the distal end of the tissue engaging member of the tissue anchor into myocardial tissue (e.g., ventricular tissue) after it has completely passed through the valve annulus. Additionally, the absence of abnormalities (e.g., PVCs) upon anchoring of the tissue anchor may be an indication that the tissue engaging member has not penetrated the myocardial tissue. In some applications, it is advantageous for the distal end of the tissue engaging member to pass completely through the valve annulus.

[0299] Thus, the technique involves detecting electrophysiological signals generated by the heart as the anchors are driven into tissue using the anchors as electrodes, and providing an indication of the position of the anchor within the heart in response to the electrical signals, as will be appreciated, the indication of the anchor's position may be (i) an indication of the anchor's orientation within the heart (e.g., the anchor's angle of attack relative to the tissue into which it is driven), and / or (ii) an indication of the anchor's position along the atrioventricular axis of the heart, and / or (iii) an indication of multiple positions through which the anchor passes as it is driven into tissue (e.g., the depth of the anchor within the valve annulus).

[0300] Figure 10 illustrates experimental data showing that the signal received during the period when the anchor penetrates the tissue of the annulus (time period t2) is distinguishable from the signal received during the period when the anchor is only in contact with the tissue surface of the annulus (time period t1). In this experiment, the anchor was only held in contact with the tissue surface during time period t1, and then driven into the tissue during time period t2. Thus, the signal shown in Figure 10 at time period t1 may generally correspond, mutatis mutandis, to the signal shown in Figure 4D. That is, in some applications, Figure 10 may be considered to be a temporal extension of Figure 4D.

[0301] Due to differences in the electrical response of each tissue of the heart to the anchoring process, if the anchor is inadvertently driven into the heart at a non-optimal location and / or at a non-optimal angle and / or at a non-optimal depth (e.g., other than being introduced from the atrium into the annulus), the electrical signal may differ from that shown in FIG. 10. For example, anchoring into the tissue of the valve leaflets may not result in such a significant change during the anchoring process. Furthermore, other myocardium may respond even differently during the anchoring process (e.g., ventricular tissue may respond with a different characteristic electrical signal), and thus the data processing system may provide an indication of the location of the anchor based on the tissue's response to the anchoring process.

[0302] Typically, the data processing system executes a program that receives as inputs at least one of the first signal, the second signal, and the refined signal (as described above) and responsively determines the position of the anchor as it is driven into the heart.

[0303] In some applications, artificial intelligence and / or machine learning are employed in constructing the program. For example, constructing the program may be facilitated by the artificial intelligence analyzing data (e.g., a labeled data set) that may include (e.g., the refined signal, the first signal, the second signal, and / or other ECG data obtained from a previously performed procedure). In some applications, the positions output by the program intraoperatively are compared against the actual positions of the anchors (e.g., determined by other means) for purposes of training (e.g., further training) the program.

[0304] Reference is now made to Figures 11 and 12, which are schematic illustrations of a distal portion of a delivery tool 4250, 5250 configured to facilitate determining an orientation within the heart according to some applications. Additionally or alternatively, it may be advantageous to determine the orientation (e.g., angular disposition) of the distal portion of the delivery tool within the heart and / or within the heart tissue (e.g., relative to the heart and / or heart tissue) to determine the location of the distal portion of the delivery tool and / or to determine the location of an anchor (e.g., as described above) delivered by the delivery tool. For example, this orientation may control and / or define the angle of attack at which the anchor is driven into the tissue. Such an advantage is illustrated in Figures 11 and 12, in which a distal portion of a delivery tool (e.g., of a catheter 4252, 5252, respectively) is about to drive an anchor 1220 into the annulus 10. In either case, the tip of the anchor 1220 contacts the annulus 10, but optimal anchoring may still depend on the angle of attack at which the anchor is driven into the tissue, as illustrated by the following examples, which may be applied in specific practical cases, but are understood to be non-limiting.

[0305] 11, an attack angle that is too shallow relative to the atrioventricular axis ax2 of the heart may drive the anchor 1220 toward a thinner tissue area than desired (e.g., at the base of the valve leaflets), may possibly penetrate to the other side of the tissue, and / or may provide a relatively weak anchoring effect. Such an attack angle is illustrated by the virtual image of the catheter 4252 designated in parentheses by reference number 4252a that is substantially parallel to the atrioventricular axis ax2. Conversely, an attack angle that is too steep relative to the atrioventricular axis ax2 may drive the anchor 1220 toward the coronary vessel 5, which may damage the anchor, and / or may provide a relatively weak anchoring effect. Such an attack angle is illustrated by the virtual image of the catheter 4252 designated in parentheses by reference number 4252b that is substantially perpendicular to the atrioventricular axis ax2.

[0306] 12, an excessively shallow angle of attack in a first orientation relative to the tissue plane may drive the anchor 1220 toward a thinner tissue region than desired (e.g., at the base of the valve leaflet), possibly penetrating through to the other side of the tissue, and / or providing a relatively weak anchoring effect. Such an angle of attack is illustrated by the virtual image of the catheter 5252, designated in parentheses by reference number 5252a, introduced at an oblique angle from the first orientation (e.g., closer to the atrial wall posterior to the leaflet). Conversely, an excessively shallow angle of attack in a second orientation relative to the tissue plane may drive the anchor 1220 toward the coronary vessel 5, potentially damaging the anchor, and / or providing a relatively weak anchoring effect. Such an attack angle is illustrated by a virtual image of catheter 5252, designated in parentheses by reference numeral 5252b, introduced at an angle oblique to a second orientation (eg, closer to the plane of the valve).

[0307] For each of the delivery tools 4250, 5250, the distal portion of the delivery tool includes a plurality of electrodes. Each of these delivery tools is electrically connectable to a data processing system (e.g., a processor), which may, for example, belong to a system including the data processing system, or may simply be compatible with the data processing system. The data processing system receives signals from each of the plurality of electrodes and, in response to the signals, determines an orientation of the distal portion of the delivery tool and provides an output (e.g., a visual output and / or an audible output) indicative of the orientation. For example, the data processing system may include means, such as hardware and / or software, for performing the method. In some applications, the output is provided via a display, such as those described above. In some applications, the data processing system is a component of a sensing (and / or procedural assistance) device, such as those described above. In some applications, the data processing system is the same data processing system as those described above, for example, a single data processing system (e.g., a single sensing device and / or a single procedural assistance device) performs two or more of the techniques described herein.

[0308] Although the electrodes of the delivery tool 4250, 5250 are shown and described as being disposed on the catheter 4252, 5252 of the delivery tool (e.g., the catheter into which the anchor 1220 is driven), it will be understood that the scope of the disclosure includes electrodes disposed on other components of the delivery tool, including, for example, but not limited to, electrodes disposed on the anchor driver of the delivery tool (i.e., the anchor driver that is engaged to the anchor 1220 and drives the anchor into tissue, such as by applying a torque to the anchor). Further, it will be understood that the scope of the disclosure includes application to the delivery tools and systems described elsewhere herein, and to the features described with respect to the delivery tool 4250, 5250, and to the features described with respect to the system to which the delivery tool 4250, 5250 belongs.

[0309] At the distal portion of the delivery tool 4250, a plurality of electrodes are disposed on the catheter 4252. In the illustrated example, the plurality of electrodes are a first electrode 4140 and a second electrode 4142, although it will be understood that a greater number of electrodes may be used. The electrodes 4140, 4142 may be axially distributed along the distal portion of the delivery tool (e.g., of the catheter). Each of these electrodes may be a ring electrode that surrounds the distal portion of the delivery tool at a corresponding axial location. In the context of other systems, the above-mentioned techniques are for determining the location of an electrode (e.g., an anchor that functions as an electrode) within the heart, for example, along the atrioventricular axis of the heart. Applying such techniques, with modifications, to determine the location of each electrode, the orientation of the distal portion of the delivery tool (e.g., of the catheter) may be determined, for example, as a straight line passing through the respective locations.

[0310] In some applications, the orientation determined by the data processing system is an orientation relative to the atrioventricular axis ax2. At least one of the determined positions may be a position along the atrioventricular axis ax2 of the heart. In the illustrated example, a position p1 of the first electrode 4140 along the atrioventricular axis ax2 is determined, and a position p2 of the second electrode along the atrioventricular axis is also determined. In response to the positions p1, p2 (e.g., in response to a difference (e.g., distance) therebetween), the data processing system may determine an orientation of a distal portion of the delivery tool 4250 (e.g., of the catheter 4252) relative to the atrioventricular axis ax2. For example, this determination may be made (a) in response to a determined difference between the positions of each electrode within the heart, and (b) in response to a known / predetermined distance between (i) a first electrode site where the electrode 4140 is located on a distal portion of the delivery tool, and (ii) a second electrode site where the electrode 4142 is located on a distal portion of the delivery tool. The greater the determined p1-p2 distance, the more shallow the orientation may be indicated (e.g., it may be determined that it is indicated) relative to the atrioventricular axis ax2.

[0311] At the distal portion of the delivery tool 5250, multiple electrodes are disposed on the catheter 5252. In the illustrated example, the multiple electrodes are a first electrode 5140, a second electrode 5142, and a third electrode 5144, although it will be understood that two electrodes, four electrodes, or more electrodes may be used. The electrodes 5140, 5142, 51414 may be circumferentially distributed around the distal portion of the delivery tool (e.g., the catheter). Each of the electrodes may be disposed at the same axial location along the distal portion of the catheter, for example, the electrodes may be arranged in an annular array.

[0312] In some applications, the orientation determined by the data processing system is an orientation relative to the tissue plane into which the anchor 1220 is driven. A corresponding signal from each of the electrodes 5140, 5142, 5414 is received by the data processing system. In response to the signals, the data processing system may determine an orientation of a distal portion of the delivery tool 5250 (e.g., of the catheter 5252) relative to the tissue plane. At least one of the signals may be indicative of the proximity of the corresponding electrode to the tissue plane, e.g., the proximity to the closest tissue plane, alternatively defined as the shortest distance to the tissue plane. An electrical signal may be applied to the tissue (e.g., between the anchor 1220 and each of the electrodes 5140, 5142, 5414), and the data processing system may determine a differential orientation between the signals detected via each of the electrodes 5140, 5142, 5414. For example, the data processing system may determine the proximity of each electrode 5140, 5142, 5414 to the tissue plane and may determine the orientation in response to the difference between these proximity. A greater difference between the signals may indicate (e.g., may be determined to represent) a shallower orientation relative to the tissue plane, while little or no difference may indicate that the distal portion of the delivery tool 5250 is oriented transversely (e.g., directly ahead) relative to the tissue plane.

[0313] The signal may be (or may be detected as) a bioimpedance signal, for example, indicative of the bioimpedance of a tissue or tissues through which an electrical signal is conducted, which may be applied based on differences in bioimpedance between, for example, blood, valve annulus tissue, valve leaflet tissue, and / or myocardium.

[0314] Reference is again made to Figures 11 and 12. The scope of the present disclosure includes combinations of at least some of the features described with reference to Figure 11 and at least some of the features described with reference to Figure 12. For example, the delivery system may include multiple circumferential electrode rows (which provide the circumferential distribution in Figure 12) in an axially distributed manner along a distal portion of the delivery system (which provides the axial distribution in Figure 11). In some applications, the axial and circumferential distribution may be provided by multiple electrodes arranged in a helical distributed manner along and around the distal portion of the delivery system, or may be provided in another arrangement including multiple axial locations and multiple circumferential locations.

[0315] Referring again to FIGS. 1-12, as noted above, in applications where intracardiac navigation is facilitated by detection of intrinsic (e.g., ECG) signals, the dataset (e.g., the labeled dataset) may be used to, for example, construct a program to be executed by a data processing system, for example, to train an artificial intelligence and / or machine learning system, for example, prior to a procedure. Thus, intraoperative analysis of the detected intrinsic signals may be predicated on the entire dataset. Such techniques may be refined by using one or more initial (e.g., baseline) signals acquired at the start of a procedure, for example, with a distal portion of the delivery tool positioned away from the cardiac tissue. For example, such initial signal(s) may be acquired with the distal portion of the delivery tool positioned in the bloodstream but not in contact with solid tissue and / or at a relatively remote site, such as a large vein or aorta. Based on these initial signals, guidance may be facilitated (directly or indirectly) by using a narrower dataset (e.g., a subset of the dataset) that is more appropriate for the particular subject to be treated. For example, the data processing system may narrow the data set based on one or more parameters in the initial signal(s), such as, but not limited to, heart rate, arrhythmia, and / or ECG wave shape, e.g., ratios of various amplitudes and / or intervals, such as the ratio between P waves and QRS complexes. That is, the narrower data set may be from subjects (real-world and / or simulated subjects) that are generally more similar to and / or generally representative of the subject to be treated compared to the subjects in the entire data set with respect to one or more parameters.

[0316] In some applications, in response to the initial signal(s), the data processing system narrows (e.g., refines) the dataset being used (e.g., by classifying the subject and selecting an appropriate narrower dataset from a range of narrower datasets based on this classification). This may be performed as the delivery tool is driven forward into the heart prior to the actual intracardiac procedure. Thereafter, intraoperative analysis of intrinsic signals to facilitate intracardiac navigation is based on the narrower (e.g., selected) dataset, and thus, advantageously, position determination may be more accurate due to the narrower dataset being more representative of the subject being treated.

[0317] Referring again to Figures 1-12, although it was noted above that in some applications an exogenous electrical signal may be provided to facilitate sensing, the techniques described above are typically accomplished by detecting only physiological electrical signals (e.g., ECG signals), e.g., are performed without applying an exogenous electrical signal to the subject.

[0318] Referring again to Figures 1-12, one or more of the above-mentioned sensed signals (e.g., one or more of the above-mentioned extrinsic signals) may be (or may be sensed as) a bioimpedance signal, e.g., indicative of the bioimpedance of the tissue(s) through which the electrical signal is conducted. This may be applied, for example, based on differences in bioimpedance across blood, annulus tissue, leaflet tissue, and / or myocardium. Alternatively or additionally, such bioimpedance signals / measurements may be used to facilitate a determination of the degree of contact between a component (e.g., anchor) and a tissue, e.g., a contact surface area between the component and the tissue.

[0319] Referring again to Figures 1-12, in some applications, the data processing system (e.g., any of the data processing systems disclosed herein) may be a discrete (e.g., purpose-built) device or may be a component of such a device. In some applications, the data processing system (e.g., any of the data processing systems disclosed herein) may be a general-purpose data processing system (e.g., a processor of a general-purpose computer) that is programmed to execute a program.

[0320] In this disclosure, the term data processing system may refer to, be part of, or include application specific integrated circuits (ASICs), digital or analog or mixed analog / digital discrete circuits, digital or analog or mixed analog / digital integrated circuits, combinatorial logic circuits, field programmable gate arrays (FPGAs), processors (shared, dedicated, group) that execute code, memories (shared, dedicated, group) that store code executed by processors, other suitable hardware components such as optical or magnetic drives or solid state drives that provide the described functionality, or combinations of some or all of the above, such as systems on chips. As used above, the term code may include software, firmware, and / or microcode, and may refer to programs, routines, algorithms, functions, classes, and / or objects. The term shared processor encompasses a single processor that executes some or all of the code from multiple modules. The term group processor encompasses a processor that executes some or all of the code from one or more modules in combination with additional circuitry (e.g., processors). The term shared memory encompasses a single memory that stores some or all of the code from multiple modules. The term group memory encompasses memory that stores some or all of the code from one or more modules in combination with additional memory. The term memory may be a subset of the term computer-readable medium. The term computer-readable medium does not encompass transient electrical and electromagnetic signals propagating through the medium, and therefore may be considered tangible and non-transient. Non-limiting examples of non-transient tangible computer-readable media include non-volatile memory, volatile memory, magnetic storage, and optical storage.

[0321] It should be noted that although the devices and techniques described herein are shown in the figures on the left side of the heart (e.g., at the mitral valve), the devices and techniques described herein may be used, with modifications, on the right side of the heart (e.g., at the tricuspid valve) as well.

[0322] It should be noted that although the implants 222, 1210 are shown as annuloplasty implants, the techniques described herein may be used, with modifications, to facilitate implantation of other implants, such as other implants that are anchored to the annulus of an atrioventricular valve, such as certain leaflet restriction and / or leaflet manipulation implants. For example, the techniques described herein may be used to facilitate anchoring of one or more implants (e.g., implant 100 and variations thereof) described in International Patent Application No. PCT / US2021 / 039587 by Chau et al., published as International Publication No. WO2022 / 006087, which is incorporated herein by reference.

[0323] Any of the various systems, devices, apparatus, etc. of the present disclosure can be sterilized (e.g., by heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure safety for use on a patient, and methods herein can include sterilizing (e.g., by heat, radiation, ethylene oxide, hydrogen peroxide, etc.) the associated systems, devices, apparatus, etc. Additionally, the scope of the present disclosure includes sterilizing any of the various systems, devices, apparatus, etc. of the present disclosure in some applications.

[0324] Although the systems and techniques described herein are generally described for use with human subjects, any techniques, methods, operations, steps, etc. described or suggested herein may be performed in non-human animals or in non-biological simulations, such as cadavers, cadaver hearts, anthropomorphic ghosts, and / or simulator devices (which may include computerized and / or physical representations of body parts, tissues, etc.).

[0325] Although operations in some of the disclosed methods are described in a particular sequential order for convenience of presentation, it will be understood that this aspect of the description encompasses reordering, unless a particular order is required by specific language set forth below. For example, operations described sequentially can, in some cases, be reordered or performed simultaneously. Moreover, for the sake of simplicity, the accompanying drawings may not show various aspects in which the disclosed systems, apparatus, devices, methods, etc. can be used in combination with other systems, apparatus, devices, methods, etc. EXAMPLES

[0326] Application example (Some non-limiting examples of the concepts herein are listed below.)

[0327] Example 1. 1. A system for use with a subject's heart, comprising: Anchor and a delivery tool configured to deliver the anchor to the subject's heart and configured to drive the anchor into tissue of the heart; a data processing system, after the delivery tool delivers the anchor to the heart, configured to receive a first electrical signal via the delivery tool from an anchor located at the tissue and functioning as an electrode; configured to receive a second electrical signal via the delivery tool from a distal portion of the delivery tool located within the heart; configured to determine a position of the anchor within the heart in response to both the first electrical signal and the second electrical signal; and a data processing system configured to provide a position-indicated output.

[0328] Example 2. The system of Example 1, wherein the data processing system is configured to receive a first electrical signal before the delivery tool drives the anchor into the tissue, configured to receive a second electrical signal, configured to determine a position, and further configured to provide an output.

[0329] Example 3. The system of any one of Examples 1 to 2, wherein the anchor is a helical anchor.

[0330] Example 4. The data processing system, prior to receiving the first signal, configured to receive a first initial electrical signal via the delivery tool from an anchor located within the subject but spaced apart from the tissue and functioning as an electrode; configured to receive a second initial electrical signal via the delivery tool from a distal portion of the delivery tool located within the subject but spaced apart from the tissue; configured to assign the subject to a category in response to the first initial electrical signal and the second initial electrical signal; The system according to any one of the first to third embodiments, wherein the data processing signal is configured to determine a position in response to the first electrical signal, the second electrical signal, and the category.

[0331] Example 5. The system of example 4, wherein the data processing system is configured to receive the first initial electrical signal and the second initial electrical signal before the delivery tool delivers the anchor to the heart.

[0332] Example 6. The output is indicative of a position and orientation of the anchor within the heart; The data processing system is responsive to both the first signal and the second signal: and further configured to determine an orientation of the anchor within the heart. The system of any one of Examples 1 to 5, further configured to provide an output indicating a position and orientation of the anchor within the heart.

[0333] Example 7. The orientation is the orientation of the anchor relative to the atrioventricular axis of the heart; The output indicates a position and orientation relative to the atrioventricular axis; The data processing system is responsive to both the first signal and the second signal: configured to determine an orientation of the anchor relative to an atrioventricular axis; The system of Example 6, configured to provide an output indicating the position and orientation of the anchor relative to the atrioventricular axis.

[0334] Example 8. The orientation is the orientation of the anchor relative to the tissue plane of the heart; The output is an indication of position and orientation relative to a tissue plane; The data processing system is responsive to both the first signal and the second signal: configured to determine an orientation of the anchor relative to the tissue plane; The system of Example 6, configured to provide an output indicating the position and orientation of the anchor relative to the tissue plane.

[0335] Example 9. the heart having atria, ventricles, and valves located between the atria and the ventricles, the valves having annulus, the heart defining an atrioventricular axis extending from the atria to the ventricles; The position of the anchor is the position of the anchor along the atrioventricular axis; the data processing system is configured to determine a position of the anchor along the atrioventricular axis in response to both the first signal and the second signal after the delivery tool delivers the anchor to the heart; The output indicates a position of the anchor along the atrioventricular axis. The system of any one of Examples 1 to 8, wherein the data processing system is configured to provide an output indicating the position of the anchor along the atrioventricular axis.

[0336] Example 10. The data processing system is configured to: configured to simultaneously receive a first signal and a second signal; A system described in any one of Examples 1 to 9, configured to determine a position of an anchor within the heart in response to simultaneously received first and second signals.

[0337] Example 11. The system according to any one of the preceding claims, wherein the data processing system is configured to determine a difference between the first and second signals to determine a position of the anchor within the heart.

[0338] Example 12. The data processing system, after providing an output indicative of the position of the anchor within the heart and as the anchor is driven into the tissue, configured to determine a response of the tissue to the anchoring in response to at least one signal selected from the group consisting of the first signal and the second signal; The system of any one of Examples 1 to 11, configured to provide an output in response to the determined response indicating at least one of: (i) the depth of the anchor within the tissue; and (ii) the position of the anchor within the subject's heart.

[0339] Example 13. The anchor has a tissue engaging member and a head, and the data processing system provides an output indicative of a position of the anchor within the heart and as the anchor is driven into the tissue. configured to determine a response of the tissue to the anchoring in response to both the first signal and the second signal; configured to receive a head contact signal from the head of the anchor indicating contact of the head of the anchor with tissue; A system described in any one of Examples 1 to 12, configured to determine an attack angle of the anchor relative to the tissue in response to (i) the determined response and (ii) the head contact signal.

[0340] Example 14. the delivery tool includes a driver reversibly engageable with the anchor and configured to engage the anchor and drive the anchor into tissue; The system according to any one of the preceding embodiments, wherein the data processing system is configured to receive the first signal via a driver.

[0341] Example 15. The system of example 14, wherein the driver is disengageable from the anchor inside the heart.

[0342] Example 16. The driver is a tip reversibly engageable with the anchor; a shaft extending from a proximal end to a distal end of the driver, the shaft being configured to transmit torque from the proximal end to the distal end of the driver and the shaft being electrically conductive; The system of example 14, wherein the data processing system is configured to receive the first signal via the shaft.

[0343] Example 17. The driver is a tip reversibly engageable with the anchor; a shaft extending from a proximal end to a distal end of the driver, the shaft configured to transmit torque therefrom; a rod extending through the shaft to the tip, the rod being configured to control engagement of the tip with the anchor and the rod being electrically conductive; The system of example 14, wherein the data processing system is configured to receive the first signal via the rod.

[0344] Example 18. The system further includes an adjustment tool and an annuloplasty implant, the annuloplasty implant comprising: an anchor configured to anchor the implant to tissue; Tether, a contraction mechanism configured, when actuated, to contract the implant; the distal portion of the delivery tool includes a distal portion that is a distal portion of a guide member of the delivery tool and is mechanically connected to the retraction mechanism, the guide member extending proximally from the retraction mechanism and configured to translationally guide the adjustment tool relative to the retraction mechanism after anchoring the implant to the tissue, and the adjustment tool is configured to drive the retraction mechanism; A system described in any one of Examples 1 to 17, wherein the data processing system is configured to receive a second electrical signal from a distal portion of the guide member mechanically connected to the contraction mechanism after the delivery tool delivers the anchor to the heart.

[0345] Example 19. The system described in Example 18, wherein the distal portion of the guide member is mechanically and electrically connected to the retraction mechanism, and the data processing system is configured to receive a second electrical signal from the distal portion of the guide member that is mechanically and electrically connected to the retraction mechanism after the delivery tool delivers the anchor to the heart.

[0346] Example 20. The system described in Example 18, further comprising a sensing device including a data processing system and a connector, the connector being electrically and mechanically connectable to the proximal portion of the guide member in a manner such that the data processing system is configured to receive a second signal from the distal portion of the guide member via the connector.

[0347] Example 21. The system of Example 20, wherein the connector is an alligator clip that can be clipped onto the proximal portion of the guide member.

[0348] Example 22. The system of Example 20, wherein the distal portion of the guide member is mechanically and electrically connected to the retraction mechanism, and the connector is electrically and mechanically connectable to the proximal portion of the guide member in a manner configured such that the data processing system receives a second signal from the retraction mechanism via the guide member and the connector.

[0349] Example 23. The system described in Example 22, wherein after the adjustment tool drives the retraction mechanism, the guide member can be disconnected from the retraction mechanism within the body, thereby electrically isolating the retraction mechanism located inside the heart from the data processing system.

[0350] Example 24. A system described in any one of Examples 1 to 23, wherein the anchor defines a distal tip configured to penetrate cardiac tissue, and the data processing system is configured to receive a first signal when the distal tip of the anchor is positioned in abutment against the tissue.

[0351] Example 25. The system of Example 24, wherein the data processing system is configured to receive a first signal when the distal tip of the anchor is positioned against a cardiac tissue surface without penetrating the cardiac tissue.

[0352] Example 26. The system of Example 24, further comprising a sleeve configured to be anchored to tissue by the anchor, and the data processing system configured to receive a first signal when the sleeve is clamped between the distal tip and the tissue surface.

[0353] Example 27. The system of Example 24, wherein the data processing system is configured to receive a first signal when the distal tip of the anchor penetrates the cardiac tissue and is positioned within the cardiac tissue.

[0354] Example 28. The system described in any one of Examples 1 to 27, further comprising a sensing device including a data processing system and a first connector, the first connector being electrically and mechanically connectable to a proximal portion of the delivery tool, whereby the data processing system is configured to receive a first signal from the anchor via the first connector.

[0355] Example 29. The system of Example 28, wherein the first connector is an alligator clip that can be clipped onto the proximal portion of the delivery tool.

[0356] Example 30. The system described in Example 28, wherein the sensing device further includes a second connector, the second connector being electrically and mechanically connectable to the proximal portion of the delivery tool, such that the data processing system is configured to receive a second signal from the distal portion of the delivery tool via the second connector.

[0357] Example 31. The system of Example 30, wherein the second connector is an alligator clip that can be clipped onto the proximal portion of the delivery tool.

[0358] Example 32. The system of Example 30, wherein the second connector is an electronic snap.

[0359] Example 33. The heart has an atrium, a ventricle, and a valve located between the atrium and the ventricle, the valve having an annulus; the data processing system is configured to determine, after the delivery tool delivers the anchor to the heart, whether the position of the anchor is located at the valve annulus in response to both the first signal and the second signal; The output indicates whether the anchor is located at the annulus. The system of any one of Examples 1 to 32, wherein the data processing system is configured to provide an output indicating whether the anchor is located at the valve annulus.

[0360] Example 34. The data processing system is further configured to determine, after the delivery tool delivers the anchor to the heart, whether the location of the anchor is located at the atrium or at the ventricle in response to both the first signal and the second signal; The output indicates whether the anchor is located at the annulus, at the atrium, or at the ventricle; The system of Example 33, wherein the data processing system is configured to provide an output indicating whether the anchor is located at the valve annulus, at the atrium, or at the ventricle.

[0361] Example 35. the electrode is a first electrode, the anchor functions as the first electrode, A system described in any one of Examples 1 to 34, wherein the distal portion of the delivery tool includes a second electrode and the data processing system is configured to receive a second electrical signal from the second electrode.

[0362] Example 36. The system of Example 35, wherein the second electrode is disposed on a sidewall of the catheter of the delivery tool.

[0363] Example 37. the catheter includes a wire extending from the second electrode along the catheter to an external portion of the catheter; The system of Example 36, wherein the data processing system is configured to receive a second electrical signal from the second electrode via the wire.

[0364] Example 38. At the external portion of the catheter, the wires are terminated by a connector; The system of Example 37, wherein the data processing system is electrically and mechanically connectable to the second electrode via the connector.

[0365] Example 39. The system of Example 35, wherein the data processing system is configured to receive a second signal when the second electrode is suspended in the cardiac blood stream.

[0366] Example 40. The system of Example 35, wherein the data processing system is configured to receive the second signal when the second electrode is not in contact with cardiac tissue.

[0367] Example 41. The system of any one of Examples 1 to 40, further comprising a reference electrode configured to be placed outside the subject's heart, and the data processing system configured to determine a position in a manner facilitated by the reference electrode.

[0368] Example 42. The system of Example 41, wherein the reference electrode is a skin electrode configured to be placed on the skin of the subject.

[0369] Example 43. 1. A system for use with a subject's heart, comprising: Anchor and a delivery tool configured to deliver the anchor to the subject's heart and configured to drive the anchor into tissue of the heart; A data processing system, The delivery tool is configured to be electrically connected to the delivery tool, such that The data processing system is adapted to receive a first electrical signal from the anchor via the delivery tool; the data processing system adapted to receive a second electrical signal from a distal portion of the delivery tool, via the delivery tool; While the anchor is coupled to the delivery tool inside the heart, the data processing system configured to determine a position of the anchor within the heart in response to both the first signal and the second signal; The system is configured to provide a position indicated output.

[0370] Example 44. 1. A system for use with a subject's heart, comprising: It is an implant, Anchor and a tether coupleable to the anchor; a retraction mechanism for applying tension to the tether; and a driver configured to deliver the anchor to the subject's heart and configured to drive the anchor into tissue of the heart; a data processing system, after the driver delivers the anchor to the heart, configured to receive a first electrical signal from an anchor located at the tissue and functioning as a first electrode via a driver providing an electrical connection between the anchor and a data processing system; configured to receive a second electrical signal via a second electrical connection from a contractile mechanism located within the heart and functioning as a second electrode; configured to determine a position of the anchor within the heart in response to both the first signal and the second signal; and a data processing system configured to provide a position-indicated output.

[0371] Example 45. The system of Example 44, wherein the data processing system is configured to receive a first electrical signal before the delivery tool drives the anchor into the tissue, configured to receive a second electrical signal, configured to determine a position, and further configured to provide an output.

[0372] Example 46. The data processing system, after providing an output indicative of the position of the anchor within the heart and as the anchor is driven into the tissue, configured to determine a response of the tissue to the anchoring in response to at least one signal selected from the group consisting of the first signal and the second signal; The system of Example 44 or 45, configured to provide an output indicating at least one of (i) the depth of the anchor within the tissue and (ii) the position of the anchor within the subject's heart in response to the determined response.

[0373] Example 47. The anchor has a tissue engaging member and a head, and the data processing system provides an output indicative of a position of the anchor within the heart and as the tissue engaging member is driven into the tissue. configured to determine a response of the tissue to the anchoring in response to both the first signal and the second signal; configured to receive a head contact signal from the head of the anchor indicating contact of the head of the anchor with tissue; A system described in any one of Examples 44 to 46, configured to determine an attack angle of the anchor relative to tissue in response to (i) the determined response and (ii) the head contact signal.

[0374] Example 48. the heart having atria, ventricles, and valves located between the atria and the ventricles, the valves having annulus, the heart defining an atrioventricular axis extending from the atria to the ventricles; The position of the anchor is the position of the anchor along the atrioventricular axis; the data processing system is configured to determine a position of the anchor along the atrioventricular axis in response to both the first signal and the second signal after the driver delivers the anchor to the heart; The output indicates a position of the anchor along the atrioventricular axis. The system of any one of Examples 44 to 47, wherein the data processing system is configured to provide an output indicating the position of the anchor along the atrioventricular axis.

[0375] Example 49. A system described in any one of Examples 44 to 48, wherein the data processing system is configured to receive a second signal when the contractile mechanism is suspended in the blood flow of the heart.

[0376] Example 50. The system described in any one of Examples 44 to 49, wherein the data processing system is configured to receive a second signal when the contraction mechanism is not in contact with cardiac tissue.

[0377] Example 51. The data processing system is configured to: configured to simultaneously receive a first signal and a second signal; A system described in any one of Examples 44 to 50, configured to determine a position of an anchor within the heart in response to a first signal and a second signal received simultaneously.

[0378] Example 52. The system of any one of Examples 44 to 51, wherein the data processing system is configured to determine the position of the anchor inside the heart by determining the difference between the first signal and the second signal.

[0379] Example 53. A system described in any one of Examples 44 to 52, further comprising a sensing device including a data processing system and a first connector, the first connector being electrically and mechanically connectable to a proximal portion of the driver, whereby the data processing system is configured to receive a first signal from the anchor via the first connector.

[0380] Example 54. The system of Example 53, wherein the first connector is an alligator clip that can be clipped onto the proximal portion of the driver.

[0381] Example 55. The system of Example 53, wherein the first connector is an electronic snap.

[0382] Example 56. The system is Adjustment tools and a guide member mechanically connected to the retraction mechanism, the guide member extending proximally from the retraction mechanism and configured to translationally guide the adjustment tool relative to the retraction mechanism after anchoring the implant to the tissue, the adjustment tool configured to drive the retraction mechanism; The system described in any one of Examples 44 to 55, wherein the data processing system is configured to receive a second electrical signal from the retraction mechanism via the guide member.

[0383] Example 57. The system of Example 56, further comprising a sensing device including a data processing system and a connector, the connector being electrically and mechanically connectable to the proximal portion of the guide member in a manner configured such that the data processing system is configured to receive a second signal from the retraction mechanism via the guide member and the connector.

[0384] Example 58. The system of Example 57, wherein the connector is an alligator clip that can be clipped onto the proximal portion of the guide member.

[0385] Example 59. The system described in Example 56, wherein after the adjustment tool drives the retraction mechanism, the guide member can be disconnected from the retraction mechanism within the body, thereby electrically isolating the retraction mechanism located inside the heart from the data processing system.

[0386] Example 60. A system described in any one of Examples 44 to 59, wherein the driver is disengageable from the anchor inside the heart.

[0387] Example 61. The driver is a tip reversibly engageable with the anchor; a shaft extending from a proximal end to a distal end of the driver, the shaft being configured to transmit torque from the proximal end to the distal end of the driver and the shaft being electrically conductive; The system of Example 60, wherein the data processing system is configured to receive the first signal via the shaft.

[0388] Example 62. The driver is a tip reversibly engageable with the anchor; a shaft extending from a proximal end to a distal end of the driver, the shaft configured to transmit torque therefrom; a rod extending through the shaft to the tip, the rod being configured to control engagement of the tip with the anchor and the rod being electrically conductive; The system of Example 60, wherein the data processing system is configured to receive the first signal via the rod.

[0389] Example 63. A system described in any one of Examples 44 to 62, wherein the anchor defines a distal tip configured to penetrate cardiac tissue, and the data processing system is configured to receive a first signal when the distal tip of the anchor is positioned in abutment against the tissue.

[0390] Example 64. The system described in Example 63, wherein the data processing system is configured to receive a first signal when the distal tip of the anchor is positioned against a cardiac tissue surface without penetrating the cardiac tissue.

[0391] Example 65. The system of Example 63, wherein the implant further includes a sleeve configured to be anchored to the tissue by the anchor, and the data processing system is configured to receive a first signal when the sleeve is clamped between the distal tip and the tissue surface.

[0392] Example 66. The system described in Example 63, wherein the data processing system is configured to receive a first signal when the distal tip of the anchor penetrates the cardiac tissue and is positioned within the cardiac tissue.

[0393] Example 67. The heart has an atrium, a ventricle, and a valve located between the atrium and the ventricle, the valve having an annulus; the data processing system is configured to determine, after the driver delivers the anchor to the heart, whether the position of the anchor is at the valve annulus in response to both the first signal and the second signal; The output indicates whether the anchor is located at the annulus. The system of any one of Examples 44 to 66, wherein the data processing system is configured to provide an output indicating whether the anchor is located at the valve annulus.

[0394] Example 68. The data processing system is further configured to determine, after the driver delivers the anchor to the heart, whether the position of the anchor is located at the atrium or at the ventricle in response to both the first signal and the second signal; The output indicates whether the anchor is located at the annulus, at the atrium, or at the ventricle; The system of Example 67, wherein the data processing system is configured to provide an output indicating whether the anchor is located at the valve annulus, at the atrium, or at the ventricle.

[0395] Example 69. The system described in any one of Examples 44 to 68, further comprising a reference electrode configured to be placed outside the subject's heart, and the data processing system is configured to determine a position in a manner facilitated by the reference electrode.

[0396] Example 70. The system of Example 69, wherein the reference electrode is a skin electrode configured to be placed on the skin of the subject.

[0397] Example 71. 1. A system for use at the heart of a subject, comprising: Anchor, A tissue engaging member; and an anchor including an anchor head having a tissue-facing electrode; a driver configured to be engaged to the anchor head to drive the tissue engaging member into the tissue, thereby contacting the tissue facing electrode against the tissue surface of the heart; A data processing system, configured to receive, from the tissue-facing electrode, via the driver, an electrical signal indicative of contact between the tissue-facing electrode and tissue; a data processing system configured to provide an indication regarding contact of the anchor head with the tissue surface in response to the electrical signal.

[0398] Example 72. The system of Example 71, wherein the driver is configured to drive the tissue engaging member into the tissue such that the tissue opposing electrode is pressed against the tissue surface without penetrating the tissue.

[0399] Example 73. A system as described in Example 71 or 72, wherein the anchor can be electrically disconnected from the data processing system by disengaging the driver from the anchor head after the tissue engaging member has been driven into the tissue.

[0400] Example 74. The system of any one of Examples 71-73, wherein the anchor head defines a tissue-facing surface, the tissue-facing surface functioning as a tissue-facing electrode.

[0401] Example 75. The system of Example 74, wherein the driver is configured to drive the tissue engaging member into the tissue such that the tissue facing surface is pressed against the tissue surface without penetrating the tissue.

[0402] Example 76. The system of Example 74, wherein the anchor head is formed from a conductive material and the data processing system is configured to receive an electrical signal from the tissue facing surface via the anchor head.

[0403] Example 77. The system of any one of Examples 71 to 76, wherein the tissue engaging member is electrically insulated from the data processing system.

[0404] Example 78. The system of Example 77, wherein the tissue engaging member is electrically isolated from the data processing system by electrically insulating the tissue engaging member from the tissue opposing electrode.

[0405] Example 79. Anchorhead is an inner core, the tissue engaging member being coupled to the inner core; an outer layer engageable with a driver and functioning as a tissue facing electrode; and an insulating layer electrically insulating the inner core from the outer layer.

[0406] Example 80. The system described in any one of Examples 71 to 79, further comprising a sensing device including a data processing system and a connector, the connector being electrically and mechanically connectable to the proximal portion of the driver, whereby the data processing system is configured to receive an electrical signal from the tissue facing electrode via the connector.

[0407] Example 81. The system of Example 80, wherein the connector is an alligator clip that can be clipped onto the proximal portion of the driver.

[0408] Example 82. The system of Example 80, wherein the connector is an electronic snap.

[0409] Example 83. A system described in any one of Examples 71 to 82, wherein the driver is disengageable from the anchor head inside the heart.

[0410] Example 84. The driver is a tip reversibly engageable with the anchor head; a shaft extending from a proximal end to a distal end of the driver, the shaft being configured to transmit torque from the proximal end to the distal end of the driver and the shaft being electrically conductive; The system of Example 83, wherein the data processing system is configured to receive the electrical signal via the shaft.

[0411] Example 85. The driver is a tip reversibly engageable with the anchor head; a shaft extending from a proximal end to a distal end of the driver, the shaft configured to transmit torque therefrom; a rod extending through the shaft to the tip, the rod being configured to control engagement of the tip with the anchor and the rod being electrically conductive; The system of Example 83, wherein the data processing system is configured to receive the electrical signal via the rod.

[0412] Example 86. The system described in any one of Examples 71 to 85, further comprising a reference electrode configured to be placed outside the subject's heart, and the data processing system is configured to determine contact between the anchor head and the tissue surface in a manner facilitated by the reference electrode.

[0413] Example 87. The system of Example 86, wherein the reference electrode is a skin electrode configured to be placed on the skin of the subject.

[0414] Example 88. 1. A system for use at the heart of a subject, comprising: Anchor, A tissue engaging member; and an anchor including an anchor head; a driver configured to drive the tissue engaging member into the tissue of the heart while (i) electrically connecting to the electrode at the tissue-facing surface of the anchor head and (ii) electrically isolating from the tissue engaging member; a data processing system, wherein, when driving the tissue engaging member into the tissue, configured to receive an electrical signal from the electrode via a driver; a data processing system configured to provide an indication regarding contact of the anchor head with the tissue surface in response to the electrical signal.

[0415] Example 89. The system of Example 88, wherein the data processing system is configured to determine an attack angle of the anchor relative to the tissue in response to the electrical signal.

[0416] Example 90. 1. A device for use with (i) an anchor and (ii) a delivery tool including an anchor driver configured to translationally drive the anchor into cardiac tissue of a subject, the device comprising: a first wire electrically and mechanically connectable to a proximal portion of the anchor driver, the first wire electrically connecting the device to the anchor via the first wire and engaging a distal portion of the anchor driver to the anchor; a second wire electrically and mechanically connectable to a proximal portion of the delivery tool, the second wire electrically connecting the device to a distal portion of the delivery tool; a data processing system, (a) with a distal portion of the anchor driver engaged to the anchor, and (b) with the anchor and the distal portion of the delivery tool positioned within the heart; configured to determine a position of the anchor within the heart in response to electrical sensing via the first wire and the second wire; and a data processing system configured to provide a position-indicated output.

[0417] Example 91. and a third wire electrically and mechanically connected to a reference electrode configured to be placed external to the subject's heart, and the data processing system further comprises: configured to receive a first electrical signal between (i) a reference electrode and (ii) an anchor that functions as a first electrode within the heart; configured to receive a second electrical signal between (i) the reference electrode and (ii) the distal portion of the delivery tool; configured to determine a position of the anchor within the heart in response to the first signal and the second signal; 91. The device of example 90, configured to provide a position-indicated output.

[0418] Example 92. The data processing system configured to receive an electrical signal between (i) the anchor and (ii) a distal portion of the delivery tool via electrical sensing; configured to determine a position of the anchor within the heart in response to the electrical signal; 92. The device of example 90 or 91, configured to provide a position-indicated output.

[0419] Example 93. and a third wire electrically and mechanically connected to a reference electrode configured to be placed external to the subject's heart, and the data processing system further comprises: configured to receive a first electrical signal between (i) a reference electrode and (ii) an anchor that functions as a first electrode within the heart; configured to receive a second electrical signal between (i) the anchor and (ii) the distal portion of the delivery tool; configured to determine a position of the anchor within the heart in response to the first signal and the second signal; A device described in any one of Examples 90 to 92, configured to provide a position-indicating output.

[0420] Example 94. 1. A system for use at the heart of a subject, comprising: an implant configured to reduce regurgitation of a heart valve; an anchor for fixing the implant to cardiac tissue; A tissue engaging member; and an anchor including an anchor head; a driver configured to drive the tissue engaging member into the tissue to anchor the anchor to the tissue; a data processing system, wherein as the tissue engaging member is driven into the tissue, configured to receive, from the anchor via the driver, an electrical signal indicative of a response of the tissue to the anchoring; and a data processing system configured to provide an indication of a position of the anchor within the subject's heart in response to the electrical signal.

[0421] Example 95. The system of Example 94, wherein the anchor is a helical anchor.

[0422] Example 96. The electrical signal is a first electrical signal; The system is a delivery tool including a driver, the delivery tool configured to deliver the anchor to the heart of the subject; a second electrode disposed at a distal portion of the delivery tool; The data processing system detects when the tissue engaging member is being driven into the tissue. configured to receive a second electrical signal from the second electrode; The system of Example 94 or 95, configured to provide instructions regarding an anchor inside the subject's heart in response to the first signal and the second signal.

[0423] Example 97. the heart having atria, ventricles, and valves located between the atria and the ventricles, the valves having annulus, the heart defining an atrioventricular axis extending from the atria to the ventricles; The position of the anchor is the position of the anchor along the atrioventricular axis; The data processing system is configured to determine a position of the anchor along the atrioventricular axis in response to the electrical signals as the tissue engaging member is driven into the tissue; The output indicates a position of the anchor along the atrioventricular axis. The system of any one of Examples 94 to 96, wherein the data processing system is configured to provide an output indicating the position of the anchor along the atrioventricular axis.

[0424] Example 98. The system of any one of Examples 94 to 97, wherein the data processing system is further configured to determine an attack angle of the anchor relative to the tissue in response to the electrical signal.

[0425] Example 99. The system of any one of Examples 94 to 98, wherein the data processing system is further configured to determine a depth of the anchor within the tissue in response to the electrical signal.

[0426] Example 100. The system described in any one of Examples 94 to 99, further comprising a sensing device including a data processing system and a connector, the connector being electrically and mechanically connectable to the proximal portion of the driver, whereby the data processing system is configured to receive electrical signals from the anchor via the connector.

[0427] Example 101. The system of Example 100, wherein the connector is an alligator clip that can be clipped onto the proximal portion of the driver.

[0428] Example 102. The system of embodiment 100, wherein the first connector is an electronic snap.

[0429] Example 103. The electrical signal is a first electrical signal; The system is Adjustment tools and a delivery tool including a driver, the delivery tool configured to deliver the anchor to the heart of the subject; Implants are Tether, a contraction mechanism configured, when actuated, to contract the implant; a distal portion of the retraction mechanism is electrically and mechanically connected to a guide member extending proximally from the retraction mechanism, the guide member configured to translationally guide the adjustment tool relative to the retraction mechanism after anchoring the implant to the tissue, and the adjustment tool configured to drive the retraction mechanism; The data processing system detects when the tissue engaging member is being driven into the tissue. configured to receive a second electrical signal from the retraction mechanism via the guide member; A system described in any one of Examples 94 to 102, configured to provide an indication regarding the position of the anchor within the subject's heart in response to the first signal and the second signal.

[0430] Example 104. The system described in Example 103, further comprising a sensing device including a data processing system and a connector, the connector being electrically and mechanically connectable to the proximal portion of the guide member in a manner such that the data processing system is configured to receive a second signal from the distal portion of the guide member via the connector.

[0431] Example 105. The system described in Example 103, wherein after the adjustment tool drives the contraction mechanism, the guide member can be disconnected from the contraction mechanism within the body, thereby electrically isolating the contraction mechanism located inside the heart from the data processing system.

[0432] Example 106. The system of Example 103, wherein the data processing system is configured to receive a second signal when the contractile mechanism is not in contact with cardiac tissue.

[0433] Example 107. The data processing system detects when the tissue engaging member is being driven into the tissue. configured to simultaneously receive a first signal and a second signal; The system of Example 103, configured to determine a position of the anchor within the heart in response to the first and second signals received simultaneously.

[0434] Example 108. A system described in any one of Examples 94 to 107, wherein the driver is capable of being disengaged from the anchor inside the heart.

[0435] Example 109. The driver is a tip reversibly engageable with the anchor; a shaft extending from a proximal end to a distal end of the driver, the shaft being configured to transmit torque from the proximal end to the distal end of the driver and the shaft being electrically conductive; The system of Example 108, wherein the data processing system is configured to receive an electrical signal via the shaft.

[0436] Example 110. The driver is a tip reversibly engageable with the anchor; a shaft extending from a proximal end to a distal end of the driver, the shaft configured to transmit torque therefrom; a rod extending through the shaft to the tip, the rod being configured to control engagement of the tip with the anchor and the rod being electrically conductive; The system described in Example 108, wherein the data processing system is configured to receive the electrical signal via the rod.

[0437] Example 111. The heart has atria, ventricles, and valves located between the atria and the ventricles, the valves having annulus and cusps; The data processing system is configured to determine whether the location of the anchor is at the valve annulus in response to the electrical signal as the tissue engaging member is driven into the tissue; The output indicates whether the anchor is located at the annulus. The system of any one of Examples 94 to 110, wherein the data processing system is configured to provide an output indicating whether the anchor is located at the valve annulus.

[0438] Example 112. The data processing system is further configured to determine, in response to the electrical signal as the tissue engaging member is driven into the tissue, whether the location of the anchor is located at the atrium or at the ventricle; The output indicates whether the anchor is located at the annulus, at the atrium, or at the ventricle; The system of Example 111, wherein the data processing system is configured to provide an output indicating whether the anchor is located in the atrium, in the annulus, in the valve leaflet, or in the ventricle.

[0439] Example 113. The system described in any one of Examples 94 to 112, further comprising a reference electrode configured to be placed outside the subject's heart, and the data processing system is configured to determine a position in a manner facilitated by the reference electrode.

[0440] Example 114. The system of Example 113, wherein the reference electrode is a skin electrode configured to be placed on the skin of the subject.

[0441] Example 115. 1. A system for use at the heart of a subject, comprising: an implant configured to reduce regurgitation of a heart valve; an anchor for fixing the implant to cardiac tissue; A tissue engaging member; and an anchor including an anchor head; a driver configured to drive the tissue engaging member into the tissue to anchor the anchor to the tissue; a data processing system, wherein as the tissue engaging member is driven into the tissue, configured to receive, from the anchor via the driver, an electrical signal indicative of a response of the tissue to the anchoring; a data processing system configured to provide an indication of a depth of the tissue engaging member within the tissue in response to the electrical signal.

[0442] Example 116. The electrical signal is a first electrical signal; The data processing system a head contact signal is received from the anchor head via the driver, the head contact signal being an electrical signal indicating contact of the anchor head with the tissue surface; The system described in Example 115, configured to determine an attack angle of the anchor relative to tissue in response to (i) a first electrical signal and (ii) a head contact signal.

[0443] Example 117. The system of embodiment 116, wherein the data processing system is configured to provide an indication regarding the angle of attack in response to the angle of attack.

[0444] Example 118. The data processing system configured to determine whether the angle of attack is outside a predetermined range of angles of attack; In response to this, the system described in Example 116 is configured to provide an output indicating that the attack angle is outside of a predetermined attack angle range.

[0445] Example 119. 1. A system for use with an anchor and for use at the heart of a subject, comprising: A delivery tool, a proximal portion and a distal portion drivable in a translational manner forward into the heart; a catheter adapted to translate the anchor into the heart and adapted to drive the anchor into tissue of the heart; a delivery tool further comprising a first electrode and a second electrode at a distal portion; a data processing system electrically connectable to a proximal portion of the delivery tool; Receiving a first electrical signal from a first electrode; receiving a second electrical signal from a second electrode; determining an orientation of the distal portion within the heart in response to both the first signal and the second signal; and a data processing system including means for performing a method including:

[0446] Example 120. The system described in Example 119, wherein the first electrical signal is an intrinsic electrical signal, and the data processing system is configured to receive the intrinsic electrical signal from the first electrode.

[0447] Example 121. The system described in Example 119, wherein the first electrical signal is an exogenous electrical signal, the delivery tool is configured to apply the exogenous electrical signal, and the data processing system is configured to receive the exogenous electrical signal from the first electrode.

[0448] Example 122. A system described in any one of Examples 119 to 121, wherein the first electrode and the second electrode are axially distributed along the distal portion.

[0449] Example 123. A system described in any one of Examples 119 to 122, wherein the first electrode and the second electrode are circumferentially distributed around the distal portion.

[0450] Example 124. the delivery tool includes a third electrode at a distal portion; The method further includes receiving a third electrical signal from a third electrode; A system described in any one of Examples 119 to 123, wherein determining the orientation includes determining the orientation in response to a first signal, a second signal, and a third signal.

[0451] Example 125. The method is: determining a position of the first electrode within the heart in response to the first signal; determining a position of the second electrode within the heart in response to the second signal; A system described in any one of Examples 119 to 124, wherein determining the orientation includes determining the orientation in response to a position of the first electrode and a position of the second electrode.

[0452] Example 126. The system of Example 125, wherein determining the orientation includes determining the orientation (a) in response to a difference between a position of the first electrode inside the heart and a position of the second electrode inside the heart, and (b) in response to a distance between (i) a first electrode site where the first electrode is located on a distal portion and (ii) a second electrode site where the second electrode is located on a distal portion.

[0453] Example 127. The position of the first electrode is a position of the first electrode along an atrioventricular axis of the heart; The system of Example 125, wherein determining the orientation includes determining the orientation in response to a position of the first electrode along the atrioventricular chamber and in response to a position of the second electrode.

[0454] Example 128. The position of the second electrode is a position of the second electrode along an atrioventricular axis of the heart; The system of Example 127, wherein determining the orientation includes determining the orientation in response to a position of the first electrode along the atrioventricular axis and in response to a position of the second electrode along the atrioventricular axis.

[0455] Example 129. the location of the first electrode being a proximity of the first electrode to an endocardial tissue surface; The system of Example 125, wherein determining the orientation includes determining the orientation in response to a proximity of the first electrode to an intracardiac tissue surface and in response to a position of the second electrode.

[0456] Example 130. the location of the second electrode being a proximity of the second electrode to an endocardial tissue surface; The system of Example 129, wherein determining the orientation includes determining the orientation in response to a proximity of the first electrode to the intracardiac tissue surface and in response to a proximity of the second electrode to the intracardiac tissue surface.

[0457] Example 131. the orientation being of the distal portion relative to an atrioventricular axis of the heart; The output is indicative of a direction relative to the atrioventricular axis, Determining the orientation includes determining an orientation relative to an atrioventricular axis; A system described in any one of Examples 119 to 130, wherein providing an output includes providing an output indicating an orientation relative to the atrioventricular axis.

[0458] Example 132. the orientation being of the distal portion relative to a tissue plane of the heart; The output is an indication of the orientation relative to the tissue plane. The data processing system is responsive to both the first signal and the second signal: configured to determine an orientation relative to a tissue plane; The system of Example 119, configured to provide an output indicating an orientation relative to a tissue plane.

[0459] Example 133. the output being indicative of an orientation and position of the distal portion within the heart; The data processing system is responsive to both the first signal and the second signal: and further configured to determine a position of the distal portion within the heart. The system of Example 119, further configured to provide an output indicating the orientation and position of the distal portion within the heart.

[0460] Example 134. 1. A computer-implemented method comprising: receiving a first electrical signal from a first electrode disposed at a distal portion of a delivery tool positioned within the subject's heart; receiving a second electrical signal from a second electrode disposed at a distal portion of the delivery tool located within the heart; determining an orientation of the distal portion within the heart in response to both the first signal and the second signal; and providing an orientation indicated output.

[0461] Example 135. The method of example 134, wherein the first electrical signal is an intrinsic electrical signal, and receiving the first electrical signal comprises receiving an intrinsic electrical signal.

[0462] Example 136. The method of Example 134, wherein the first electrical signal is an exogenous electrical signal, the method further comprising applying the exogenous electrical signal, and receiving the first electrical signal comprises receiving the exogenous electrical signal.

[0463] Example 137. The method includes, prior to receiving the first signal, receiving a first initial electrical signal from a first electrode positioned within the subject but external to the heart; receiving a second initial electrical signal from the one disposed inside the subject and a second one disposed outside the heart; assigning the subject to a category in response to the first initial electrical signal and the second initial electrical signal; The method of any one of Examples 134 to 136, wherein determining the orientation includes determining the orientation in response to the first electrical signal, the second electrical signal, and the category.

[0464] Example 138. A data processing apparatus, comprising means for performing the steps of the method according to any one of Examples 134 to 137.

[0465] Example 139. A computer program comprising instructions which, when executed by a computer, cause the computer to carry out the method according to any one of Examples 134 to 137.

[0466] Example 140. A computer-readable medium having a computer program according to Example 139 stored thereon.

[0467] Example 141. 1. A computer-implemented method comprising: receiving a first electrical signal from an anchor in contact with tissue located within the subject's heart; receiving a second electrical signal from a second electrode suspended within the cardiac bloodstream; receiving a third electrical signal from a reference electrode positioned external to the subject's heart; calculating an improved signal in response to the first signal, the second signal, and the third signal, the improved signal representing a difference between the first signal and the second signal; and using the improved signal to provide an indication of a position of the anchor within the heart.

[0468] Example 142. The method includes, prior to receiving any of the first electrical signal, the second electrical signal, and the third electrical signal, receiving an initial signal from one or more of the anchor and the second electrode; and assigning the subject to a category in response to the initial signal; The method of example 141, wherein calculating the improved signal includes calculating the improved signal in response to the first signal, the second signal, the third signal, and the category.

[0469] Example 143. The method includes, prior to receiving any of the first electrical signal, the second electrical signal, and the third electrical signal, receiving an initial signal from one or more of the anchor and the second electrode; and assigning the subject to a category in response to the initial signal; The method of example 141, wherein providing the instruction by using the improved signal includes determining the instruction in response to the improved signal and the category.

[0470] Example 144. 1. A computer-implemented method for use with a subject's heart, comprising: receiving a first electrical signal from a tissue engaging member of the anchor in contact with tissue of the subject's heart; receiving a second electrical signal from the anchor head in contact with the cardiac tissue of the subject; providing an indication of a position of the anchor within the heart in response to the first signal; and in response to the second signal, providing an indication regarding contact of the anchor head with the tissue.

[0471] Example 145. 1. A computer-implemented method for use with a subject's heart, comprising: receiving an electrical signal from a tissue engaging member of the anchor in contact with the cardiac tissue; providing a first output indicative of a position of the anchor within the heart in response to the electrical signal before the tissue engaging member is driven into the tissue and while the tissue engaging member remains in contact with the tissue; continuing to receive an electrical signal as the tissue engaging member is driven into the tissue, the electrical signal indicating a response of the tissue to the anchoring; and providing a second output indicative of a position of the anchor within the heart in response to the electrical signal indicative of a response of the tissue.

[0472] Example 146. A data processing apparatus, comprising means for performing the steps of the method according to any one of Examples 141 to 145.

[0473] Example 147. A computer program comprising instructions which, when executed by a computer, cause the computer to carry out the method according to any one of Examples 141 to 145.

[0474] Example 148. A computer-readable medium having a computer program according to Example 147 stored thereon.

[0475] It will be readily apparent to those skilled in the art that the present invention is not limited to what has been particularly shown and described above, but rather, the scope of the present invention includes both combinations and subcombinations of the various features described above, as well as variations and modifications of those various combinations that do not exist in the prior art but which would occur to those skilled in the art upon reading the above description.

Claims

1. 1. A system for use with a subject's heart, comprising: Anchor and a delivery tool configured to deliver the anchor to the heart of the subject and to drive the anchor into tissue of the heart; a data processing system, wherein after the delivery tool delivers the anchor to the heart, configured to receive a first electrical signal via the delivery tool from the anchor located at the tissue and functioning as an electrode; configured to receive a second electrical signal through the delivery tool from a distal portion of the delivery tool located within the heart; configured to determine a position of the anchor within the heart in response to both the first electrical signal and the second electrical signal; a data processing system configured to provide an output indicative of said position.

2. 2. The system of claim 1, wherein the data processing system is configured to receive the first electrical signal, receive the second electrical signal, determine the position, and provide the output before the delivery tool drives the anchor into the tissue.

3. the output being indicative of the position and orientation of the anchor within the heart; The data processing system responds to both the first signal and the second signal by: further configured to determine the orientation of the anchor within the heart; The system of claim 1 , further configured to provide the output indicative of the position and the orientation of the anchor within the heart.

4. the orientation is an orientation of the anchor relative to a tissue surface of the heart; the output being indicative of the position and orientation relative to the tissue plane; The data processing system responds to both the first signal and the second signal by: configured to determine the orientation of the anchor relative to the tissue plane; The system of claim 3 , configured to provide the output indicating the position and the orientation of the anchor relative to the tissue plane.

5. The data processing system, after the delivery tool delivers the anchor to the heart, configured to simultaneously receive the first signal and the second signal; The system of claim 1 , configured to determine the position of the anchor within the heart in response to the first signal and the second signal received simultaneously.

6. the data processing system, after providing the output indicating the position of the anchor within the heart and as the anchor is driven into the tissue, configured to determine a response of the tissue to anchoring in response to at least one signal selected from the group consisting of the first signal and the second signal; 10. The system of claim 1, configured to provide an output in response to the determined response indicating at least one of: (i) a depth of the anchor within the tissue; and (ii) the location of the anchor within the heart of the subject.

7. the anchor having a tissue engaging member and a head, and the data processing system, after providing the output indicating the position of the anchor within the heart and as the anchor is driven into the tissue, configured to determine a response of the tissue to anchoring in response to both the first signal and the second signal; configured to receive a head contact signal from the head of the anchor indicating contact of the head of the anchor with the tissue; The system of claim 1 , configured to determine an angle of attack of the anchor relative to the tissue in response to (i) the determined response and (ii) the head contact signal.

8. the delivery tool includes a driver reversibly engageable with the anchor and configured to engage the anchor and drive the anchor into the tissue; 2. The system of claim 1, wherein the data processing system is configured to receive the first signal through the driver.

9. The driver a tip reversibly engageable with the anchor; a shaft extending from the proximal end of the driver to the distal end, the shaft configured to transmit torque from the proximal end of the driver to the distal end, the shaft being electrically conductive; The system of claim 8 , wherein the data processing system is configured to receive the first signal via the shaft.

10. The driver a tip reversibly engageable with the anchor; a shaft extending from a proximal end of the driver to the distal end, the shaft configured to transmit torque therefrom; a rod extending through the shaft to the tip, the rod configured to control engagement between the tip and the anchor, the rod being electrically conductive; The system of claim 8 , wherein the data processing system is configured to receive the first signal through the rod.

11. The system further includes an adjustment tool and an annuloplasty implant, the annuloplasty implant comprising: an anchor configured to anchor the implant to the tissue; Tether and a contraction mechanism configured, when actuated, to contract the implant; the distal portion of the delivery tool includes a distal portion of a guide member of the delivery tool that is mechanically connected to the retraction mechanism, the guide member extending proximally from the retraction mechanism and configured to guide the adjustment tool translationally relative to the retraction mechanism after anchoring the implant to the tissue, and the adjustment tool configured to drive the retraction mechanism; 2. The system of claim 1, wherein the data processing system is configured to receive the second electrical signal from the distal portion of the guide member mechanically connected to the retraction mechanism after the delivery tool delivers the anchor to the heart.

12. 12. The system of claim 11, wherein the distal portion of the guide member is mechanically and electrically connected to the retraction mechanism, and the data processing system is configured to receive the second electrical signal from the distal portion of the guide member that is mechanically and electrically connected to the retraction mechanism after the delivery tool delivers the anchor to the heart.

13. 2. The system of claim 1, wherein the anchor defines a distal tip configured to penetrate tissue of the heart, and the data processing system is configured to receive the first signal when the distal tip of the anchor is positioned against the tissue.

14. 14. The system of claim 13, wherein the data processing system is configured to receive the first signal when the distal tip of the anchor is positioned against a tissue surface of the heart without penetrating the tissue of the heart.

15. 14. The system of claim 13, wherein the data processing system is configured to receive the first signal when the distal tip of the anchor penetrates the tissue and is positioned within the tissue.

16. the heart has an atrium, a ventricle, and a valve located between the atrium and the ventricle, the valve having an annulus; the data processing system is configured to determine, after the delivery tool delivers the anchor to the heart, whether the position of the anchor is located in the valve annulus, the atrium, or the ventricle in response to both the first signal and the second signal; the output indicates whether the position of the anchor is located in the annulus, the atrium, or the ventricle; 2. The system of claim 1, wherein the data processing system is configured to provide the output indicating whether the position of the anchor is located in the valve annulus, the atrium, or the ventricle.

17. the electrode is a first electrode, and the anchor functions as the first electrode; The system of claim 1 , wherein the distal portion of the delivery tool includes a second electrode, and the data processing system is configured to receive the second electrical signal from the second electrode.

18. The system of claim 17 , wherein the second electrode is disposed on a sidewall of a catheter of the delivery tool.

19. 20. The system of claim 17, wherein the data processing system is configured to receive the second signal while the second electrode is suspended in the cardiac bloodstream.

20. The anchor has a tissue engaging member and a head, and wherein the data processing system, after providing the output indicating the position of the anchor within the heart and as the anchor is driven into the tissue, configured to receive a head contact signal from the head of the anchor indicating contact of the head of the anchor with the tissue; The system of claim 1 , configured to provide an indication of contact between the head and the tissue in response to the head contact signal.

21. A system for use with a subject's heart, comprising: Implants and Anchor and a delivery tool configured to deliver the anchor to the heart of the subject and to secure a tissue engaging element of the implant to tissue of the heart; a data processing system, after the delivery tool delivers the implant to the heart, receiving a first electrical signal via the delivery tool from the tissue engaging element positioned at the tissue, the tissue engaging element configured to function as an electrode; configured to receive a second electrical signal from another component of the implant via the delivery tool; configured to determine a position of the implant within the heart in response to both the first signal and the second signal; a data processing system configured to provide an output indicative of said location; A system that includes.

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