Patent Application
20240358514
Some applications of the present invention relate in general to systems and techniques for implanting an implant at or in a heart of a subject. More specifically, some applications of the present invention relate to systems and techniques for implanting an implant at or in a heart of a subject, guided by electrical signals.
Dilation of an annulus of a heart valve may occur due to various heart conditions, such as an enlarged heart chamber or a leaking heart valve. An annuloplasty procedure may be necessary to reshape, reinforce or tighten the annulus. Annuloplasty may be performed by implanting an annuloplasty implant to re-shape and/or re-size the annulus, for example, to reduce the size of the annulus.
Tissue anchors can be used to facilitate implantation of such annuloplasty implants, such as by coupling such implants to tissue of the heart. An anchor may be driven through the implant and into the tissue while the implant is held in place. Alternatively, the anchor may be implanted before introduction of the implant, and the implant subsequently coupled to the anchor.
Tissue anchors can also be used to facilitate implantation of other cardiac implants, such as other annulus-anchored implants.
The present disclosure relates, inter alia, to methods and systems of implanting an implant at a heart of a subject (e.g., a human subject), guided by electrophysiological signals produced by the heart—for example, using an anchor of the implant to serve as an electrode within the heart, in order to detect these electrophysiological signals.
Typically, before implanting of the implant in 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. Since the implant is typically attached to the heart via the anchor, it may be important for the anchor to be anchored precisely, according to the surgical plan, in order for the implant to serve the desired purpose. For example, for applications in which the implant is an annuloplasty implant, for implanting around an annulus of a valve of the heart, it is typically desirable to anchor anchors of the annuloplasty implant into the annulus—e.g., to drive the anchor through an atrial surface of the annulus. For some applications it is thus undesirable to anchor such anchors to other tissues, such as into the wall of the atrium upstream of the valve or the wall of the ventricle downstream of the valve.
In order to intraoperatively determine whether an anchor is optimally positioned for anchoring, prior to driving the anchor into the tissue, a distal tip of the anchor may be placed against the tissue. In this position, the anchor is used as an electrode via which a data-processing system, electrically connected to the anchor, can acquire electrical signals produced by the heart. Based on this information, the data-processing system provides an indication of the location of the anchor within the heart, which the operator (e.g., physician) can use to facilitate optimal anchoring of the anchor.
The data-processing system may be adapted to associate various electrical signals with corresponding locations of the electrode within the heart (e.g., different tissues of the heart, or different locations along an atrioventricular axis of the heart). For example, a signal acquired from an anchor placed against tissue of the annulus may be different from a signal acquired from the same anchor placed against tissue of the atrium, or placed against tissue of the ventricle. If the data-processing system determines that the anchor is located satisfactorily within the heart, the anchor can then be driven into the tissue.
For some applications, the data-processing system is electronically coupled to the anchor via an anchor driver, used to drive the anchor into the tissue. For example, a wire with a connector (e.g., a crocodile clip) at its end, may extend from the data-processing system, and may be mechanically and electrically connected to (e.g., clipped onto) a part of an electrically conductive shaft of the anchor driver that is disposed outside of the subject.
For 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 to be a second electrode, with the anchor being referred to as a first electrode. From the first and second signals, the data-processing system may derive a refined signal, which may be improved (e.g., to have a better signal-to-noise ratio) compared to the first signal alone.
For some such applications, the second electrode is not in contact with the tissue during the detection of the signals—e.g., it may be suspended in the bloodstream, within the heart. For example, the implantation system may be configured to facilitate such placement.
A reference electrode is typically placed on the subject at a distance to the heart, for example, on the skin of the subject, in order to acquire each of the first and second signals.
The above described application may be implemented during an annuloplasty procedure in which an annuloplasty implant is implanted around an annulus of a heart valve, in order to reduce valve regurgitation. The annuloplasty implant may comprise a contracting mechanism, such as a spool, in order to contract a tether of the implant once the implant has been implanted around the annulus, in order to reduce the circumference of the valve. For such an application, the contracting mechanism may serve as the second electrode. A guide member may extend, from the contracting mechanism, proximally out of the subject, e.g., in order to facilitate advancement of an adjustment tool therealong to actuate the contracting mechanism. The guide member may serve as a conductor from the contracting mechanism (serving as the second electrode). A second wire with a second connector at its end may extend from the data-processing system, and may be mechanically and electrically connected to (e.g., clipped onto) a part of the guide member that is disposed outside of the subject.
Additionally or alternatively, the above described application may be implemented by having the second electrode disposed on a distal end portion of a delivery catheter of the delivery tool, with a conductor extending proximally along the delivery catheter to an extracorporeal part of the delivery tool, where a wire may be mechanically and electrically connected to the conductor.
A technique for assessing whether an anchor has been fully driven into tissue of the heart is now described. For some applications, the anchor comprises a tissue-engaging element that is adapted to be driven into the tissue, and an anchor-head that has a tissue-facing surface that, once the tissue-engaging element has been fully driven into the tissue, contacts the tissue surface. The anchor is typically delivered to the heart and driven into the tissue using an anchor driver that is reversibly coupled to the anchor-head.
Receiving an indication that the anchor-head is in direct contact with the tissue surface may provide an indication that anchoring has been successful and/or is complete (e.g., that the anchor has been driven into the tissue to the required depth). In order to determine whether there is direct contact between the anchor-head and the tissue surface, a tissue-facing electrode disposed at the tissue-facing surface of the anchor-head serves as a detecting electrode, from which a data-processing system receives an electrical signal. Thus, once the tissue-facing surface of the anchor-head comes into direct contact with the tissue surface, the resulting electrical signal is received by the data-processing system, which responsively provides feedback that the anchor is properly implanted within the tissue. The data-processing system typically receives these electrical signals via the anchor driver.
A technique for assessing whether an anchor is being driven into tissue of the annulus is provided, in accordance with some applications. For some applications, subsequently to determining that an anchor is contacting tissue of the annulus, it is advantageous to continuously assess, during driving of the anchor into the tissue, whether the anchor is being anchored correctly (e.g., using methods similar to those described hereinabove). Different tissues of the heart may respond differently to the anchoring process, such that a data-processing system (e.g., a data-processing system as described hereinabove) may be able to provide an indication of the location and/or positioning of the anchor within the tissue, responsively to the anchoring. For example, the electrical signal detected by the anchor typically changes as the tissue-engaging element passes into solid tissue. The technique thus includes, by the anchor serving as an electrode within the heart, using the anchor to detect the electrophysiological signals produced by the heart, as the anchor is driven into the tissue, and responsively to the electrical signal, determining whether the anchor is being driven into the tissue as desired.
For some applications, one or more of the techniques described herein is augmented by electrical-sensing-based determination of an orientation of the distal part of the delivery system—e.g., via sensing of endogenous or exogenous electrical signals.
There is therefore provided, in accordance with some applications of the present invention, a system for use with a heart of a subject, the system including and anchor, a delivery tool, and a data-processing system. The delivery tool may be configured to deliver the anchor to the heart of the subject, and/or to drive the anchor into tissue of the heart. The data-processing system may be adapted to, subsequently to the delivery tool delivering the anchor to the heart, and prior to the delivery tool driving the anchor into the tissue:
For some applications, the data-processing system is adapted to receive the first electrical signal, receive the second electrical signal, determine the location, and/or provide the output, prior to the delivery tool driving the anchor into the tissue.
For some applications, the anchor is a helical anchor.
For some applications:
For some applications, the data-processing system is adapted to receive the first initial electrical signal and the second initial electrical signal prior to the delivery tool delivering the anchor to the heart.
For some applications,
For some applications:
For some applications:
For some applications:
For some applications, the data-processing system is adapted to, subsequently to the delivery tool delivering the anchor to the heart, and prior to the delivery tool driving the anchor into the tissue:
For some applications, the data-processing system is adapted to determine the location of the anchor within the heart by determining a difference between the first signal and the second signal.
For some applications, the data-processing system is adapted to, subsequently to providing the output indicative of the location of the anchor within the heart, and while the anchor is driven into the tissue:
For some applications, the anchor has a tissue-engaging element and a head, and
For some applications:
For some applications, the driver is disengageable from the anchor within the heart.
For some applications:
For some applications:
For some applications:
For some applications, the distal part of the guide member is mechanically and electrically connected to the contracting mechanism, and the data-processing system is adapted to, subsequently to the delivery tool delivering the anchor to the heart, and prior to the delivery tool driving the anchor into the tissue, receive the second electrical signal from the distal part of the guide member that is mechanically and electrically connected to the contracting mechanism.
For some applications, the system further includes a sensing device that includes the data-processing system and a connector, the connector being electrically and mechanically connectable to a proximal part of the guide member in a manner that configures the data-processing system to receive the second signal from the distal part of the guide member via the connector.
For some applications, the connector is a crocodile clip that is clippable onto the proximal part of the guide member.
For some applications, the distal part of the guide member is mechanically and electrically connected to the contracting mechanism, and the connector is electrically and mechanically connectable to the proximal part of the guide member in a manner that configures the data-processing system to receive the second signal from the contracting mechanism via the guide member and the connector.
For some applications, subsequently to actuation of the contracting mechanism by the adjustment tool, the guide member is intracorporeally disconnectable from the contracting mechanism such that the contracting mechanism, within the heart, becomes electrically isolated from the data-processing system.
For some applications, the anchor defines a distal tip, adapted to penetrate tissue of the heart, and the data-processing system is adapted to receive the first signal while the distal tip of the anchor is placed against the tissue.
For some applications, the data-processing system is adapted to receive the first signal while the distal tip of the anchor is placed against a surface of the tissue of the heart, not penetrating the tissue.
For some applications, the system further includes a sleeve adapted to be anchored to the tissue by the anchor, and the data-processing system is adapted to receive the first signal while the sleeve is sandwiched between the distal tip and a surface of the tissue.
For some applications, the data-processing system is adapted to receive the first signal while the distal tip of the anchor is disposed within the tissue, having penetrated the tissue.
For some applications, the system further includes a sensing device that includes the data-processing system and a first connector, the first connector being electrically and mechanically connectable to a proximal part of the delivery tool, thereby configuring the data-processing system to receive the first signal from the anchor via the first connector.
For some applications, the first connector is a crocodile clip that is clippable onto the proximal part of the delivery tool.
For some applications, the sensing device further includes a second connector, the second connector being electrically and mechanically connectable to a proximal portion of the delivery tool, thereby configuring the data-processing system to receive the second signal from the distal part of the delivery tool via the second connector.
For some applications, the second connector is a crocodile clip that is clippable onto the proximal part of the delivery tool.
For some applications, the second connector is an electronic snap.
For some applications:
For some applications:
For some applications:
For some applications, the second electrode is disposed on a lateral wall of a catheter of the delivery tool.
For some applications:
For some applications:
For some applications, the data-processing system is adapted to receive the second signal while the second electrode is suspended in a bloodstream of the heart.
For some applications, the data-processing system is adapted to receive the second signal while the second electrode does not contact the tissue of the heart.
For some applications, the system further includes a reference electrode, adapted to be placed outside of the heart of the subject, and the data-processing system is configured to determine the location, facilitated by the reference electrode.
For some applications, the reference electrode is a skin electrode, adapted to be placed on skin of the subject.
There is further provided, in accordance with some applications, a system for use with a heart of a subject, the system comprising an anchor, a delivery tool, and a data-processing system.
The delivery tool may be configured to deliver the anchor to the heart of the subject, and to drive the anchor into tissue of the heart.
The data-processing system may be adapted to be electrically connected to the delivery tool such that the data-processing system receives (i) via the delivery tool, a first electrical signal from the anchor, and/or (ii) via the delivery tool, a second electrical signal from a distal part of the delivery tool.
While the anchor is coupled to the delivery tool within the heart, the data-processing system may be configured to, responsively to both the first signal and the second signal, determine a location of the anchor within the heart, and provide an output indicative of the location.
There is further provided, in accordance with some applications of the present invention, a system for use with a heart of a subject, the system including an implant, a driver, and a data-processing system.
The implant may include an anchor, a tether, couplable to the anchor, and a contracting mechanism, for applying tension to the tether.
The driver may be configured to deliver the anchor to the heart of the subject, and to drive the anchor into tissue of the heart.
For some applications, the data-processing system is adapted to receive the first electrical signal, receive the second electrical signal, determine the location, and/or provide the output, prior to the delivery tool driving the anchor into the tissue.
The data-processing system may be adapted to, subsequently to the driver delivering the anchor to the heart, and prior to the driver driving the anchor into the tissue:
For some applications, the data-processing system is adapted to, subsequently to providing the output indicative of the location of the anchor within the heart, and while the anchor is driven into the tissue:
For some applications, the anchor has a tissue-engaging element and a head, and the data-processing system is adapted to, subsequently to providing the output indicative of the location of the anchor within the heart, and while the tissue-engaging element is driven into the tissue:
For some applications:
For some applications, the data-processing system is adapted to receive the second signal while the contracting mechanism is suspended in a bloodstream of the heart.
For some applications, the data-processing system is adapted to receive the second signal while the contracting mechanism does not contact the tissue of the heart.
For some applications, the data-processing system is adapted to, subsequently to the driver delivering the anchor to the heart, and prior to the driver driving the anchor into the tissue:
For some applications, the data-processing system is adapted to determine the location of the anchor within the heart by determining a difference between the first signal and the second signal.
For some applications, the system further includes a sensing device that includes the data-processing system and a first connector, the first connector being electrically and mechanically connectable to a proximal part of the driver, thereby configuring the data-processing system to receive the first signal from the anchor via the first connector.
For some applications, the first connector is a crocodile clip that is clippable onto the proximal part of the driver.
For some applications, the first connector is an electronic snap.
For some applications, the system further includes:
For some applications, the system further includes a sensing device that includes the data-processing system and a connector, the connector being electrically and mechanically connectable to a proximal part of the guide member in a manner that configures the data-processing system to receive the second signal from the contracting mechanism via the guide member and the connector.
For some applications, the connector is a crocodile clip that is clippable onto the proximal part of the guide member.
For some applications, subsequently to actuation of the contracting mechanism by the adjustment tool, the guide member is intracorporeally disconnectable from the contracting mechanism such that the contracting mechanism, within the heart, becomes electrically isolated from the data-processing system.
For some applications, the driver is disengageable from the anchor within the heart.
For some applications:
For some applications:
For some applications, the anchor defines a distal tip, adapted to penetrate tissue of the heart, and the data-processing system is adapted to receive the first signal while the distal tip of the anchor is placed against the tissue.
For some applications, the data-processing system is adapted to receive the first signal while the distal tip of the anchor is placed against a surface of the tissue of the heart, not penetrating the tissue.
For some applications, the implant further includes a sleeve adapted to be anchored to the tissue by the anchor, and the data-processing system is adapted to receive the first signal while the sleeve is sandwiched between the distal tip and a surface of the tissue.
For some applications, the data-processing system is adapted to receive the first signal while the distal tip of the anchor is disposed within the tissue, having penetrated the tissue.
For some applications:
For some applications:
For some applications, the system further includes a reference electrode, adapted to be placed outside of the heart of the subject, and the data-processing system is configured to determine the location, facilitated by the reference electrode.
For some applications, the reference electrode is a skin electrode, adapted to be placed on skin of the subject.
There is further provided, in accordance with some applications of the present invention, a system for use at a heart of a subject. The system may include an anchor which may include a tissue-engaging element and an anchor-head having a tissue-facing electrode.
A driver may be adapted to, via engagement with the anchor-head, place the tissue-facing electrode in contact with a surface of a tissue of the heart by driving the tissue-engaging element into the tissue.
A data-processing system may be adapted to receive, via the driver, an electrical signal from the tissue-facing electrode, the electrical signal being indicative of contact between the tissue-facing electrode and the tissue, and/or responsively to the electrical signal, providing an indication of contact between the anchor-head and the tissue surface.
For some applications, the driver is adapted to drive the tissue-engaging element into the tissue such that the tissue-facing electrode becomes pressed against the surface of the tissue without penetrating the tissue.
For some applications, the anchor is electrically disconnectable from the data-processing system subsequently to driving the tissue-engaging element into the tissue, by disengaging the driver from the anchor-head.
For some applications, the anchor-head defines a tissue-facing surface, and the tissue-facing surface serves as the tissue-facing electrode.
For some applications, the driver is adapted to drive the tissue-engaging element into the tissue such that the tissue-facing surface becomes pressed against the surface of the tissue without penetrating the tissue.
For some applications, the anchor-head is formed from an electrically conductive material, and the data-processing system is adapted to receive the electrical signal from the tissue-facing surface, via the anchor-head.
For some applications, the tissue-engaging element is electrically isolated from the data-processing system.
For some applications, the tissue-engaging element is electrically isolated from the data-processing system by the tissue-engaging element being electrically isolated from the tissue-facing electrode.
For some applications, the anchor-head includes:
For some applications, the system further includes a sensing device that includes the data-processing system and a connector, the connector being electrically and mechanically connectable to a proximal part of the driver, thereby configuring the data-processing system to receive the electrical signal from the tissue-facing electrode via the connector.
For some applications, the connector is a crocodile clip that is clippable onto the proximal part of the driver.
For some applications, the connector is an electronic snap.
For some applications, the driver is disengageable from the anchor-head within the heart.
For some applications:
For some applications:
For some applications, the system further includes a reference electrode, adapted to be placed outside of the heart of the subject, and the data-processing system is configured to determine contact between the anchor-head and the tissue surface, facilitated by the reference electrode.
For some applications, the reference electrode is a skin electrode, adapted to be placed on skin of the subject.
There is further provided, in accordance with some applications of the present invention, a system for use at a heart of a subject, the system including an anchor, a driver, and a data-processing system.
The anchor may include a tissue-engaging element, and an anchor-head.
The driver may be adapted to drive the tissue-engaging element into tissue of the heart, while (i) electrically connected with an electrode at a tissue-facing surface of the anchor-head, and (ii) electrically isolated from the tissue-engaging element.
The data-processing system may be adapted to, during driving of the tissue-engaging element into the tissue (i) receive, via the driver, an electrical signal from the electrode, and/or (ii) provide an indication of contact between the anchor-head and a surface of the tissue, responsively to the electrical signal.
For some applications, the data-processing system is adapted to, responsively to the electrical signal, determine an angle of attack of the anchor with respect to the tissue.
There is further provided, in accordance with some applications of the present invention, a device for use with (i) an anchor, and (ii) a delivery tool including an anchor driver adapted to transluminally drive the anchor into tissue of a heart of a subject.
The device may include a first wire, electrically and mechanically connectable to a proximal part of the anchor driver in a manner that electrically connects the device to the anchor via the first wire and engagement of a distal part of the anchor driver with the anchor, and a second wire electrically and mechanically connectable to a proximal part of the delivery tool in a manner that electrically connects the device to a distal part of the delivery tool.
A data-processing system may be adapted to, while (a) the distal part of the anchor driver is engaged with the anchor, and (b) the anchor and the distal part of the delivery tool are disposed within the heart (i) responsively to electrical sensing via the first wire and the second wire, determine a location of the anchor within the heart, and/or (ii) provide an output indicative of the location.
For some applications, the device further includes a third wire electrically and mechanically connected to a reference electrode adapted to be placed outside of the heart of the subject, and the data-processing system is adapted to:
For some applications, the data-processing system is adapted to:
For some applications, the device further includes a third wire electrically and mechanically connected to a reference electrode adapted to be placed outside of the heart of the subject, and the data-processing system is adapted to:
There is further provided, in accordance with some applications of the present invention, a system for use at a heart of a subject, the system including an implant, an anchor, a driver, and a data-processing system.
The implant may be adapted to reduce regurgitation of a valve of the heart.
The anchor may be for securing the implant to tissue of the heart. The anchor may include a tissue-engaging element, and an anchor-head.
The driver may be adapted to anchor the anchor to the tissue by driving the tissue-engaging element into the tissue.
The data-processing system may be adapted to, while the tissue-engaging element is being driven into the tissue:
For some applications, the anchor is a helical anchor.
For some applications:
For some applications:
For some applications, the data-processing system is further adapted to, responsively to the electrical signal, determine an angle of attack of the anchor with respect to the tissue.
For some applications, the data-processing system is further adapted to, responsively to the electrical signal, determine a depth of the anchor within the tissue.
For some applications, the system further includes a sensing device that includes the data-processing system and a connector, the connector being electrically and mechanically connectable to a proximal part of the driver, thereby configuring the data-processing system to receive the electrical signal from the anchor via the connector.
For some applications, the connector is a crocodile clip that is clippable onto the proximal part of the driver.
For some applications, the first connector is an electronic snap.
For some applications:
For some applications, the system further includes a sensing device that includes the data-processing system and a connector, the connector being electrically and mechanically connectable to a proximal part of the guide member in a manner that configures the data-processing system to receive the second signal from the distal part of the guide member via the connector.
For some applications, subsequently to actuation of the contracting mechanism by the adjustment tool, the guide member is intracorporeally disconnectable from the contracting mechanism such that the contracting mechanism, within the heart, becomes electrically isolated from the data-processing system.
For some applications, the data-processing system is adapted to receive the second signal while the contracting mechanism does not contact the tissue of the heart.
For some applications, the data-processing system is adapted to, during the tissue-engaging element being driven into the tissue:
For some applications, the driver is disengageable from the anchor within the heart.
For some applications:
For some applications:
For some applications:
For some applications:
For some applications, the system further includes a reference electrode, adapted to be placed outside of the heart of the subject, and the data-processing system is configured to determine the location, facilitated by the reference electrode.
For some applications, the reference electrode is a skin electrode, adapted to be placed on skin of the subject.
There is further provided, in accordance with some applications of the present invention, a system for use at a heart of a subject, the system including an implant, an anchor, a driver, and a data-processing system.
The implant may be adapted to reduce regurgitation of a valve of the heart.
The anchor may be for securing the implant to tissue of the heart. The anchor may include a tissue-engaging element, and an anchor-head.
The driver may be adapted to anchor the anchor to the tissue by driving the tissue-engaging element into the tissue.
The data-processing system may be adapted to, during the tissue-engaging element being driven into the tissue:
For some applications:
For some applications, the data-processing system is adapted to, responsively to the angle of attack, provide an indication of the angle of attack.
For some applications, the data-processing system is adapted to:
There is further provided, in accordance with some applications a system for use with an anchor and for use at a heart of a subject, the system including:
For some applications, the first electrical signal is an endogenous electrical signal, and the data-processing system is configured to receive the endogenous electrical signal from the first electrode.
For 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.
For some applications, the first electrode and the second electrode are distributed axially along the distal part.
For some applications, the first electrode and the second electrode are distributed circumferentially around the distal part.
For some applications:
For some applications:
For some applications, determining the orientation includes determining the orientation responsively to (a) a difference between the position of the first electrode within the heart and the position of the second electrode within the heart, and (b) a distance between (i) a first electrode-site at which the first electrode is disposed on the distal part, and (ii) a second electrode-site at which the second electrode is disposed on the distal part.
For some applications:
For some applications:
For some applications:
For some applications:
For some applications:
For some applications:
For some applications:
For some applications:
For some applications, the first electrical signal is an endogenous electrical signal, and receiving the first electrical signal includes receiving the endogenous electrical signal.
For some applications, the first electrical signal is an exogenous electrical signal, the method further includes applying the exogenous electrical signal, and receiving the first electrical signal includes receiving the exogenous electrical signal.
For some applications:
There is further provided, in accordance with some applications, a data-processing apparatus including means for carrying out the steps of the method.
There is further provided, in accordance with some applications, a computer program including instructions which, when the program is executed by a computer, cause the computer to carry out the method.
There is further provided, a computer-readable medium having stored thereon the computer program.
There is further provided, in accordance with some applications of the present invention, a computer-implemented method, including:
For some applications, the method further includes receiving a third electrical signal from a reference electrode outside of the heart of the subject.
For some applications, the method further includes calculating, responsively to the first signal and the second signal, a refined signal, the refined signal being representative of a difference between the first signal and the second signal.
For some applications, the refined signal is responsive to the first signal, the second signal, and the third signal.
The method may further include using the refined signal to provide an indication of a location of the anchor within the heart.
For some applications:
For some applications:
There is further provided, in accordance with some applications of the present invention, a computer-implemented method for use with a heart of a subject, the method including:
There is further provided, in accordance with some applications of the present invention, a computer-implemented method for use with a heart of a subject, the method including:
There is further provided, in accordance with some applications, a data-processing apparatus including means for carrying out the steps of the method.
There is further provided, in accordance with some applications, a computer program including instructions which, when the program is executed by a computer, cause the computer to carry out the method.
There is further provided, in accordance with some applications, a computer-readable medium having stored thereon the computer program.
This summary is meant to provide some examples and is not intended to be limiting of the scope of the invention in any way. For example, any feature included in an example of this summary is not required by the claims, unless the claims explicitly recite the features. Also, the features, components, steps, concepts, etc. described in examples in this summary and elsewhere in this disclosure can be combined in a variety of ways. Various features and steps as described elsewhere in this disclosure may be included in the examples summarized here.
Reference is now made to
In the example shown, implant 222 is an annuloplasty implant, such as an annuloplasty ring structure (e.g., comprising a flexible sleeve 26 and a contracting mechanism 40), but it is to be noted that the techniques disclosed herein may be used for other implants, mutatis mutandis. Sleeve 26 may comprise a braided fabric mesh, e.g., comprising polyethylene terephthalate (such as Dacron™). Implant 222 (e.g., sleeve 26 thereof) may be configured to be placed only partially around a cardiac valve annulus 10 (i.e., to assume a C-shape), or alternatively entirely around the valve annulus. Once anchored in place, implant 222 (e.g., sleeve 26 thereof) may be contracted so as to circumferentially tighten the valve annulus.
Sleeve 26 has (a) a tubular lateral wall 253 that (i) circumscribes a central longitudinal axis of the sleeve, and (ii) defines the lumen of the sleeve 26.
In order to tighten annulus 10, implant 222 comprises a flexible elongated contraction member 226 that extends along sleeve 26. Elongated contraction member 226 comprises a wire, a ribbon, a rope, or a band, which may comprise a flexible and/or superelastic material, e.g., nitinol, polyester, stainless steel, or cobalt chrome. For some applications, the wire comprises a radiopaque material. For some applications, contraction member 226 comprises a braided polyester suture (e.g., Ticron). For some applications, contraction member 226 is coated with polytetrafluoroethylene (PTFE). For some applications, contraction member 226 comprises a plurality of wires that are intertwined to form a rope structure.
Implant 222 may further comprise a contracting mechanism 40 (e.g., an adjustment mechanism), which facilitates contraction of the implant so as to facilitate adjusting of a perimeter of the annulus and leaflets of the cardiac valve. Contracting mechanism 40 comprises a rotatable structure (e.g., a spool, as described hereinbelow) that is disposed within a housing 44. For some applications of the present invention, contracting mechanism 40 comprises the housing 44. Contracting mechanism 40 may be surrounded by a braided mesh, coupled (e.g., by being sutured or otherwise coupled) to the braided mesh of sleeve 26. For some applications, and as shown, contracting mechanism 40 is coupled to an outer, lateral surface of sleeve 26.
For some applications, implant 222 (including contracting mechanism 40), and/or delivery tool 510 is as described in one or more of the following references, mutatis mutandis, each of which is incorporated by reference in its entirety:
Distal end portion 112 of outer catheter 12 is typically steerable. That is, distal end portion 112 is deflectable with respect to an immediately more proximal portion of catheter 12 (e.g., by using extracorporeal elements of tool 510). Distal end portion 112 may comprise a pull ring 511 that is coupled to two or more pull wires 29a and 29b, that are disposed within respective secondary lumens within a lateral wall of catheter 12 (as shown in section A-A of
Guide catheter 14 is steerable to a desired spatial orientation in order to facilitate advancing and implantation of an implant in a body cavity of the subject, typically an atrium upstream of an atrioventricular valve such as the mitral valve or the tricuspid valve.
For applications in which tool 510 is used to deliver an implant to the mitral valve of the subject, typically, outer catheter 12 is configured for initial advancement through vasculature of the subject until a distal end 102 of catheter 12 is positioned in the left atrium. The distal steerable end portion of catheter 12 is then steered such that distal end 102 of catheter 12 is positioned in a desired spatial orientation within the left atrium.
For applications in which tool 510 is used to deliver an implant to the tricuspid valve of the subject, outer catheter 12 is typically configured for initial advancement through vasculature of the subject until a distal end 102 of catheter 12 is positioned in the right atrium. The distal steerable end portion of catheter 12 is then steered such that distal end 102 of catheter 12 is positioned in a desired spatial orientation within the right atrium.
The steering procedure is typically performed with the aid of imaging, such as fluoroscopy, transesophageal echo, and/or echocardiography. Following the steering of the distal end portion of catheter 12, guide catheter 14 (which houses implant 222) is advanced through catheter 12 in order to facilitate delivery and implantation of implant 222 along the annulus of the mitral valve. During the delivery, at least a portion of steerable distal end portion 114 is exposed from distal end 102 of catheter 12 and is thus free for steering toward the annulus of the mitral valve, as is described hereinbelow.
During delivery of sleeve 26 to the annulus of the cardiac valve, sleeve 26 and contracting mechanism 40 are disposed within a lumen of catheter 14 and are typically aligned longitudinally with a longitudinal axis of catheter 14. Mechanism 40 can be coupled to sleeve 26 in a manner that allows mechanism 40 to move (e.g., to translate) from a state in which it is in line with the longitudinal axis of catheter 14 (
A flexible, longitudinal guide member 86 (e.g., a wire) is coupled to a portion of contracting mechanism 40 (e.g., a portion of the rotatable structure, as described hereinbelow). Guide member 86 has a thickness of 0.35-0.45 mm, e.g., 0.4 mm. Guide member 86 is configured to facilitate guiding of adjustment tool 87 via guide member 86 and toward the rotatable structure of contracting mechanism 40. Typically, adjustment tool 87 is configured to engage the rotatable structure of contracting mechanism 40 following implantation of sleeve 26 along the annulus of the cardiac valve (e.g., as described, mutatis mutandis, in US 2014/0309661 to Sheps et al. and/or US 2015/0272734 to Sheps et al, each of which is incorporated herein by reference). Guide member 86 extends from contracting mechanism 40, alongside a portion of distal end portion 114 of guide catheter 14, and into a secondary lumen in the wall of guide catheter 14 via an opening 15 in guide catheter 14. Guide member 86 extends through the secondary lumen of guide catheter 14 (as shown in section A-A in
In addition, system 500 comprises a plurality of anchors 32, typically between about 5 and about 20 anchors, such as about 10 or about 16 anchors. Each anchor 32 may comprise a tissue-coupling element 60 (e.g., a helical tissue-coupling element), and a tool-engaging head 62 (e.g., a non-helically-shaped portion), fixed to one end of the tissue-coupling element. Only one anchor 32 is shown in
Typically, but not necessarily, anchors 32 comprise a biocompatible material such as stainless steel 316 LVM. For some applications, anchors 32 comprise nitinol. For some applications, at least one part of each anchor 32 is coated with a non-conductive material.
Deployment manipulator 61 comprises anchor driver 36 and deployment element 38. For some applications, deployment manipulator 61 comprises channel 18.
Sleeve 26 is typically disposed within a lumen of guide catheter 14. Forces are applicable to a proximal end of sleeve 26 via a reference-force tube 19, a distal end of which is coupled to the proximal end of the sleeve. As shown, an implant-decoupling channel 18 is advanceable within a lumen of reference-force tube 19 and within a lumen of sleeve 26. As shown in the enlarged image of
For some applications, channel 18 is steerable.
Typically, manipulator 61 advances within channel 18. For some applications, tool 510 comprises a plurality of anchor drivers 36 of manipulator 61, each driver 36 being coupled to a respective anchor 32. Each driver 36 is advanced within channel 18 in order to advance and implant anchor 32 in tissue. Following implantation of anchor 32, anchor 32 is decoupled from driver 36, as described herein, and driver 36 is removed from within channel 18. A subsequent anchor 32 is then advanced within channel 18 while coupled to a driver 36 (e.g., a new driver).
As will be described hereinbelow, and as shown in
For some applications, sleeve 26 comprises a plurality of radiopaque markers 25, which are positioned along the sleeve at respective longitudinal sites. The markers 25 may provide an indication in a radiographic image (such as a fluoroscopy image) of how much of the sleeve 26 has been deployed at any given point during an implantation procedure, in order to enable setting a desired distance between anchors 32 along the sleeve 26. For some applications, the markers comprise a radiopaque ink.
Typically, at least some (e.g., at least three, such as all) of the longitudinal sites are longitudinally spaced at a constant interval. 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 equal to the desired distance between adjacent anchors. For example, the markers 25 may comprise first, second, and third markers, which first and second markers are adjacent, and which second and third markers are adjacent, and the distance between the proximal and/or distal edges of the first and second markers equal the corresponding distance between the proximal and/or distal edges of the second and third markers. For example, the distance may be between 3 and 15 mm, such as 6 mm, and the longitudinal length of each marker may be between 0.1 and 14 mm, such as 2 mm. (If, for example, the distance was 6 mm and the lengths were 2 mm, the longitudinal gaps between adjacent markers would have lengths of 4 mm.)
Each anchor 32 is coupled to deployment element 38 of an anchor driver 36. Anchor driver 36 typically comprises an elongate and flexible shaft (which is typically tubular) having at least a flexible distal end portion. The elongate shaft of driver 36 extends within a lumen of channel 18, through tool 510 toward a proximal end of a proximal handle portion 101 of tool 510. The tube of anchor driver 36 provides a lumen for slidable advancement therethrough of an elongate rod 130. Rod 130 facilitates the locking and unlocking of anchor 32 to deployment element 38. As shown in Section E-E of
Proximal handle portion 101 is supported by a stand having support legs 91 and a handle-sliding track 90. Handle portion 101 comprises an outer-catheter handle 22, a guide-catheter handle 24, an implant-manipulating handle 126, and anchor-release mechanism 28. Handle 22 is coupled to a proximal end of outer catheter 12. Handle 24 is coupled to a proximal portion of guide catheter 14. Handle 126 is coupled to a proximal portion of reference-force tube 19, and linear movement of handle 126 with respect to handle 24 moves reference-force tube 19 (and thereby typically implant 222) through catheter 14. As described hereinabove, housing 135 of anchor-release mechanism 28 is coupled to a proximal portion of the tube of anchor driver 36. The relative positioning of each of the concentrically-disposed components of tool 510 is shown in the exploded view and sections A-A, C-C, and D-D of
The stand supporting proximal handle portion 101 may be moved distally and proximally to control a position of the entire delivery tool 510, particularly so as to adjust a distance of distal end 102 of catheter 12 from the interatrial septum. Handle 22 comprises a steering knob 210 that is coupled to steering wires 29a and 29b disposed within respective secondary lumens in the wall of outer catheter 12. Rotation of knob 210 adjusts a degree of tension of wires 29a and 29b which, in turn, apply a force to pull ring 511 at the distal end portion of outer catheter 12. Such force steers the distal end portion of catheter 12 within the atrium of the heart of the subject in a manner in which the distal end portion of catheter 12 is steered in a first steering plane that is typically parallel with the plane of the annulus of the valve (e.g., in a direction from the interatrial septum toward surrounding walls of the atrium). For some applications of the present invention, the distal end portion of catheter 12 may be pre-shaped so as to point downward toward the valve. For some applications, the distal end portion of catheter 12 may be pulled to assume an orientation in which the distal end portion points downward toward the valve. For some applications of the present invention, the distal end portion of catheter 12 is not made to point downward toward the valve.
Handle 24 is coupled to track 90 via a first mount 92. Mount 92 is slidable proximally and distally along track 90 in order to control an axial position of guide catheter 14 with respect to outer catheter 12. Mount 92 is slidable via a control knob 216. For example, control knob 216 of mount 92 controls the proximal and distal axial movement of the distal steerable portion of guide catheter 14 with respect to distal end 102 of outer catheter 12. Handle 24 comprises a steering knob 214 that is coupled to steering wires 31a and 31b disposed within respective secondary lumens in the wall of guide catheter 14. Rotation of knob 214 adjusts a degree of tension of wires 31a and 31b which, in turn, apply a force to pull ring 13 at the distal end portion of guide catheter 14. Such force steers the distal end portion of catheter 14 in a second steering plane within the atrium of the heart of the subject, typically downward and toward the annulus of the cardiac valve. Typically, as described hereinbelow, the distal end portion of guide catheter 14 is steered in the second plane that is substantially perpendicular with respect to the first plane in which the distal end portion of outer catheter 12 is steered.
The combined steering of the respective distal end portions of catheters 12 and 14 directs sleeve 26 down toward the annulus (e.g., via the steering of the distal end portion of catheter 14) and along the perimeter of annulus (e.g., from the posterior section of the valve to the anterior section of the valve, and vice versa), via the steering of the distal end portion of catheter 12.
For some applications, handle 22 may be tilted by the operating physician, in order to further adjust a position of the distal end of catheter 12.
Handle 126 is slidably coupled to track 90 via a second mount 93. Mount 93 is slidable proximally and distally along track 90, in order to control an axial position of reference-force tube 19 and at least a proximal portion of sleeve 26 with respect to guide catheter 14. For some applications, mount 93 comprises a control knob 95. For some such applications, control knob reversibly locks mount 93 to track 90, thereby reversibly inhibiting sliding of the mount along the track. Alternatively or additionally, turning of control knob 95 may cause sliding of mount 93 along track 90 (e.g., acting like a rack and pinion). For some applications, friction between (i) reference-force tube 19 and (ii) catheter 14 and/or handle 24 reduces a likelihood of inadvertent sliding of tube 19 through catheter 14, and thereby obviates the need for locking of mount 93 to track 90. Taken together with the steering of the distal end portion of guide catheter 14, such movement of tube 19 and at least the proximal portion sleeve 26 moves the proximal portion of sleeve 26 toward a desired portion of tissue of the annulus of the valve during deployment of anchors 32 from within the lumen of sleeve 26, as is described hereinbelow.
As is described hereinabove, in order to decouple sleeve 26 from a portion of an outer surface of channel 18, (1) channel 18 is pulled proximally, while (2) reference-force tube 19 is maintained in place. A proximal end of channel 18 is coupled to a knob 94 which adjusts an axial position of channel 18 proximally and distally with respect to reference-force tube 19 and sleeve 26.
Typically, handle portion 101 comprises a release-decision-facilitation member, such as a latch or button, that automatically engages when a given length of sleeve 26 has advanced off channel 18 (e.g., when channel 18 is at a given position with respect to tube 19); typically, just before sleeve 26 becomes completely decoupled from channel 18.
Handle portion 101 (comprising handles 22, 24, and 126 and anchor-release mechanism 28) has a length Li of between 65 and 85 cm, e.g., 76 cm. Typically, as shown, a majority of the body portion of outer-catheter handle 22 is disposed at a non-zero angle with respect to a longitudinal axis ax1 of the multiple components of tool 510. The steering mechanism provided by handle 22 in order to steer the distal end portion of catheter 12 is disposed within the portion of handle 22 that is disposed at the non-zero angle with respect to axis ax1. Handle 22 comprises an in-line tubular portion which is longitudinally disposed in-line along axis ax1 and coaxially with respect to handles 24 and 126 and release mechanism 28. The in-line tubular portion is shaped so as to define a lumen for inserting guide catheter 14 therethrough and subsequently into the lumen of outer catheter 12. The in-line tubular portion has a length L24 of between 7 and 11 cm, e.g., 7 cm. Such spatial orientation of the majority of handle 22 at an angle with respect to axis ax1 reduces an overall functional length of handle portion 101.
In order to intraoperatively determine whether an anchor 32 is optimally positioned for anchoring, prior to driving the anchor into the tissue, the anchor 32 is typically placed against the tissue at a potential anchoring site, and the anchor 32 serves as a sensing electrode, via which data-processing system 521, electrically connected to the anchor, can acquire an electrical signal produced by the heart. Based on the detected signal (hereinbelow referred to as “the first signal”), data-processing system 521 provides an indication of the location of the anchor 32 within the heart, which the operator (e.g., physician) can use to facilitate optimal anchoring of the anchor.
As shown in
In applications in which rod 130 is used in order to facilitate the locking and unlocking of anchors 32 to deployment element 38, the rod may itself serve as the electrical connection between anchor 32 and connector 534 e.g., by the rod itself being electrically conductive and/or having an electrically conductive element extending therethrough or therealong. For such applications, electrical connection between rod 130 and connector 534 may be achieved via part of the rod being exposed at a proximal end of anchor driver 36 (e.g., through a window defined in the shaft of the anchor driver or in housing 135, or protruding proximally from the housing), or via part of the shaft or part of the housing of the anchor driver being conductive, and providing an electrical connection between the connector and the rod.
In this state, anchor 32 is thus usable as an electrode to detect electrophysiological signals produced by the heart, during implantation (e.g., of implant 222) within the heart.
As described hereinabove, anchor 32 is typically placed against the tissue at a potential anchoring site in order for data-processing system 521 to assess the suitability of the potential anchoring site within the heart for anchoring of the anchor. It is to be noted that, in this context, the term “placed against” may include (i) placing the anchor in direct contact with the surface of the tissue at the potential anchoring site, (ii) driving the anchor at least partway into the tissue, or (iii) sandwiching sleeve 26 between the anchor and the tissue (e.g., without direct contact between the anchor and the tissue).
For some applications, data-processing system 521 also receives an electrical signal (i.e., a second electrical signal) from an additional component of the implantation system within the heart (e.g., from delivery tool 510 and/or an additional component of 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., for sensing the electrophysiological signals produced by the heart), with the anchor being referred to as a first electrode. From the first and second signals, data-processing system 521 may derive a refined signal, which may be improved (e.g., to have a better signal-to-noise ratio) compared to the first signal alone. The refined signal may be used to provide an indication to the operator of the location of anchor 32 within the heart. Various applications are described hereinbelow for the second electrode, e.g., for some applications, an electrode 140 disposed at a distal part of catheter 14 serves as the second electrode (
One or more reference electrodes 536, placed outside of the heart (e.g., on the skin of the subject, such as on a leg of the subject, as shown in
For some applications, rather than data-processing system 521 receiving discrete first and second signals and deriving a refined signal therefrom, the data-processing system 521 may more directly receive the refined signal as a trace between the first electrode and the second electrode (e.g., a “bipolar signal”). For such applications, even though the refined signal is typically a product of the measured difference in electrical potential between these two electrodes, the electrical connection between data-processing system 521 and the first electrode may be considered to provide a “first signal” and the electrical connection between the data-processing system and the second electrode may be considered to provide a “second signal.”
Data-processing system 521 may be adapted to, responsively to the first signal, the second signal, and/or a refined signal, determine the location of the anchor within the heart. That is, data-processing system 521 may be adapted to associate various signals with corresponding locations of anchor 32 within the heart (e.g., different tissues of the heart, or different locations along an atrioventricular axis of the heart). For example, a refined signal indicative of the anchor being placed against tissue of the annulus may be different than a refined signal indicative of the same anchor placed against tissue of atrium 6 or placed against tissue of the ventricle 8. If the data-processing system determines that the anchor is located satisfactorily within the heart, the anchor can then be driven into the tissue.
The refined signal which results from placing more than one electrode within the heart may advantageously improve the ability of data-processing system 521 to identify the location of anchor 32 within the heart, as compared with a signal that might be obtained by placing only a single electrode in the heart. For example, the refined signal may have an improved signal-to-noise ratio than an application in which only a single electrode is placed within the heart.
Prior to anchor 32 contacting the tissue, the baseline of the refined signal may be approximately zero (
Typically, device 520 (e.g., data-processing system 521 thereof) runs a program in which at least one of the first, second, and refined signals serves as an input, and which responsively determines the location of anchor 32 within the heart. As described hereinabove, the program may receive the refined signal directly, or may derive the refined signal from the first and second signals (e.g., by subtraction). For some applications, the program determines the location of anchor 32 responsively to the refined signal alone. For some applications, the program determines the location of anchor 32 responsively to both the refined signal and the first signal. For some applications, the program determines the location of anchor 32 responsively to both the refined signal and the second signal.
For some applications, by running the program, data-processing system 521 determines a location of anchor 32 along the atrioventricular axis of the heart. For some such applications, data-processing system 521 determines whether anchor 32 is disposed in a predefined discrete position (which may be one of multiple predefined discrete positions), such as within the atrium, at the annulus, or within the ventricle. Additionally or alternatively, the data-processing system may determine whether the anchor is in contact with a discrete type of tissue, such as atrial wall tissue, annulus tissue, leaflet tissue, or ventricular wall tissue.
For some applications, artificial intelligence and/or machine learning is employed in the building of the program. For example, building of the program may be facilitated by the artificial intelligence analyzing data (e.g., a labeled data set) that may include (e.g., refined signals, first signals, second signal, and/or other ECG data obtained from previously performed procedures). For some applications, in order to train (e.g., further train) the program, the location outputted intra-procedurally by the program is compared to the actual location of the anchor (e.g., determined by other means).
Experiments have indicated that, for at least some applications in which the program is built and/or trained using artificial intelligence and/or machine learning, determining the location responsively to both the refined signal and the first signal (e.g., using both signals as inputs) can provide a more accurate determination of the location of anchor 32, compared to using either the first signal or the refined signal as an input without the other.
Device 520 typically comprises a display 528, for providing the operator with an output indicative of the location of anchor 32 that has been determined by the program run by data-processing system 521. For example, the output may be indicative of a location along the atrioventricular axis of the heart.
For some applications, and as illustrated in
For some applications, device 520 is configured to provide the output (e.g., on display 528) as a binary output (e.g., a yes/no or go/no-go output), responsively to data-processing system 521 determining that anchor 32 can be driven into the tissue at a potential anchoring site (e.g., by determining that the anchor is contacting tissue of the annulus).
For some applications, device 520 is not used as a primary navigation device, but instead is used to augment navigation/guidance provided by other means, such as imaging (e.g., fluoroscopy and/or ultrasound). For example, device 520 may be used to provide verification of the location of an anchor that has been determined via imaging. For example, the operator may perform an implantation procedure guided primarily by imaging but may drive the anchor into tissue only upon observing an output indicative of the anchor being in contact with tissue of the annulus, or only upon an absence of a warning that the anchor is in contact with tissue that is not of the annulus.
For some applications, the operator may reposition anchor 32 within the heart responsively to the output presented by display 528. For example,
For some applications, data-processing system 521 is supplied with a surgical plan, and is used to provide the operator with an indication of whether the anchor is positioned within the heart according to the surgical plan, responsively to the refined signal.
For some applications, display 528 alternatively or additionally presents a graphical representation of at least one of the first signal, the second signal, and the refined signal (e.g., as illustrated in
Alternatively or additionally to using display 528 to provide a visual output, device 520 may provide its output via a different medium, such as an audio or tactile/haptic output.
Implant 1210 is typically an annuloplasty implant, and comprises a plurality of anchors 1220, and a contraction member 1212 (e.g., a tether). Each anchor 1220 typically comprises an anchor head 1280 having an eyelet 1240 through which contraction member 1212 is threaded, and a tissue-engaging element 1230 configured to be driven into tissue of annulus 10.
In contrast to implant 222 of system 500, implant 1210 does not comprise a sleeve (e.g., sleeve 26). Rather, in order to contract the annulus and reduce valve regurgitation, the anchors are typically driven into tissue of the annulus while threaded onto contraction member 1212, and the contracting member is subsequently tensioned in order to reduce the circumference of the annulus, thereby reducing valve regurgitation.
As illustrated in
For some applications, implant 1210 and/or delivery tool 1250 is as described in one or more of the following references, mutatis mutandis, each of which is incorporated by reference in its entirety:
Similarly to the method described hereinabove with reference to system 500, prior to driving each anchor 1220 into the tissue at a potential anchoring site, device 520 is used to identify whether the potential anchoring site is suitable (e.g., whether the potential anchoring site is indeed on the annulus). As in system 500, the anchor is used as a first electrode, and an anchor driver 1260, which is used to drive the anchor into the tissue, may also be used to electrically connect data-processing system 521 (not shown) to the anchor. Similarly to the application shown in
For some applications in which contracting member 1212 is electrically conductive, it may be advantageous to electrically isolate anchors 1220 from the contraction member—e.g., in order to reduce electrical signals from being conducted (e.g., from previously-anchored anchors), along the contracting member to the anchor that is presently engaged by the driver, via which device 520 is electrically connected to the anchor that is presently engaged by the driver. For example, eyelets 1240 may comprise and/or be coated with an electrically-insulating material. However, it has been determined that data-processing system 521 is typically capable of determining the position of the presently-engaged anchor even in the absence of such insulation.
During anchoring of an anchor 1220, the known (e.g., fixed) distance between second electrode 1140 and the respective anchor may advantageously assist in the derivation of the refined signal. For example, data-processing system 521 may not need to recalibrate between anchoring of the anchors, as the distance between the second electrode and each anchor being anchored is fixed. It is to be understood that the applications described hereinabove with reference to
Reference is again made to
In addition, the second electrode may also be electrically disconnected from data-processing system 521 following implantation of implant 222. For example, in applications in which contracting mechanism 40 serves as the second electrode (e.g., as shown in
For applications for which the second electrode is disposed at a distal part of delivery tool 510 (e.g., second electrode 140 as shown in
Reference is now made to
In order to determine direct contact between the anchor-head and the tissue surface, a tissue-facing electrode disposed at the tissue-facing surface of the anchor-head serves as a detecting electrode, from which the data-processing system of the sensing device receives an electrical signal, e.g., an ECG signal. Once the tissue-facing surface of the anchor-head comes into 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 the anchor driver, e.g., as described hereinabove, mutatis mutandis.
For some applications, the electrical signal detected by the tissue-facing electrode is simply the electrophysiological signal produced by the heart, such that the tissue-facing electrode serves as a sensing electrode to detect electrical activity produced by the heart. Additionally or alternatively, an exogenous electrical signal may be provided for this purpose (e.g., via a reference electrode placed outside of the heart of the subject).
The anchor comprises a tissue-engaging element that is adapted to be driven into the tissue, and an anchor-head that has a tissue-facing surface that, once the tissue-engaging element has been fully driven into the tissue, contacts the tissue surface. The anchor is typically delivered to the heart and driven into the tissue using the anchor driver that is engaged with the anchor-head, e.g., as described hereinabove, mutatis mutandis.
Typically, the data-processing system runs a program in which the electrical signal obtained by the tissue-facing electrode serves as an input, and which responsively determines whether there is contact between the anchor-head and the tissue surface. For some applications, artificial intelligence and/or machine learning is employed in the building of the program. For example, building of the program may be facilitated by the artificial intelligence analyzing data (e.g., a labeled data set) of electrical signals (e.g., such electrical signals and/or other ECG data obtained from previously performed procedures). For some applications, in order to train (e.g., further train) the program, the location outputted intra-procedurally by the program is compared to the actual position of the anchor with respect to the tissue surface (e.g., determined by other means).
For some applications, determining contact between the anchor-head and the tissue may additionally or alternatively be used to determine whether the anchor has been driven into the tissue at an undesirable angle (e.g., oblique with the surface of tissue 11), rather than at an angle substantially perpendicular to the tissue (e.g., such that the anchor-head is generally parallel with the tissue).
For some applications, the data-processing system is adapted to determine whether the angle of attack falls within a predetermined range of angles-of-attack, and to responsively provide an output (e.g., an alert), should the determination be indicative of the angle of attack falling outside the predetermined range. Thus for some applications, the data-processing system only alerts the operator should the angle-of-attack be outside the predetermined range.
For some applications, the data-processing system is adapted to provide such an indication of anchor-driving angle—e.g., by determining whether the anchor head lies parallel with the tissue. For some such applications, the anchor may have multiple tissue-facing electrodes disposed along the tissue-facing surface of the anchor-head in a manner which facilitates such functionality. For example, receiving an electrical signal from only a subset of the tissue-facing electrodes may be indicative that the anchor extends into the tissue at an angle oblique to the surface of the tissue, and therefore only part of the tissue-facing surface of the anchor head is in contact with the tissue. Similarly, receiving an electrical signal from all of the tissue-facing electrodes may be indicative that the anchor extends into the tissue substantially orthogonally to the surface of the tissue, and therefore substantially all of the tissue-facing surface is in contact with the tissue.
For some applications, an amount by which the anchor has been driven into the tissue is determined and compared to the data-processing system's determination and/or indication of contact between the anchor head and the tissue surface. For example, should it be determined that contact has been made between the anchor-head and the tissue-surface earlier than would be expected from the amount by which the anchor has been driven into the tissue (e.g., for an anchor that has a helical tissue-engaging element, as would be expected from the number of rotations of the anchor), this may be indicative that the anchor has been driven into the tissue at an undesirably shallow angle.
With regard to the previous paragraph, the amount by which the anchor has been driven into the tissue may be determined simply by the operator—e.g., counting rotations of the anchor driver, or observing fluoroscopically. Alternatively or additionally, the amount by which the anchor has been driven into the tissue may be determined by the data-processing system—e.g., responsively to receiving signals indicative of a response of the tissue to the driving of the tissue-engaging element into the tissue, e.g., as described hereinbelow, such as with reference to
For some applications, the anchor driver is lockable to the anchor-head in a manner that places the tissue-facing electrode in electrical communication with the data-processing system without placing the tissue-engaging element in electrical communication with the data-processing system (i.e., such that the tissue-engaging element is electrically isolated from the data-processing system)—e.g., such that contact between the anchor-head and the tissue is distinguishable from contact between the tissue-engaging element and the tissue. Various applications for achieving the electrical isolation of the tissue engaging element from the data-processing system are described with respect to
Anchor-head 2004 has a tissue-facing surface 2008 that may itself serve as the tissue-facing electrode. For example, anchor driver 2236 may be in electrical communication with tissue-facing surface 2008, such that placing the tissue-facing surface against the surface of tissue 11 provides an electrical communication between the tissue and data-processing system 2521. For some such applications, the entire anchor-head 2004 may be electrically conductive (e.g., constructed from a metallic material and/or coated with an electrically conductive coating), such that the anchor-head serves as the conductor between tissue-facing surface 2008 and the anchor driver 2236, via which the electrical signal is relayed to data-processing system 2521. Thus, for some applications, tissue-facing surface 2008 may not be distinct from other parts of the anchor-head.
For some applications, tissue-engaging element 2002 may be electrically non-conductive, such that only upon anchor-head 2004 contacting tissue 11 (e.g., only upon the tissue-facing electrode contacting the tissue), is data-processing system 2521 in electrical contact with the tissue. For example, tissue-engaging element 2002 may be formed from an insulating material, and/or may be coated in an insulating material.
As illustrated in
Device 3520 typically comprises a data-processing system 3521 (e.g., a processor), which may combine the functionality of data-processing systems 521 and 2521, such that it is adapted to both (i) provide, at least during a first phase of the anchoring process of anchor 3006 (
In such applications, data-processing system 3521 is electrically connected (i) to a tissue-engaging element 3002 of the anchor, which serves as an electrode used for locating the anchor, as described with reference to
Thus, for such applications, tissue-engaging element 3002 serves as a “locator-electrode,” and the electrode at the tissue-facing surface of the anchor-head serves as a “head-contact electrode.”
For some applications, one or both of first connection 3101 and second connection 3102 are provided at least in part by anchor driver 3236. For example, first connection 3101 may be partly provided by a wire 3111 that is electrically connected to tissue-engaging element 3002 (e.g., via an electrically conductive inner core 3004c of the anchor head). Similarly, second connection 3102 may be partly provided by the shaft of anchor driver 3236 (e.g., via an electrical connection between the shaft and outer layer 3004a).
For some applications, wire 3111 may additionally serve as an actuator that controls locking/unlocking of driver 3236 from anchor head 3004. For example, wire 3111 may serve a similar (e.g., identical) function to rod 130, described hereinabove. Similarly, rod 130 may serve as wire 3111, mutatis mutandis.
Thus, as is shown in
For some applications, electrical isolation between the electrodes of anchor head 3004 is provided in order to electrically isolate the signals received such that, during the second phase of anchoring, any signal received via tissue-engaging element 3002 does not preclude determination of contact between the anchor-head and the tissue surface. For some applications, this isolation is provided via an insulating layer 3004b, which may be as described for insulating layer 2004b. Similarly, wire 3111 may be electrically isolated from the shaft of anchor driver 3236 and/or from electrode 3004a (e.g., may extend through an insulated aperture in anchor-head 3004 (e.g., a variant of the insulated aperture described with reference to
It is to be understood that the first phase and the second phase could be performed sequentially or concurrently by a single data-processing system 3521. Alternatively, two data-processing systems (e.g., data-processing systems 521 and 2521) could be used during the anchoring process, such that first connection 3101 is electrically connected to data-processing system 521 (for use during the first phase of anchoring), and second connection 3102 is connected to data-processing system 2521 (for use during the second phase of anchoring).
A technique for assessing whether an anchor is being driven into tissue of the annulus is now described, in accordance with some applications. For some applications, subsequently to determining that an anchor is contacting tissue of the annulus (e.g., using the methods described hereinabove), it is advantageous to continuously assess, during driving of the anchor into the tissue, whether the anchor is being anchored correctly (e.g., into the correct tissue and/or at a favorable orientation and/or that the anchor is penetrating tissue, and is not suspended in the bloodstream, and/or that the anchor has been driven into the tissue to the required depth). For example, the data-processing system may continue to receive the first signal, the second signal, and/or the refined signal (described hereinabove), and may perform a continuous determination in response to one or more of these signals.
Different tissues of the heart may respond differently to the anchoring process, such that a data-processing system (e.g., as described hereinabove) can provide an indication of the location and/or positioning of the anchor within the tissue, responsively to the electrical signal detected by the anchor as it is driven into the tissue.
The electrical signal detected by the anchor may change as the tissue-engaging element passes into solid tissue, and the resulting electrical signal may therefore be indicative of the location of the anchor within the heart. For example, electrocardiogramaf the subject during the anchoring process has resulted in the observation that when a tissue anchor is driven into heart tissue of the subject, a temporary electrocardiogramange, e.g., an abnormality such as an ectopic beat, a premature impulse (e.g., a premature ventricular contraction (PVC), and/or a premature atrial contraction (PAC)), typically occurs. The electrocardiogramange typically occurs when while the anchor is placed in contact with the tissue or driven into the tissue, or shortly thereafter (e.g., within 5 seconds and/or 5 heartbeats of the driving of the anchor). The PVC may be initiated by, and indicative of, the distal end of the tissue-engaging element of the tissue anchor penetrating heart muscle tissue (e.g., of the ventricle) after having passed all the way through the annulus. Furthermore, an absence of the abnormality (e.g., the PVC) at the time of anchoring a tissue anchor may be indicative of the tissue-engaging element not having penetrated the heart muscle tissue. For some applications it is advantageous for the distal end of the tissue-engaging element to pass all the way through the annulus.
The technique thus includes using the anchor as an electrode to detect the electrophysiological signals produced by the heart as the anchor is driven into the tissue, and, responsively to the electrical signal, providing an indication of the location of the anchor within the heart. It is to be understood that this indication of the location of the anchor may be (i) an indication regarding the orientation of the anchor within the heart (e.g., the angle-of-attack of the anchor with respect to the tissue into which the anchor is being driven), and/or (ii) an indication regarding the location of the anchor along an atrioventricular axis of the heart, and/or (iii) an indication regarding a plurality of locations through which the anchor is passing as it is being driven into the tissue (e.g., the depth of the anchor within the annulus).
It Due to the different electrical responses of the different tissues of the heart to the anchoring process, should the anchor be inadvertently driven into the heart at a suboptimal location and/or angle and/or depth (e.g., other than into the annulus from the atrium), the electrical signal may differ to that shown in
Typically, the data-processing system runs a program in which at least one of the first, second, and refined signals (as described hereinabove) serves as an input, and which responsively determines the location of anchor as it is being driven into the heart.
For some applications, artificial intelligence and/or machine learning is employed in the building of the program. For example, building of the program may be facilitated by the artificial intelligence analyzing data (e.g., a labeled data set) that may include (e.g., refined signals, first signals, second signal, and/or other ECG data obtained from previously performed procedures). For some applications, in order to train (e.g., further train) the program, the location outputted intra-procedurally by the program is compared to the actual location of the anchor (e.g., determined by other means).
Reference is now made to
With reference to
With reference to
For each of delivery tools 4250 and 5250, the distal part of the delivery tool comprises multiple electrodes. Each of these delivery tools is electrically connectable to a data-processing system (e.g., a processor)—e.g., may belong to a system that includes the data-processing system, or may simply be compatible with the data-processing system. The data-processing system receives signals from each of the multiple electrodes, responsively to the signals determines an orientation of the distal part of the delivery tool, and provides an output (e.g., a visual and/or audible output) indicative of the orientation. For example, the data-processing system may comprise means, such as hardware and/or software, for performing this method. For some applications, the output is provided via a display, such as described hereinabove. For some applications, the data-processing system is a component of a sensing (and/or procedure-aiding) device, such as described hereinabove. For some applications, the data-processing system is the same data-processing system as one described hereinabove—e.g., a single data-processing system (e.g., a single sensing and/or procedure-aiding device) executes more than one of the techniques described herein.
Although the electrodes of delivery tools 4250 and 5250 are shown and described as being disposed on catheters 4252 and 5252 of the delivery tools (e.g., the catheters out of which anchor 1220 is to be driven), it is to be understood that the scope of the present disclosure includes the electrodes being disposed on other components of the delivery tools, such as, but not limited to, the anchor driver of the delivery tools (i.e., the anchor driver that is engaged with anchor 1220 and that drives the anchor into the tissue—e.g., by applying torque to the anchor). Furthermore, it is to be understood that the scope of the present disclosure includes applying, to delivery tools and systems described elsewhere herein, features described for delivery tools 4250 and 5250 and the systems to which they belong.
At the distal part of delivery tool 4250, multiple electrodes are disposed on catheter 4252. In the example shown, the multiple electrodes are a first electrode 4140 and a second electrode 4142—but it is to be understood that a greater number of electrodes may be used. Electrodes 4140 and 4142 may be distributed axially along the distal part of the delivery tool (e.g., of the catheter). Each of these electrodes may be a ring electrode that, at its respective axial position, circumscribes the distal part of delivery tool. Described hereinabove, in the context of other systems, are techniques for determining the position of an electrode (e.g., an anchor serving as an electrode) within the heart—e.g., along an atrioventricular axis of the heart. By applying such techniques, mutatis mutandis, to determine the position of each of the multiple electrodes, the orientation of the distal part of the delivery tool (e.g., of the catheter) may be determined—e.g., as a straight line that passes through each of the positions.
For some applications, the orientation determined by the data-processing system is an orientation with respect to atrioventricular axis ax2. At least one of the positions determined may be a position along atrioventricular axis ax2 of the heart. In the example shown, a position p1 of first electrode 4140 along atrioventricular axis ax2 is determined, as is a position p2 of the second electrode along the atrioventricular axis. Responsively to positions p1 and p2 (e.g., responsively to a difference (e.g., a distance) therebetween), the data-processing system may determine the orientation of the distal part of delivery tool 4250 (e.g., of catheter 4252) with respect to atrioventricular axis ax2. For example, the determination may be made responsively to (a) the determined difference between the positions of the electrodes within the heart, and (b) a known/predetermined distance between (i) a first electrode-site at which electrode 4140 is disposed on the distal part of the delivery tool, and (ii) a second electrode-site at which electrode 4142 is disposed on the distal part of the delivery tool. A greater determined p1-p2 distance may indicate (e.g., may be determined to represent) a shallower orientation with respect to atrioventricular axis ax2.
At the distal part of delivery tool 5250, multiple electrodes are disposed on catheter 5252. In the example shown, the multiple electrodes are a first electrode 5140, a second electrode 5142, and a third electrode 5144—but it is to be understood that two electrodes, or four or more electrodes, may be used. Electrodes 5140, 5142, and 5414 may be distributed circumferentially around the distal part of the delivery tool (e.g., of the catheter). Each of these electrodes may be disposed at the same axial position along the distal part of the catheter—e.g., the electrodes may be arranged in a circumferential row.
For some applications, the orientation determined by the data-processing system is an orientation with respect to the surface of the tissue into which anchor 1220 is to be driven. From each of electrodes 5140, 5142, and 5414, a respective signal may be received by the data-processing system. Responsively to the signals, the data-processing system may determine the orientation of the distal part of delivery tool 5250 (e.g., of catheter 5252) with respect to the surface of the tissue. At least one of the signals may be indicative a proximity of the corresponding electrode to a surface of the tissue—e.g., a proximity of the nearest tissue surface, alternatively defined as the shortest distance to a tissue surface. An electrical signal may be applied to the tissue (e.g., between anchor 1220 and each of electrodes 5140, 5142, and 5414), and the data-processing system may determine the orientation of the difference between the signals detected via each of electrodes 5140, 5142, and 5414. For example, the data-processing system may determine a proximity of each of electrodes 5140, 5142, and 5414 to the surface of the tissue, and may determine the orientation responsively to differences between these proximities. A greater difference between the signals may indicate (e.g., may be determined to represent) a shallower orientation with respect to the surface of the tissue, whereas little or no difference may indicate that the distal portion of delivery tool 5250 is transverse (e.g., head on) to the surface of the tissue.
The signal may be (or may be detected as) a bioimpedance signal—e.g., may be indicative of bioimpedance of the tissue(s) through which the electrical signal is driven. This may be applied, for example, based on differences in bioimpedance between blood, annulus tissue, leaflet tissue, and/or myocardium.
Reference is again made to
Reference is again made to
For some applications, responsively to the initial signal(s) the data-processing system narrows (e.g., refines) the data set being used (e.g., by categorizing the subject and, based on the categorization, selecting an appropriate narrower data set from a range of narrower data sets). This may be performed as the delivery tool is being advanced to the heart, prior to the actual intracardiac procedure. Subsequently, the intra-procedure analysis of the endogenous signals that facilitates intracardiac navigation is based on the narrower (e.g., selected) data set, and therefore may advantageously be more accurate in its determination of location due to narrower data set being more representative of the subject being treated.
Reference is again made to
Reference is again made to
Reference is again made to
In the present disclosure, the term data-processing system may refer to, be part of, or include an Application Specific Integrated Circuit (ASIC); a digital, analog, or mixed analog/digital discrete circuit; a digital, analog, or mixed analog/digital integrated circuit; a combinational logic circuit; a field programmable gate array (FPGA); a processor (shared, dedicated, group) that executes code; memory (shared, dedicated, or group) that stores code executed by a processor; other suitable hardware components, such as optical, magnetic, or solid state drives, that provide the described functionality; or a combination of some or all of the above, such as in a system-on-chip. The term code, as used above, may include software, firmware, and/or microcode, and may refer to programs, routines, algorithms, functions, classes, and/or objects. The term shared processor encompasses a single processor that executes some or all code from multiple modules. The term group processor encompasses a processor that, in combination with additional circuitry (e.g., processors), executes some or all code from one or more modules. The term shared memory encompasses a single memory that stores some or all code from multiple modules. The term group memory encompasses a memory that, in combination with additional memories, stores some or all code from one or more modules. The term memory may be subset of the term computer-readable medium. The term computer-readable medium does not encompass transitory electrical and electromagnetic signals propagating through a medium, and may therefore be considered tangible and non-transitory. Non-limiting examples of a non-transitory tangible computer readable medium include nonvolatile memory, volatile memory, magnetic storage, and optical storage.
It is to be noted that, although the apparatus and techniques described herein are shown in the figures on the left side of the heart (e.g., at the mitral valve), the apparatus and techniques described herein may similarly be used on the right side of the heart (e.g., at the tricuspid valve), mutatis mutandis.
It is to be noted that, although implants 222 and 1210 are shown as annuloplasty implants, the technology described herein may be used to facilitate implantation of other implants, mutatis mutandis, such as other implants that are anchored to the annulus of an atrioventricular valve, e.g., such as some leaflet-restraining and/or leaflet-manipulating implants. For example, the technology described herein may be used to facilitate anchoring of one or more of the implants (e.g., implant 100 and variants thereof) described in International Patent Application PCT/US2021/039587 to Chau et al., which published as WO 2022/006087, and which is incorporated herein by reference.
Although the systems and techniques described herein are generally described as being for use with a human subject, any of the techniques, methods, operations, steps, etc. described or suggested herein can be performed on a non-human animal or on a non-living simulation, such as a cadaver, a cadaver heart, an anthropomorphic ghost, and/or a simulator device (which may include computerized and/or physical representations of body parts, tissue, etc.).
Although the operations of some of the disclosed methods are described in a particular, sequential order for convenient presentation, it should be understood that this manner of description encompasses rearrangement, unless a particular ordering is required by specific language set forth below. For example, operations described sequentially can in some cases be rearranged or performed concurrently. Moreover, for the sake of simplicity,
Example Applications (some non-limiting examples of the concepts herein are recited below):
Example 1. A system for use with a heart of a subject, the system comprising: an anchor;
Example 2. The system according to example 1, wherein the data-processing system is adapted to receive the first electrical signal, receive the second electrical signal, determine the location, and provide the output, prior to the delivery tool driving the anchor into the tissue.
Example 3. The system according to any one of examples 1-2, wherein the anchor is a helical anchor.
Example 4. The system according to any one of examples 1-3, wherein:
Example 5. The system according to example 4, wherein the data-processing system is adapted to receive the first initial electrical signal and the second initial electrical signal prior to the delivery tool delivering the anchor to the heart.
Example 6. The system according to any one of examples 1-5, wherein:
Example 7. The system according to example 6, wherein:
Example 8. The system according to example 6, wherein:
Example 9. The system according to any one of examples 1-8, wherein:
Example 10. The system according to any one of examples 1-9, wherein the data-processing system is adapted to, subsequently to the delivery tool delivering the anchor to the heart:
Example 11. The system according to any one of examples 1-10, wherein the data-processing system is adapted to determine the location of the anchor within the heart by determining a difference between the first signal and the second signal.
Example 12. The system according to any one of examples 1-11, wherein the data-processing system is adapted to, subsequently to providing the output indicative of the location of the anchor within the heart, and while the anchor is driven into the tissue:
Example 13. The system according to any one of examples 1-12, wherein the anchor has a tissue-engaging element and a head, and wherein the data-processing system is adapted to, subsequently to providing the output indicative of the location of the anchor within the heart, and while the anchor is driven into the tissue:
Example 14. The system according to any one of examples 1-13, wherein:
Example 15. The system according to example 14, wherein the driver is disengageable from the anchor within the heart.
Example 16. The system according to example 14, wherein:
Example 17. The system according to example 14, wherein:
Example 18. The system according to any one of examples 1-17, wherein:
Example 19. The system according to example 18, wherein the distal part of the guide member is mechanically and electrically connected to the contracting mechanism, and wherein the data-processing system is adapted to, subsequently to the delivery tool delivering the anchor to the heart, receive the second electrical signal from the distal part of the guide member that is mechanically and electrically connected to the contracting mechanism.
Example 20. The system according to example 18, further comprising a sensing device that comprises the data-processing system and a connector, the connector being electrically and mechanically connectable to a proximal part of the guide member in a manner that configures the data-processing system to receive the second signal from the distal part of the guide member via the connector.
Example 21. The system according to example 20, wherein the connector is a crocodile clip that is clippable onto the proximal part of the guide member.
Example 22. The system according to example 20, wherein the distal part of the guide member is mechanically and electrically connected to the contracting mechanism, and wherein the connector is electrically and mechanically connectable to the proximal part of the guide member in a manner that configures the data-processing system to receive the second signal from the contracting mechanism via the guide member and the connector.
Example 23. The system according to example 22, wherein, subsequently to actuation of the contracting mechanism by the adjustment tool, the guide member is intracorporeally disconnectable from the contracting mechanism such that the contracting mechanism, within the heart, becomes electrically isolated from the data-processing system.
Example 24. The system according to any one of examples 1-23, wherein the anchor defines a distal tip, adapted to penetrate tissue of the heart, and wherein the data-processing system is adapted to receive the first signal while the distal tip of the anchor is placed against the tissue.
Example 25. The system according to example 24, wherein, the data-processing system is adapted to receive the first signal while the distal tip of the anchor is placed against a surface of the tissue of the heart, not penetrating the tissue.
Example 26. The system according to example 24, further comprising a sleeve adapted to be anchored to the tissue by the anchor, and wherein the data-processing system is adapted to receive the first signal while the sleeve is sandwiched between the distal tip and a surface of the tissue.
Example 27. The system according to example 24, wherein, the data-processing system is adapted to receive the first signal while the distal tip of the anchor is disposed within the tissue, having penetrated the tissue.
Example 28. The system according to any one of examples 1-27, further comprising a sensing device that comprises the data-processing system and a first connector, the first connector being electrically and mechanically connectable to a proximal part of the delivery tool, thereby configuring the data-processing system to receive the first signal from the anchor via the first connector.
Example 29. The system according to example 28, wherein the first connector is a crocodile clip that is clippable onto the proximal part of the delivery tool.
Example 30. The system according to example 28, wherein the sensing device further comprises a second connector, the second connector being electrically and mechanically connectable to a proximal portion of the delivery tool, thereby configuring the data-processing system to receive the second signal from the distal part of the delivery tool via the second connector.
Example 31. The system according to example 30, wherein the second connector is a crocodile clip that is clippable onto the proximal part of the delivery tool.
Example 32. The system according to example 30, wherein the second connector is an electronic snap.
Example 33. The system according to any one of examples 1-32, wherein:
Example 34. The system according to example 33, wherein:
Example 35. The system according to any one of examples 1-34, wherein:
Example 36. The system according to example 35, wherein the second electrode is disposed on a lateral wall of a catheter of the delivery tool.
Example 37. The system according to example 36, wherein:
Example 38. The system according to example 37, wherein:
Example 39. The system according to example 35, wherein the data-processing system is adapted to receive the second signal while the second electrode is suspended in a bloodstream of the heart.
Example 40. The system according to example 35, wherein the data-processing system is adapted to receive the second signal while the second electrode does not contact the tissue of the heart.
Example 41. The system according to any one of examples 1-40, further comprising a reference electrode, adapted to be placed outside of the heart of the subject, wherein the data-processing system is configured to determine the location, facilitated by the reference electrode.
Example 42. The system according to example 41, wherein the reference electrode is a skin electrode, adapted to be placed on skin of the subject.
Example 43. A system for use with a heart of a subject, the system comprising:
Example 44. A system for use with a heart of a subject, the system comprising:
Example 45. The system according to example 44, wherein the data-processing system is adapted to receive the first electrical signal, receive the second electrical signal, determine the location, and provide the output, prior to the delivery tool driving the anchor into the tissue.
Example 46. The system according to any one of examples 44-45, wherein the data-processing system is adapted to, subsequently to providing the output indicative of the location of the anchor within the heart, and while the anchor is driven into the tissue:
Example 47. The system according to any one of examples 44-46, wherein the anchor has a tissue-engaging element and a head, and wherein the data-processing system is adapted to, subsequently to providing the output indicative of the location of the anchor within the heart, and while the tissue-engaging element is driven into the tissue:
Example 48. The system according to any one of examples 44-47, wherein:
Example 49. The system according to any one of examples 44-48, wherein the data-processing system is adapted to receive the second signal while the contracting mechanism is suspended in a bloodstream of the heart.
Example 50. The system according to any one of examples 44-49, wherein the data-processing system is adapted to receive the second signal while the contracting mechanism does not contact the tissue of the heart.
Example 51. The system according to any one of examples 44-50, wherein the data-processing system is adapted to, subsequently to the driver delivering the anchor to the heart:
Example 52. The system according to any one of examples 44-51, wherein the data-processing system is adapted to determine the location of the anchor within the heart by determining a difference between the first signal and the second signal.
Example 53. The system according to any one of examples 44-52, further comprising a sensing device that comprises the data-processing system and a first connector, the first connector being electrically and mechanically connectable to a proximal part of the driver, thereby configuring the data-processing system to receive the first signal from the anchor via the first connector.
Example 54. The system according to example 53, wherein the first connector is a crocodile clip that is clippable onto the proximal part of the driver.
Example 55. The system according to example 53, wherein the first connector is an electronic snap.
Example 56. The system according to any one of examples 44-55, wherein the system further comprises:
Example 57. The system according to example 56, further comprising a sensing device that comprises the data-processing system and a connector, the connector being electrically and mechanically connectable to a proximal part of the guide member in a manner that configures the data-processing system to receive the second signal from the contracting mechanism via the guide member and the connector.
Example 58. The system according to example 57, wherein the connector is a crocodile clip that is clippable onto the proximal part of the guide member.
Example 59. The system according to example 56, wherein, subsequently to actuation of the contracting mechanism by the adjustment tool, the guide member is intracorporeally disconnectable from the contracting mechanism such that the contracting mechanism, within the heart, becomes electrically isolated from the data-processing system.
Example 60. The system according to any one of examples 44-59, wherein the driver is disengageable from the anchor within the heart.
Example 61. The system according to example 60, wherein:
Example 62. The system according to example 60, wherein:
Example 63. The system according to any one of examples 44-62, wherein the anchor defines a distal tip, adapted to penetrate tissue of the heart, and wherein the data-processing system is adapted to receive the first signal while the distal tip of the anchor is placed against the tissue.
Example 64. The system according to example 63, wherein, the data-processing system is adapted to receive the first signal while the distal tip of the anchor is placed against a surface of the tissue of the heart, not penetrating the tissue.
Example 65. The system according to example 63, wherein the implant further comprises a sleeve adapted to be anchored to the tissue by the anchor, and wherein the data-processing system is adapted to receive the first signal while the sleeve is sandwiched between the distal tip and a surface of the tissue.
Example 66. The system according to example 63, wherein, the data-processing system is adapted to receive the first signal while the distal tip of the anchor is disposed within the tissue, having penetrated the tissue.
Example 67. The system according to any one of examples 44-66, wherein:
Example 68. The system according to example 67, wherein:
Example 69. The system according to any one of examples 44-68, further comprising a reference electrode, adapted to be placed outside of the heart of the subject, wherein the data-processing system is configured to determine the location, facilitated by the reference electrode.
Example 70. The system according to example 69, wherein the reference electrode is a skin electrode, adapted to be placed on skin of the subject.
Example 71. A system for use at a heart of a subject, the system comprising: an anchor comprising:
Example 72. The system according to example 71, wherein the driver is adapted to drive the tissue-engaging element into the tissue such that the tissue-facing electrode becomes pressed against the surface of the tissue without penetrating the tissue.
Example 73. The system according to any one of examples 71-72, wherein the anchor is electrically disconnectable from the data-processing system subsequently to driving the tissue-engaging element into the tissue, by disengaging the driver from the anchor-head.
Example 74. The system according to any one of examples 71-73, wherein the anchor-head defines a tissue-facing surface, and wherein the tissue-facing surface serves as the tissue-facing electrode.
Example 75. The system according to example 74, wherein the driver is adapted to drive the tissue-engaging element into the tissue such that the tissue-facing surface becomes pressed against the surface of the tissue without penetrating the tissue.
Example 76. The system according to example 74, wherein the anchor-head is formed from an electrically conductive material, and wherein the data-processing system is adapted to receive the electrical signal from the tissue-facing surface, via the anchor-head.
Example 77. The system according to any one of examples 71-76, wherein the tissue-engaging element is electrically isolated from the data-processing system.
Example 78. The system according to example 77, wherein the tissue-engaging element is electrically isolated from the data-processing system by the tissue-engaging element being electrically isolated from the tissue-facing electrode.
Example 79. The system according to example 78, wherein the anchor-head comprises:
Example 80. The system according to any one of examples 71-79, further comprising a sensing device that comprises the data-processing system and a connector, the connector being electrically and mechanically connectable to a proximal part of the driver, thereby configuring the data-processing system to receive the electrical signal from the tissue-facing electrode via the connector.
Example 81. The system according to example 80, wherein the connector is a crocodile clip that is clippable onto the proximal part of the driver.
Example 82. The system according to example 80, wherein the connector is an electronic snap.
Example 83. The system according to any one of examples 71-82, wherein the driver is disengageable from the anchor-head within the heart.
Example 84. The system according to example 83, wherein:
Example 85. The system according to example 83, wherein:
Example 86. The system according to any one of examples 71-85, further comprising a reference electrode, adapted to be placed outside of the heart of the subject, wherein the data-processing system is configured to determine contact between the anchor-head and the tissue surface, facilitated by the reference electrode.
Example 87. The system according to example 86, wherein the reference electrode is a skin electrode, adapted to be placed on skin of the subject.
Example 88. A system for use at a heart of a subject, the system comprising: an anchor comprising:
Example 89. The system according to example 88, wherein the data-processing system is adapted to, responsively to the electrical signal, determine an angle of attack of the anchor with respect to the tissue.
Example 90. A device for use with (i) an anchor, and (ii) a delivery tool comprising an anchor driver adapted to transluminally drive the anchor into tissue of a heart of a subject, the device comprising:
Example 91. The device according to example 90, further comprising a third wire electrically and mechanically connected to a reference electrode adapted to be placed outside of the heart of the subject, wherein the data-processing system is adapted to:
Example 92. The device according to any one of examples 90-91, wherein the data-processing system is adapted to:
Example 93. The device according to any one of examples 90-92, further comprising a third wire electrically and mechanically connected to a reference electrode adapted to be placed outside of the heart of the subject, wherein the data-processing system is adapted to:
Example 94. A system for use at a heart of a subject, the system comprising: an implant adapted to reduce regurgitation of a valve of the heart;
Example 95. The system according to example 94, wherein the anchor is a helical anchor.
Example 96. The system according to any one of examples 94-95, wherein:
Example 97. The system according to any one of examples 94-96, wherein:
Example 98. The system according to any one of examples 94-97, wherein the data-processing system is further adapted to, responsively to the electrical signal, determine an angle of attack of the anchor with respect to the tissue.
Example 99. The system according to any one of examples 94-98, wherein the data-processing system is further adapted to, responsively to the electrical signal, determine a depth of the anchor within the tissue.
Example 100. The system according to any one of examples 94-99, further comprising a sensing device that comprises the data-processing system and a connector, the connector being electrically and mechanically connectable to a proximal part of the driver, thereby configuring the data-processing system to receive the electrical signal from the anchor via the connector.
Example 101. The system according to example 100, wherein the connector is a crocodile clip that is clippable onto the proximal part of the driver.
Example 102. The system according to example 100, wherein the first connector is an electronic snap.
Example 103. The system according to any one of examples 94-102, wherein:
Example 104. The system according to example 103, further comprising a sensing device that comprises the data-processing system and a connector, the connector being electrically and mechanically connectable to a proximal part of the guide member in a manner that configures the data-processing system to receive the second signal from the distal part of the guide member via the connector.
Example 105. The system according to example 103, wherein, subsequently to actuation of the contracting mechanism by the adjustment tool, the guide member is intracorporeally disconnectable from the contracting mechanism such that the contracting mechanism, within the heart, becomes electrically isolated from the data-processing system.
Example 106. The system according to example 103, wherein the data-processing system is adapted to receive the second signal while the contracting mechanism does not contact the tissue of the heart.
Example 107. The system according to example 103, wherein the data-processing system is adapted to, during the tissue-engaging element being driven into the tissue:
Example 108. The system according to any one of examples 94-107, wherein the driver is disengageable from the anchor within the heart.
Example 109. The system according to example 108, wherein:
Example 110. The system according to example 108, wherein:
Example 111. The system according to any one of examples 94-110, wherein:
Example 112. The system according to example 111, wherein:
Example 113. The system according to any one of examples 94-112, further comprising a reference electrode, adapted to be placed outside of the heart of the subject, wherein the data-processing system is configured to determine the location, facilitated by the reference electrode.
Example 114. The system according to example 113, wherein the reference electrode is a skin electrode, adapted to be placed on skin of the subject.
Example 115. A system for use at a heart of a subject, the system comprising: an implant adapted to reduce regurgitation of a valve of the heart;
Example 116. The system according to example 115, wherein:
Example 117. The system according to example 116, wherein the data-processing system is adapted to, responsively to the angle of attack, provide an indication of the angle of attack.
Example 118. The system according to example 116, wherein the data-processing system is adapted to:
Example 119. A system for use with an anchor and for use at a heart of a subject, the system comprising:
Example 120. The system according to example 119, wherein the first electrical signal is an endogenous electrical signal, and the data-processing system is configured to receive the endogenous electrical signal from the first electrode.
Example 121. The system according to 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.
Example 122. The system according to any one of examples 119-121, wherein the first electrode and the second electrode are distributed axially along the distal part.
Example 123. The system according to any one of examples 119-122, wherein the first electrode and the second electrode are distributed circumferentially around the distal part.
Example 124. The system according to any one of examples 119-123, wherein:
Example 125. The system according to any one of examples 119-124, wherein:
Example 126. The system according to example 125, wherein determining the orientation comprises determining the orientation responsively to (a) a difference between the position of the first electrode within the heart and the position of the second electrode within the heart, and (b) a distance between (i) a first electrode-site at which the first electrode is disposed on the distal part, and (ii) a second electrode-site at which the second electrode is disposed on the distal part.
Example 127. The system according to example 125, wherein:
Example 128. The system according to example 127, wherein:
Example 129. The system according to example 125, wherein:
Example 130. The system according to example 129, wherein:
Example 131. The system according to any one of examples 119-130, wherein:
Example 132. The system according to example 119, wherein:
Example 133. The system according to example 119, wherein:
Example 134. A computer-implemented method, comprising:
Example 135. The method according to example 134, wherein the first electrical signal is an endogenous electrical signal, and receiving the first electrical signal comprises receiving the endogenous electrical signal.
Example 136. The method according to example 134, wherein the first electrical signal is an exogenous electrical signal, the method further comprises applying the exogenous electrical signal, and receiving the first electrical signal comprises receiving the exogenous electrical signal.
Example 137. The method according to any one of examples 134-136, wherein:
Example 138. A data-processing apparatus comprising means for carrying out the steps of the method of any one of examples 134-137.
Example 139. A computer program comprising instructions which, when the program is executed by a computer, cause the computer to carry out the method of any one of examples 134-137.
Example 140. A computer-readable medium having stored thereon the computer program of example 139.
Example 141. A computer-implemented method, comprising:
Example 142. The method according to example 141, wherein:
Example 143. The method according to example 141, wherein:
Example 144. A computer-implemented method for use with a heart of a subject,
Example 145. A computer-implemented method for use with a heart of a subject,
Example 146. A data-processing apparatus comprising means for carrying out the steps of the method of any one of examples 141-145.
Example 147. A computer program comprising instructions which, when the program is executed by a computer, cause the computer to carry out the method of any one of examples 141-145.
Example 148. A computer-readable medium having stored thereon the computer program of example 147.
It will be appreciated by persons skilled in the art that the present invention is not limited to what has been particularly shown and described hereinabove. Rather, the scope of the present invention includes both combinations and subcombinations of the various features described hereinabove, as well as variations and modifications thereof that are not in the prior art, which would occur to persons skilled in the art upon reading the foregoing description.
This application is a continuation of International Patent Application No. PCT/IB2023/050073, filed Jan. 5, 2023, which claims the benefit of U.S. Patent Application No. 63/298,199, filed Jan. 10, 2022, the entire disclosures all of which are incorporated by reference for all purposes. Each of the above applications is incorporated herein by reference.
| Number | Date | Country | |
|---|---|---|---|
| 63298199 | Jan 2022 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | PCT/IB2023/050073 | Jan 2023 | WO |
| Child | 18767781 | US |
