Systems and methods for transluminally advancing an implant toward an anatomical site of a subject

Abstract

A system for delivering and securing an implant to tissue at an anatomical site includes a first catheter (20), a second catheter (40), an implant (70), and a delivery tool (60). The second catheter has a handle (42) with a proximal portion (45) extending distally therefrom, a steerable portion (46) continuing distally from the proximal portion, and a distal portion (48) continuing distally from the steerable portion, such that the second catheter defines a continuous lumen through the proximal, steerable, and distal portions. The second catheter is configured to be advanced toward the anatomical site via the first lumen of the first catheter such that the steerable portion becomes exposed distally out of the first lumen. The delivery tool is adapted to extend through the continuous lumen, to advance the implant out of the second catheter, and to secure the implant to tissue at the anatomical site.

Description

SYSTEMS AND METHODS FOR TRANSLUMINALLY ADVANCING AN IMPLANT TOWARD AN ANATOMICAL SITE OF A SUBJECTCROSS REFERENCE TO RELATED APPLICATIONS

[0001] The present application claims priority to U.S. Provisional Application Ser. No.63 / 755,225, filed on Feb. 6, 2025, titled SYSTEMS AND METHODS FOR TRANSLUMINALLY ADVANCING AN IMPLANT TOWARD AN ANATOMICAL SITE OF A SUBJECT, the disclosure of which is incorporated herein by reference in its entirety.BACKGROUND

[0002] Various implants can be used within anatomical sites of subjects, such as within the heart, in treatment of common maladies. Such implants can be delivered into the anatomical sites using steerable catheters able to navigate through vasculature of the subject. Pre-shaped sheaths may be used to deliver an implant to the body cavity in a particular orientation.

[0003] Steerable catheters for delivery of implants through the vasculature of a subject may require an ability to be steered in three dimensions, so as to get through bends in the vasculature and at the anatomical site. Nesting multiple steerable catheters may help with navigation in multiple dimensions, but the external catheter must be sufficiently wide to accommodate additional nested catheter(s) and a delivery tool, resulting in the external catheter having a large diameter that may be unsuitable for passage through narrower vasculature.

[0004] There is thus a need for improved techniques and devices for steering of catheters, in three dimensions, for delivery of an implant via the vasculature of a subject to an anatomical site thereof.SUMMARY

[0005] This summary is meant to provide some examples and is not intended to be limiting of the scope of the invention in any way. For example, any feature included in an example of this summary is not required by the claims, unless the claims explicitly recite the features. Also, the features, components, steps, concepts, etc. described in examples in this summary and elsewhere in this disclosure can be combined in a variety of ways. Various features andsteps as described elsewhere in this disclosure may be included in the examples summarized here.

[0006] In accordance with some implementations, a system for use with a subject includes a catheter. The catheter includes a steerable portion adapted to be steered in a desired direction. In some implementations, the catheter includes an extendable portion. In some implementations, the extendable portion is distal to the steerable portion.

[0007] In some implementations, the steerable portion is adapted to be steered in a single plane, to point a distal end of the catheter in a desired operative direction.

[0008] In some implementations, the extendable portion is adapted to be extended or contracted, by a suitable extension and contraction mechanism, to change a length of the catheter. In some implementations, the extension and contraction of the extendable portion change the placement of the distal end of the catheter along the desired operative direction, but do not change the direction to which the catheter is steered.

[0009] In some implementations, the catheter can further include a handle, attached to a proximal end of a flexible tube including the steerable portion and the extendable portion. In some implementations, the handle includes a steering-control functionally associated with the steerable portion. In some implementations, when the steering-control is engaged by a user, the steerable portion of the catheter is deflected in a specified direction.

[0010] In some implementations, the handle further includes an extension-control, functionally associated with the extendable portion. In some implementations, hen the extension-control is engaged by the user, the length of the extendable portion of the catheter is modified (e.g., extended or contracted).

[0011] In some implementations, the catheter is an inner catheter, and the system further includes an outer catheter. In some such implementations, the inner catheter is advanceable, into the body of the subject, slidably through the outer catheter.

[0012] In some implementations, the system can further include an implant to be delivered into the body of the subject, and a delivery tool, adapted to engage the implant and to advance the implant into the body of the subject via the catheter.

[0013] In accordance with some implementations, a system for use with a subject (e.g., a living subject and / or a simulation) includes a first catheter.

[0014] In some implementations, the first catheter has a proximal end, and a distal end that is configured to be transluminally advanced toward an anatomical site of the subject.

[0015] In some implementations, the first catheter defines a first lumen between the proximal end and the distal end.

[0016] In some implementations, the system can further include a second catheter.

[0017] In some implementations, the second catheter has a handle, a proximal portion extending distally from the handle, a steerable portion continuing distally from the proximal portion, and a distal portion continuing distally from the steerable portion to point in an operative direction.

[0018] In some implementations, the second catheter defines a continuous lumen through the proximal, steerable, and distal portions, the lumen terminating at a distal opening at the distal portion of the second catheter, the distal opening facing in the operative direction.

[0019] In some implementations, the second catheter is configured to be advanced toward the anatomical site via the first lumen of the first catheter, such that the steerable portion becomes exposed distally out of the first lumen.

[0020] In some implementations, the handle of the second catheter includes a steeringcontrol and an extension-control.

[0021] In some implementations, at least in part via operative coupling between the steerable portion and the steering-control, the steerable portion is configured to, responsively to operation of the steering-control, deflect the distal portion to change the operative direction.

[0022] In some implementations, at least in part via operative coupling between the distal portion and the extension-control, the distal portion is configured to, responsively to operation of the extension-control, alter its length as measured between the steerable portion and the distal opening.

[0023] In some implementations, the system can further include an implant.

[0024] In some implementations, the system can further include a delivery tool.

[0025] In some implementations, the delivery tool can be adapted to extend through the continuous lumen, to advance the implant out of the distal opening, and to secure the implant to tissue at the anatomical site.

[0026] In some implementations, the first catheter has a distal steerable region.

[0027] In some implementations, the first catheter has a first handle.

[0028] In some implementations, the proximal end of the first catheter is coupled to the first handle.

[0029] In some implementations, the first handle includes a steering knob such that at least in part via operative coupling between the distal steerable portion of the first catheter and the steering knob, the distal steerable portion of the first catheter is configured to be deflected responsively to operation of the steering knob.

[0030] In some implementations, the distal steerable portion of the first catheter is steerable in a first plane, perpendicular to a longitudinal axis of the distal portion of the second catheter, and the steerable portion of the second catheter is steerable in a second plane, perpendicular to the first plane and perpendicular to the longitudinal axis of the distal portion of the second catheter.

[0031] In some implementations, advancement of the second catheter through the first lumen brings the handle of the second catheter into proximity of the first handle of the first catheter.

[0032] In some implementations, advancement of the second catheter through the first lumen causes coupling of the handle of the second catheter to the first handle of the first catheter, thereby to form a proximal handle portion.

[0033] In some implementations, the handle of the second catheter and the first handle of the first catheter have a locked state, inhibiting rotation of the proximal portion of the second catheter within the first lumen.

[0034] In some implementations, the second catheter is slidable through the first catheter.

[0035] In some implementations, the distal portion of the second catheter has a contracted state in which the distal portion has a first length and an extended state in which the distal portion has a second length, longer than the first length, the first and second lengths being measured between a distal end of the steerable portion of the second catheter and the distal opening of the second catheter.

[0036] In some implementations, an external diameter of the distal portion is substantially fixed in the contracted state.

[0037] In some implementations, an external diameter of the distal portion is substantially fixed in the extended state.

[0038] In some implementations, an external diameter of the distal portion is substantially equal in the contracted and extended states.

[0039] In some implementations, the distal portion of the second catheter is at rest in the contracted state, and is extended to the extended state responsively to user manipulation of the extension-control.

[0040] In some implementations, the second catheter further includes an extension spring extending through the distal portion, the extension spring adapted to have a contracted rest state.

[0041] In some implementations, the second catheter further includes a spring extension mechanism, functionally associated with the extension-control, such that user manipulation of the extension-control causes the spring extension mechanism to apply force to the extension spring to cause extension thereof, thereby causing extension of the distal portion to assume the second length.

[0042] In some implementations, the spring extension mechanism includes a pneumatic mechanism, functionally associated with a distal end of the extension spring and with the extension-control .

[0043] In some implementations, user manipulation of the extension-control in a first manner causes pneumatic extension of the pneumatic mechanism, resulting in application of force, in a distal direction, to the distal end of the extension spring, resulting in extension of the extension spring and in the distal portion of the second catheter assuming the second length.

[0044] In some implementations, user manipulation of the extension-control in a second manner causes contraction of the pneumatic mechanism, releasing the force from the distal end of the extension spring, and allowing the extension spring to return to the contracted rest state, resulting in the distal portion of the second catheter reassuming the first length.

[0045] In some implementations, the spring extension mechanism includes a hydraulic mechanism, functionally associated with a distal end of the extension spring and with the extension-control .

[0046] In some implementations, user manipulation of the extension-control in a first manner causes hydraulic extension of the hydraulic mechanism, resulting in application of force, in a distal direction, to the distal end of the extension spring, resulting in extension ofthe extension spring and in the distal portion of the second catheter assuming the second length.

[0047] In some implementations, user manipulation of the extension-control in a second manner causes contraction of the hydraulic mechanism, releasing the force from the distal end of the extension spring, and allowing the extension spring to return to the contracted rest state, resulting in the distal portion of the second catheter reassuming the first length.

[0048] In some implementations, the spring extension mechanism includes a pushing rod extending through the second catheter, the pushing rod being functionally associated with a distal end of the extension spring and with the extension-control.

[0049] In some implementations, user manipulation of the extension-control in a first manner causes distal motion of the pushing rod resulting in application of force, in a distal direction, to the distal end of the extension spring, resulting in extension of the extension spring and in the distal portion of the second catheter assuming the second length.

[0050] In some implementations, user manipulation of the extension-control in a second manner causes proximal motion of the extension rod, releasing the force from the distal end of the extension spring, and allowing the extension spring to return to the contracted rest state, resulting in the distal portion of the second catheter reassuming the first length.

[0051] In some implementations, the distal portion of the second catheter is at rest in the extended state, and is contracted to the contracted state responsively to user manipulation of the extension-control.

[0052] In some implementations, the second catheter further includes a compression spring extending through the distal portion, the compression spring adapted to have an extended rest state.

[0053] In some implementations, the second catheter further includes a spring compression mechanism, functionally associated with the extension-control, such that user manipulation of the extension-control causes the spring compression mechanism to apply force to the compression spring, in a proximal direction, to cause compression thereof, thereby causing compression of the distal portion from the second length to assume the first length.

[0054] In some implementations, the spring compression mechanism includes a tether extending through the second catheter, the tether being functionally associated with a distal end of the compression spring and with the extension-control.

[0055] In some implementations, user manipulation of the extension-control in a first manner causes pulling of the tether in a proximal direction, resulting in application of force, in a proximal direction, to the distal end of the compression spring, resulting in compression of the compression spring and in the distal portion of the second catheter assuming the first length.

[0056] In some implementations, user manipulation of the extension-control in a second manner causes release of the tether, releasing the force from the distal end of the compression spring, and allowing the compression spring to return to the extended rest state, resulting in the distal portion of the second catheter reassuming the second length.

[0057] In some implementations, the distal portion of the second catheter is devoid of steering ability.

[0058] In some implementations, external diameters of the steerable portion and of the distal portion of the second catheter are substantially equal.

[0059] In some implementations, the implant includes a tissue anchor, and the delivery tool includes an anchor driver.

[0060] In some implementations, the implant includes a plurality of tissue anchors adapted to be driven by the anchor driver, and wherein the handle of the second catheter includes a plurality of chambers adapted to accommodate the plurality of tissue anchors.

[0061] In accordance with some implementations herein, a catheter configured to be transluminally advanced toward an anatomical site of a subject (e.g., a living subject, a simulation, etc.) includes a handle. In some implementations, the handle includes a steeringcontrol. In some implementations, the handle includes an extension-control.

[0062] In some implementations, the catheter can further include a proximal portion extending distally from the handle.

[0063] In some implementations, the catheter can further include a steerable portion continuing distally from the proximal portion.

[0064] In some implementations, the catheter can further include a distal portion continuing distally from the steerable portion to point in an operative direction.

[0065] In some implementations, the catheter can further include a continuous lumen defined through the proximal, steerable, and distal portions, the lumen terminating at a distalopening at the distal portion of the second catheter, the distal opening facing in the operative direction.

[0066] In some implementations, at least in part via operative coupling between the steerable portion and the steering-control, the steerable portion is configured to, responsively to operation of the steering-control, deflect the distal portion to change the operative direction.

[0067] In some implementations, at least in part via operative coupling between the distal portion and the extension-control, the distal portion is configured to, responsively to operation of the extension-control, alter its length as measured between the steerable portion and the distal opening.

[0068] In some implementations, the proximal, steerable, and distal portions are adapted to be slidable through a delivery catheter toward the anatomical site.

[0069] In some implementations, the distal portion has a contracted state in which the distal portion has a first length and an extended state in which the distal portion has a second length, longer than the first length, the first and second lengths being measured between the steerable portion and the distal opening.

[0070] In some implementations, an external diameter of the distal portion is substantially fixed in the contracted state.

[0071] In some implementations, an external diameter of the distal portion is substantially fixed in the extended state.

[0072] In some implementations, an external diameter of the distal portion is substantially equal in the contracted and extended states.

[0073] In some implementations, the distal portion is at rest in the contracted state, and is extended to the extended state responsively to user manipulation of the extension-control.

[0074] In some implementations, the catheter can further include an extension spring extending through the distal portion, the extension spring adapted to have a contracted rest state.

[0075] In some implementations, the catheter can further include a spring extension mechanism, functionally associated with the extension-control, such that user manipulation of the extension-control causes the spring extension mechanism to apply force to the extension spring to cause extension thereof, thereby causing extension of the distal portion to assume the second length.

[0076] In some implementations, the spring extension mechanism includes a pneumatic mechanism, functionally associated with a distal end of the extension spring and with the extension-control .

[0077] In some implementations, user manipulation of the extension-control in a first manner causes pneumatic extension of the pneumatic mechanism, resulting in application of force, in a distal direction, to the distal end of the extension spring, resulting in extension of the extension spring and in the distal portion assuming the second length.

[0078] In some implementations, user manipulation of the extension-control in a second manner causes contraction of the pneumatic mechanism, releasing the force from the distal end of the extension spring, and allowing the extension spring to return to the contracted rest state, resulting in the distal portion reassuming the first length.

[0079] In some implementations, the spring extension mechanism includes a hydraulic mechanism, functionally associated with a distal end of the extension spring and with the extension-control .

[0080] In some implementations, user manipulation of the extension-control in a first manner causes hydraulic extension of the hydraulic mechanism, resulting in application of force, in a distal direction, to the distal end of the extension spring, resulting in extension of the extension spring and in the distal portion assuming the second length.

[0081] In some implementations, user manipulation of the extension-control in a second manner causes contraction of the hydraulic mechanism, releasing the force from the distal end of the extension spring, and allowing the extension spring to return to the contracted rest state, resulting in the distal portion reassuming the first length.

[0082] In some implementations, the spring extension mechanism includes a pushing rod extending through the second catheter, the pushing rod being functionally associated with a distal end of the extension spring and with the extension-control.

[0083] In some implementations, user manipulation of the extension-control in a first manner causes distal motion of the pushing rod resulting in application of force, in a distal direction, to the distal end of the extension spring, resulting in extension of the extension spring and in the distal portion assuming the second length.

[0084] In some implementations, user manipulation of the extension-control in a second manner causes proximal motion of the extension rod, releasing the force from the distal endof the extension spring, and allowing the extension spring to return to the contracted rest state, resulting in the distal portion reassuming the first length.

[0085] In some implementations, the distal portion is at rest in the extended state, and is contracted to the contracted state responsively to user manipulation of the extension-control.

[0086] In some implementations, the catheter can further include a compression spring extending through the distal portion, the compression spring adapted to have an extended rest state.

[0087] In some implementations, the catheter can further include a spring compression mechanism, functionally associated with the extension-control, such that user manipulation of the extension-control causes the spring compression mechanism to apply force to the compression spring, in a proximal direction, to cause compression thereof, thereby causing compression of the distal portion from the second length to assume the first length.

[0088] In some implementations, the spring compression mechanism includes a tether extending through the second catheter, the tether being functionally associated with a distal end of the compression spring and with the extension-control.

[0089] In some implementations, user manipulation of the extension-control in a first manner causes pulling of the tether in a proximal direction, resulting in application of force, in a proximal direction, to the distal end of the compression spring, resulting in compression of the compression spring and in the distal portion assuming the first length.

[0090] In some implementations, user manipulation of the extension-control in a second manner causes release of the tether, releasing the force from the distal end of the compression spring, and allowing the compression spring to return to the extended rest state, resulting in the distal portion reassuming the second length.

[0091] In some implementations, the distal portion is devoid of steering ability.

[0092] In some implementations, external diameters of the steerable portion and of the distal portion are substantially equal.

[0093] In some implementations, the catheter is adapted for delivery of a plurality of tissue anchors to the anatomical site, and wherein the handle includes a plurality of chambers adapted to accommodate the plurality of tissue anchors.

[0094] There is additionally provided, in accordance with some implementations herein, a system for use with a subject. The system includes a first catheter.

[0095] In some implementations, the first catheter has a proximal end, and a distal end that is configured to be transluminally advanced toward an anatomical site of the subject.

[0096] In some implementations, the first catheter defines a first lumen between the proximal end and the distal end.

[0097] In some implementations, the system can further include a second catheter.

[0098] In some implementations, the second catheter has a handle, a proximal portion extending distally from the handle, a steerable portion continuing distally from the proximal portion, and a distal portion continuing distally from the steerable portion to point in an operative direction.

[0099] In some implementations, the second catheter defines a continuous lumen through the proximal, steerable, and distal portions, the lumen terminating at a distal opening at the distal portion of the second catheter, the distal opening facing in the operative direction.

[0100] In some implementations, the second catheter is configured to be advanced toward the anatomical site via the first lumen such that the steerable portion becomes exposed distally out of the first lumen.

[0101] In some implementations, the handle includes a steering-control.

[0102] In some implementations, at least in part via operative coupling between the steerable portion and the steering-control, the steerable portion is configured to, responsively to operation of the steering-control, deflect the distal portion to change the operative direction.

[0103] In some implementations, the distal portion is elastic and includes at least one inwardly-extending protrusion.

[0104] In some implementations, the system can further include an implant.

[0105] In some implementations, the system can further include a delivery tool, adapted to extend through the continuous lumen, to advance the implant out of the distal opening, and to secure the implant to tissue at the anatomical site.

[0106] In some implementations, during advancement of the delivery tool and the implant in a distal direction, the implant or the delivery tool is adapted to apply force to the at least one inwardly-facing protrusion, thereby to extend a length of the distal portion of the second catheter as measured between a distal end of the steerable portion of the second catheter and the distal opening of the second catheter, from a first length to a second length.

[0107] In some implementations, the first catheter can further have a distal steerable portion.

[0108] In some implementations, the first catheter can further have a first handle, the proximal end of the first catheter being coupled to the first handle, the first handle including a steering knob such that at least in part via operative coupling between the distal steerable portion of the first catheter and the steering knob, the distal steerable portion of the first catheter is configured to be deflected responsively to operation of the steering knob.

[0109] In some implementations, the distal steerable portion of the first catheter is steerable in a first plane, perpendicular to a longitudinal axis of the distal portion of the second catheter, and the steerable portion of the second catheter is steerable in a second plane, perpendicular to the first plane and perpendicular to the longitudinal axis of the distal portion of the second catheter.

[0110] In some implementations, advancement of the second catheter through the first lumen brings the handle of the second catheter into proximity of the first handle of the first catheter.[oni] In some implementations, advancement of the second catheter through the first lumen causes coupling of the handle of the second catheter to the first handle of the first catheter, thereby to form a proximal handle portion.

[0112] In some implementations, the handle of the second catheter and the first handle of the first catheter have a locked state, inhibiting rotation of the proximal portion of the second catheter within the first lumen.

[0113] In some implementations, the second catheter is slidable through the first catheter.

[0114] In some implementations, the distal portion of the second catheter has a contracted rest state in which the distal portion has the first length and an extended state in which the distal portion has the second length.

[0115] In some implementations, an external diameter of the distal portion is substantially fixed in the contracted state.

[0116] In some implementations, an external diameter of the distal portion is substantially fixed in the extended state.

[0117] In some implementations, an external diameter of the distal portion is substantially equal in the contracted and extended states.

[0118] In some implementations, the distal portion of the second catheter is devoid of steering ability.

[0119] In some implementations, external diameters of the steerable portion and of the distal portion of the second catheter are substantially equal.

[0120] In some implementations, the implant includes a tissue anchor, and the delivery tool includes an anchor driver.

[0121] In some implementations, the implant includes a plurality of tissue anchors adapted to be driven by the anchor driver, and wherein the handle of the second catheter includes a plurality of chambers adapted to accommodate the plurality of tissue anchors.

[0122] There is additionally provided, in accordance with some implementations herein, a catheter configured to be transluminally advanced toward an anatomical site of a subject, for advancement of an implant and a delivery tool toward the anatomical site through the catheter.

[0123] In some implementations, the catheter can include a handle including a steeringcontrol.

[0124] In some implementations, the catheter can include a proximal portion extending distally from the handle.

[0125] In some implementations, the catheter can include a steerable portion continuing distally from the proximal portion.

[0126] In some implementations, the catheter can include an elastic distal portion continuing distally from the steerable portion to point in an operative direction, the elastic distal portion including at least one inwardly-extending protrusion.

[0127] In some implementations, the catheter can include a continuous lumen defined through the proximal, steerable, and distal portions, the lumen terminating at a distal opening at the distal portion of the second catheter, the distal opening facing in the operative direction.

[0128] In some implementations, at least in part via operative coupling between the steerable portion and the steering-control, the steerable portion is configured to, responsively to operation of the steering-control, deflect the distal portion to change the operative direction.

[0129] In some implementations, during advancement of the delivery tool and the implant in a distal direction toward the distal opening, the implant or the delivery tool is adapted to apply force to the at least one inwardly-facing protrusion, thereby to extend a length of the distal portion as measured between the steerable portion and the distal opening, from a first length to a second length.

[0130] In some implementations, the proximal, steerable, and distal portions are adapted to be slidable through a delivery catheter toward the anatomical site.

[0131] In some implementations, the distal portion has a contracted rest state in which the distal portion has the first length and an extended state in which the distal portion has the second length.

[0132] In some implementations, an external diameter of the distal portion is substantially fixed in the contracted state.

[0133] In some implementations, an external diameter of the distal portion is substantially fixed in the extended state.

[0134] In some implementations, an external diameter of the distal portion is substantially equal in the contracted and extended states.

[0135] In some implementations, the distal portion is devoid of steering ability.

[0136] In some implementations, external diameters of the steerable portion and of the distal portion are substantially equal.

[0137] In some implementations, the catheter is adapted for delivery of a plurality of tissue anchors to the anatomical site, and wherein the handle includes a plurality of chambers adapted to accommodate the plurality of tissue anchors.

[0138] There is additionally provided, in accordance with some implementations herein, a method, including transluminally advancing a first catheter toward a real or simulated anatomical site of a real or simulated subject, the first catheter defining a first lumen extending between a proximal end and a distal end of the first catheter.

[0139] In some implementations, the method can further include slidably advancing a second catheter through the first lumen of the first catheter, the second catheter including a handle, a proximal portion extending distally from the handle, a steerable portion continuing distally from the proximal portion, and / or a distal portion continuing distally from the steerable portion. In some implementations, the second catheter defines a continuous lumenfrom the handle through the proximal, steerable, and distal portions. In some implementations, the lumen terminates at a distal opening of the second catheter.

[0140] In some implementations, slidably advancing includes slidably advancing the second catheter through the first lumen such that the steerable and distal portions of the second catheter extend distally out of the first lumen.

[0141] In some implementations, the method can include steering the steerable portion of the second catheter to deflect the distal portion to face an operative direction.

[0142] In some implementations, the method can further include altering a length of the distal portion in the operative direction, as measured between the steerable portion and the distal opening.

[0143] In some implementations, the method can further include advancing the delivery tool and the implant through the continuous lumen, so the implant extends out of the distal opening.

[0144] In some implementations, the method can further include using the delivery tool, securing the implant to tissue at the anatomical site.

[0145] In some implementations, the first catheter includes a distal steerable portion, and the transluminally advancing of the first catheter includes steering the distal steerable portion of the first catheter.

[0146] In some implementations, the steering of the first distal steerable portion of the first catheter is in a first plane, perpendicular to a longitudinal axis of the distal portion of the second catheter, and the steering of the steerable portion of the second catheter is in a second plane, perpendicular to the first plane and perpendicular to the longitudinal axis of the distal portion of the second catheter.

[0147] In some implementations, the first catheter further includes a first handle, and the advancing of the second catheter through the first lumen includes bringing the handle of the second catheter into proximity of the first handle of the first catheter.

[0148] In some implementations, the first catheter further includes a first handle, and the advancing of the second catheter through the first lumen includes coupling the handle of the second catheter to the first handle of the first catheter, thereby to form a proximal handle portion.

[0149] In some implementations, the first catheter further includes a first handle, and the advancing of the second catheter through the first lumen includes locking the handle of the second catheter to the first handle of the first catheter, thereby to inhibit rotation of the proximal portion of the second catheter within the first lumen.

[0150] In some implementations, the altering of the length of the distal portion of the second catheter includes extending the distal portion from a first length to assume a second length, longer than the first length.

[0151] In some implementations, the extending includes applying force in a distal direction to an extension spring, disposed within the distal portion of the second catheter, thereby to extend a length of the extension spring and as a result to extend the length of the distal portion.

[0152] In some implementations, the applying force includes using a pneumatic mechanism to apply the force to the extension spring.

[0153] In some implementations, the applying force includes using a hydraulic mechanism to apply the force to the extension spring.

[0154] In some implementations, the applying force includes using a pushing rod to apply the force to the extension spring.

[0155] In some implementations, the altering of the length of the distal portion of the second catheter includes contracting the distal portion from a second length to assume a first length, shorter than the second length.

[0156] In some implementations, the contracting includes applying force in a proximal direction to a distal end of a compression spring, disposed within the distal portion of the second catheter, thereby to compress the compression spring and as a result to contract the length of the distal portion.

[0157] In some implementations, the applying force in the proximal direction includes pulling on a tether functionally associated with the distal end of the compression spring.

[0158] Any of the techniques, methods, operations, steps, etc. described or suggested herein can be performed on a living animal (e.g., human, other mammal, etc.) or on a non-living simulation, such as a cadaver, a cadaver heart, an anthropomorphic ghost, and / or a simulator device (which may include computerized and / or physical representations of body parts, tissue, etc.).

[0159] The various systems, devices, apparatuses, etc. in this disclosure can be sterilized (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure they are safe for use with patients, and the methods herein can comprise such sterilization of the associated system, device, apparatus, etc. Furthermore, the scope of the present disclosure includes, for some applications, sterilizing one or more of any of the various systems, devices, apparatuses, etc. in this disclosure.

[0160] The foregoing discussion will be understood more readily from the following detailed description when taken in conjunction with the accompanying Figures, in which:BRIEF DESCRIPTION OF THE FIGURES

[0161] Fig. 1 A is a schematic illustration of a system for delivery of an implant to a target anatomical site, in accordance with some implementations;

[0162] Fig. IB is a schematic illustration of a catheter forming part of the system of Fig. 1 A, in accordance with some implementations;

[0163] Figs. 2A-2E are schematic illustrations of steps of delivery and implantation of an implant at the heart of a subject, using a system in accordance with some implementations;

[0164] Figs. 3A-3E are schematic illustrations of an extension mechanism of a second catheter forming part of the system of Figs. 1A and IB, in accordance with some implementations;

[0165] Figs. 4A-4E are schematic illustrations of a variant extension mechanism of a second catheter forming part of the system of Figs. 1A and IB, in accordance with some implementations; and

[0166] Figs. 5 A-5E are schematic illustrations of another variant extension mechanism of a second catheter forming part of the system of Figs. 1A and IB, in accordance with some implementations.DETAILED DESCRIPTION

[0167] Principles of apparatus and methods for transluminally advancing an implant to a target anatomical site may be better understood with reference to the drawings and the following description.

[0168] In the following description, various aspects of the disclosure will be described. For the purpose of explanation, specific configurations and details are set forth in order to provide a thorough understanding of the different aspects of the disclosure. However, it will also be apparent to one skilled in the art that the disclosure may be practiced without specific details being presented herein. Furthermore, well-known features can be omitted or simplified in order not to obscure the disclosure. Additionally, in order to avoid undue clutter from having too many reference numbers and lead lines on a particular drawing, some elements may not be explicitly identified in every drawing that contains that element.

[0169] It is to be understood that the scope of the invention is not limited in its implementation to the details of construction and the arrangement of the components set forth in the following description or illustrated in the drawings. The invention is capable of other implementations or of being practiced or carried out in various ways. Furthermore, it is to be understood that the phraseology and terminology employed in the disclosure is for the purpose of description and should not be regarded as limiting.

[0170] The present disclosure includes different variants of some elements. Variants of a given element typically have the same structure and / or function as each other except for any differences described. For any given element for which different variants are disclosed, the identical name is used for each variant, in order to denote that they are, in fact, variants the same given element. Unless stated otherwise, applications of the devices, systems, and techniques described herein may include any arrangement in which one variant of an element is substituted with another identically-named variant of that element. Furthermore, throughout the figures, suffixes are used to denote different variants of the same element. Unless stated otherwise, such variants may be substituted with each other, mutatis mutandis. That is, unless stated otherwise, any element having a given reference numeral may be substituted with any other element (i.e. any other variant of the element) having the same reference numeral, independent of any suffix.

[0171] For the purposes of this implementation, the term “subject” relates to any mammal, particularly humans.

[0172] For the purposes of this implementation, the term “cardiac tissue” relates to any tissue of the heart, and includes, for example, any wall of the heart and any tissue of any heart valve.

[0173] Referring now to the drawings, Fig. 1 A is a schematic illustration of a system 10 for delivery of an implant to a target anatomical site. Fig. IB is a schematic illustration of an inner catheter forming part of system 10.

[0174] System 10 is a catheter system that comprises at least one catheter, as well as a delivery tool and / or an adjustment tool. In the example shown, system 10 comprises a first, or outer, catheter 20 and a second, or inner, catheter 40, each of which has an extracorporeal handle (22 and 42, respectively) and a flexible tube (24 and 44, respectively). Catheter 40 is shown in Fig. IB, in addition to being included in Fig. 1 A.

[0175] As seen in Fig. 1A, Flexible tube 24 of catheter 20 has a proximal portion 25, physically coupled to and extending distally from extracorporeal handle 22 and a distal end that is configured to be transluminally advanced toward an anatomical site of the subject, such that a first lumen is defined between the proximal end and the distal end. In some implementations, flexible tube 24 can have a distal steerable portion 26 (i.e., i.e., a portion that is actively deflectable) that is operatively coupled to extracorporeal handle 22 (e.g., via one or more pull wires) such that steering of the steerable portion can be effected by operation of a steering knob 28 of the extracorporeal handle (e.g., one or more user interfaces or controllers thereof, such as knobs).

[0176] In some implementations, e.g., in which system 10 is used for heart valve repair or other treatment, catheter 20 can be transluminally advanced to a chamber adjacent the heart valve (e.g., an atrium upstream of the heart valve), e.g., such that the distal end of tube 24 reaches the chamber, as explained in further detail hereinbelow. In some implementations, the distal steerable portion of catheter 20 is steerable in a single dimension.

[0177] As seen in Figs. 1 A and IB, Flexible tube 44 of catheter 40 has a proximal portion 45, physically coupled to and extending distally from extracorporeal handle 42, a steerable portion 46 (i.e., i.e., a portion that is actively deflectable) continuing distally from the proximal portion, and a distal portion 48 continuing distally from the steerable portion to point in an operative direction. In some implementations, the proximal, steerable, and distal portions of tube 44 define a continuous lumen, the lumen terminating at a distal opening 50 at the distal portion of catheter 40, which opening faces in the operative direction.

[0178] In some implementations, extracorporeal handle 42 includes a steering-control 56 and an extension-control 58. In some implementations, the steerable portion of tube 44 is operatively coupled to steering control 56 of extracorporeal handle 42 (e.g., via one or morepull wires) such that steering of the steerable portion 46 can be effected by operation of the extracorporeal handle (e.g., one or more user interfaces or controllers thereof, such as knobs). In some implementations, steerable portion 46 is configured, responsive to operation of steering-control 56, to deflect distal portion 48 of tube 44 to change the operative direction thereof.

[0179] In some implementations, distal portion 48 of tube 44 is operatively coupled to extension-control 58 of extracorporeal handle 42. In some implementations, distal portion 48 of tube 44 is configured, responsive to operation of extension-control 58, to alter its length as measured between steerable portion 46 and distal opening 50. Specifically, distal portion 48 is adapted to extend and contract, along a longitudinal axis thereof, so as to increase and decrease a distance between steerable portion 46 and distal opening 50.

[0180] In some implementations, distal portion 48 of flexible tube 44 is devoid of steering ability.

[0181] In some implementations, within flexible tube 44, a diameter of distal portion 48 is equal to a diameter of steerable portion 46.

[0182] In some implementations, an external diameter of distal portion 48 is fixed, along a longitudinal length thereof, in the extended state of the distal portion.

[0183] In some implementations, an external diameter of distal portion 48 is fixed, along a longitudinal length thereof, in the contracted state of the distal portion.

[0184] In some implementations, catheter 40 can be transluminally advanced such that the steerable portion and the distal portion of tube 44 exit the distal end of tube 24, and face and / or approaches the tissue to which an implant 70 is to be implanted. For some implementation, catheter 40 is slidable through the lumen of catheter 20.

[0185] In some implementations, catheters 20 and 40 can be advanced with tube 44 already disposed through tube 24. In some implementations, tube 44 can be advanced through tube 24 after the distal end of tube 24 is already in (or at least close to) the heart chamber.

[0186] In some implementations, system 10 can further comprise a support assembly 66, configured to support catheter 20, catheter 40, and / or other components described hereinbelow. In some implementations, the support assembly and techniques for use thereof, can be as described, or similar to aspects of those described in International Patent Application publication WO 2024 / 121770 to Halabi et al., and / or International PatentApplication publication WO 2014 / 064694 to Sheps et al., each of which is incorporated herein by reference in its entirety.

[0187] In some implementations, system 10 comprises a delivery tool, for implanting an implant 70, that can comprise a catheter device. In the example shown, system 10 comprises a delivery tool 60 comprising an operative end 62 disposed at a distal end of a flexible tube 64, adapted to extend through the continuous lumen of flexible tube 44, to advance implant 70 out of the distal opening of catheter 40, and to secure the implant to tissue at the anatomical site. In some implementations, and as shown, delivery tool 60 comprises an anchor driver 110.

[0188] In some implementations, extracorporeal handle 42 of catheter 40 can include a plurality of chambers 49 configured to accommodate a corresponding plurality of implants 70, or of portions of an implant 70, such as tissue anchors. In some implementations, and as explained in further detail herein, the delivery tool 60 may be configured to sequentially deliver each of the plurality of implants 70 via flexible tube 44 of catheter 40.

[0189] In some implementations, tube 64 is transluminally advanced along with one or more of the catheters 20 and / or 40 (e.g., while already extended through the one or more catheters). In some implementations, tube 64 is advanced through the one or more of the catheters after the catheters have already been transluminally advanced to the heart.

[0190] In some implementations, advancement of catheter 40 through catheter 20 brings extracorporeal handle 42 into proximity with extracorporeal handle 22. In some implementations, extracorporeal handles 22 and 42 are coupled to each other to define a proximal handle portion 80. In some implementations, for example within proximal handle portion 80, extracorporeal handles 22 and 42 have a locked state inhibiting rotation of tube 44 within tube 24.

[0191] Reference is now made to Figs. 2A-2E, which are schematic illustrations of steps of delivery and implanting of an annul oplasty ring structure 100 to treat a valve by repairing mitral valve 102, using system 10, in accordance with some implementations. This procedure is one exemplary procedure that can be performed using system 10. In some implementations, the procedure, treatment, etc. can be used on other valves, e.g., a tricuspid valve, etc. In some implementations, the treatment may comprise replacing the native valve (e.g., with a prosthetic valve) instead of or in addition to the example procedure described here. The features can be incorporated into a variety of systems for a variety of uses.

[0192] Annul oplasty structure 100 is used to repair a dilated valve annulus of an atrioventricular valve, such as mitral valve 102. In some implementations, annul oplasty structure 100 functions as implant 70, and is configured to be placed only partially around the valve annulus (e.g., to assume a C-shape), and, once anchored in place, to be contracted so as to circumferentially tighten the valve annulus. Annul oplasty structure 100 comprises a plurality of anchors 104, having a tether 106 disposed therebetween. An anchor driver 110, functioning as delivery tool 60, drives the anchors into cardiac tissue, thereby anchoring the sleeve around a portion of the valve annulus. Subsequently, the tether can be adjusted, for example by tightening thereof. Examples of such procedures that, mutatis mutandis, may be facilitated by system 10 (e.g., features of catheter 40 thereof), include those described in one or more of the following publications, each of which is incorporated herein by reference in its entirety:International Patent Application publication WO 2013 / 069019 to Sheps et al. International Patent Application publication WO 2014 / 064694 to Sheps et al. International Patent Application publication WO 2016 / 174669 to Iflah et al. International Patent Application publication WO 2024 / 121770 to Halabi et al.

[0193] In some implementations, anchors 104 of annul oplasty structure 100 can be accommodated in chambers 49 of handle 42 of catheter 40, as illustrated in Figs. 1 A and IB. In some such implementations, anchor driver 110 sequentially picks up anchors 104 from their accommodating chambers, and drives the anchors into the cardiac tissue, as explained herein.

[0194] As shown in Fig. 2A, first catheter 20 is advanced into the left atrium 120 of the heart of a subject, and second catheter 40 is advanced through first catheter 20, until distal portion 48 and at least part of steerable portion 46 of second catheter 40 extend out of the distal end of first catheter 20.

[0195] In some implementations, catheters 20 and 40 may be advanced into left atrium 120 using any methodology known in the art, for example over a semirigid guidewire. The procedure is typically performed with the aid of imaging, such as fluoroscopy, transesophageal echo, and / or echocardiography.

[0196] In some implementations, catheters 20 and 40 are advanced through vasculature into the left atrium using a suitable point of origin typically determined for a given patient. For example:

[0197] In some implementations, catheters 20 and 40 may be introduced into the femoral vein of the patient, through an inferior vena cava, into right atrium 122, and into a left atrium 120 transseptally, typically through the fossa ovalis.

[0198] In some implementations, catheters 20 and 40 may be introduced into the basilic vein, through the subclavian vein to the superior vena cava, into right atrium 122, and into left atrium 120 transseptally, typically through the fossa ovalis; or

[0199] In some implementations, catheters 20 and 40 may be introduced into the external jugular vein, through the subclavian vein to the superior vena cava, into right atrium 122, and into left atrium 120 transseptally, typically through the fossa ovalis.

[0200] In some implementations, once the distal portion of catheter 20 is disposed within atrium 120, the distal steerable portion 26 of catheter 20 is steered in a first plane that is parallel to a plane of the annulus of mitral valve 102. Such steering moves distal steerable portion 26 of catheter 20 in a direction from the interatrial septum toward surrounding walls of the atrium. Steering of distal steerable portion 26 of catheter 20 is performed via steering knob 28 of extracorporeal handle 22.

[0201] In some implementations, following steering of steerable portion 26 of catheter 20, steerable portion 46 and distal portion 48 of catheter 40 are advanced out of the distal end of catheter 20, with distal portion 48 of catheter 40 being in a contracted state. As such, and as seen in Fig. 2A, steerable portion 46 and distal portion 48 of catheter 40 extend beyond the distal end of catheter 20. Exposed steerable portion 46 of catheter 40 is then steered toward the annulus of valve 102 along a plane that is perpendicular with respect to the steering plane of catheter 20 and that is perpendicular with respect to valve 102. In some implementations, the steering can include bending of steerable portion 46 toward valve 102.

[0202] In some implementations, steering of the steerable portion 46 of catheter 40 is performed via steering-control 56 of handle 42 (in Fig. 1). Following steering of steerable portion 46, distal opening 50 of catheter 40 faces in the operative direction, toward valve 102.

[0203] In some implementations, for example as illustrated in Fig. 2 A, anchor driver 110 picks up a first anchor 104 of annul oplasty structure 100 from a first accommodatingchamber 49 in catheter 40 (see Fig. 1 A), and advances the first anchor through flexible tube 44 of catheter 40, toward valve 102.

[0204] As shown in Fig. 2B, following steering of steerable portion 46 so that distal opening 50 faces in the operative direction, distal portion 48 is extended until distal opening 50 is adjacent, or in engagement with, annulus 130 surrounding valve 102. Extension of distal portion 48 occurs without further steering of steerable portion 46 and without steering of distal portion 48.

[0205] In some implementations, extension of distal portion 48 of catheter 40 is performed via extension-control 58 of handle 42 (in Fig. 1), as explained in further detail hereinbelow with respect to Figs. 4A to 4E.

[0206] In some implementations, extension of distal portion 48 of catheter 40 is performed by release of a contraction retaining element, for example by engaging extension-control 58 of handle 42 (in Fig. 1), as explained in hereinbelow with respect to Figs. 3 A to 3E.

[0207] In some implementations, extension of distal portion 48 may be driven by passage of a delivery tool, such as anchor driver 110, therethrough, as explained in further detail hereinbelow with respect to Figs. 5A to 5E.

[0208] In some implementations, while distal opening 50 of second catheter 40 engages annulus 130, anchor driver 110 drives the first tissue anchor 104 of annuloplasty structure 100 into annulus 130, as seen clearly in Fig. 2C. Subsequently, anchor driver 110 retracts in a proximal direction, and distal portion 48 of second catheter 40 contracts toward steerable portion 46, such that distal opening 50 is distanced from annulus 130, leaving first tissue anchor 104 in the annulus and tether 106 extending through second catheter 40. Contraction of distal portion 48 occurs without further steering of steerable portion 46 and without steering of distal portion 48.

[0209] In some implementations, contraction of distal portion 48 of catheter 40 is performed via extension-control 58 of handle 42 (in Fig. 1), as explained in further detail hereinbelow with respect to Figs. 3 A to 3E.

[0210] In some implementations, contraction of distal portion 48 of catheter 40 is performed by release of an extension retaining element, for example by engaging extension-control 58 of handle 42 (in Fig. 1), as explained in further detail hereinbelow with respect to Figs. 4A to 4E.

[0211] In some implementations, contraction of distal portion 48 may be driven by retraction of anchor driver 110 in a proximal direction, as explained in further detail hereinbelow with respect to Figs. 5A to 5E.

[0212] As shown in Fig. 2D, following contraction of distal portion 48 toward steerable portion 46, distal opening 50 of second catheter 40 is steered to point in another operative direction, toward a tissue site suitable for driving of the next tissue anchor of annuloplasty structure 100. Steering of distal opening 50 includes steering of distal portion 46 of second catheter 40 as shown in Fig. 2D (e.g., by use of steering-control 56 of handle 42). In some implementations, steering of distal opening 50 may further include additional steering of steerable portion 26 of first catheter 20.

[0213] Following steering of distal opening 50 toward the next tissue site, extension of distal portion 48 of catheter 40, and driving of a second tissue anchor 104b of annuloplasty structure 100 are repeated, substantially as described hereinabove with respect to Fig. 2B. It is to be appreciated that between the state shown in Fig. 2C and the state shown in Fig. 2D, anchor driver 110 has been retracted proximally to handle 42 of catheter 40, to pick up second tissue anchor 104b from an accommodating chamber 49 in which it was held, and was then advanced through catheter 40, e.g., substantially as described above with respect to Fig. 2B, to reach the position shown in Fig. 2D.

[0214] Subsequently, and as shown in Fig. 2E, distal portion 48 of catheter 40 is contracted in a distal direction, substantially as described hereinabove with respect to Fig. 2C, leaving tissue anchors 104 and 104b implanted in annulus 130, with tether 106 extending therebetween, and into second catheter 40.

[0215] It is to be appreciated that the steps described herein with respect to Figs. 2D and 2E can be repeated, as necessary, until all the tissue anchors of annuloplasty structure 100 are implanted in annulus 130. Subsequently, tether 106 may be tightened, for example as described in International Patent Application Publication WO 2024 / 121770 to Halabi et al, which is incorporated by reference as if fully set forth herein.

[0216] Reference is now made to Figs. 3A-3E, which are schematic illustrations of an extension mechanism of a second catheter 40 forming part of system 10 of Fig. 1, in accordance with some implementations. Figs. 3 A-3E are shown with respect to driving of a tissue anchor 140 into tissue 142, via a tissue surface 144. Tissue anchor 140 is driven by anchor driver 148.

[0217] As seen in Fig. 3 A-3E, distal portion 48 of second catheter 40 has embedded therein a compression spring 150. A tether 152, which extends through distal portion 48 has a distal end 152a in engagement with a distal end 150a of compression spring 150, and extends proximally to handle 42, where a proximal end of tether 152 (not explicitly shown) can be manipulated by an operator, for example by manipulation of extension-control 58 of handle 42.

[0218] Distal portion 48 is retained in the contracted position, illustrated in Fig. 3A, by pulling, or tensioning, of tether 152, which compresses spring 150. In this arrangement, distal opening 50 of second catheter 40 is distanced from tissue surface 144.

[0219] Distal portion 48 is extended toward tissue surface 144, in the direction of arrow 154, by relieving tension from tether 152, which allows spring 150 to return to its elongated rest position. This elongation of spring 150 causes corresponding elongation of the material of distal portion 48 in which the spring is embedded, resulting in engagement of distal opening 50 of catheter 40 with tissue surface 144, as shown in Fig. 3B.

[0220] The change in the length of distal portion 48 is confined to a portion of the catheter between a proximal end 150b of spring 150 and distal end 150a thereof.

[0221] In Fig. 3A, the contracted length of distal portion 48 is indicated by Lc, and in Fig.3B, the extended length of distal portion 48 is indicated by Le.

[0222] In some implementations, the lengths Lc and Le are measured from the proximal end of distal portion 48.

[0223] In some implementations, the proximal end of distal portion 48 is at, or immediately distal to, a steering ring, attached to pull wires, of steering portion 46 of catheter 40. In some implementations, the proximal end of distal portion 48 is at a longitudinal location of proximal end 150b of spring 150, or a proximal end 180b of spring 180 (Figs. 4A-4E). In some implementations, the proximal end of distal portion 48 is at a longitudinal proximal end of a feed tube 183 feeding into a hydraulic mechanism 182 (Figs. 4A-4B).

[0224] In some implementations, the lengths Lc and Le are measured from the proximal end of distal portion 48 to distal opening 50.

[0225] In some other implementations, e.g., as shown in Figs. 3A-3B, the lengths Lc and Le are measured from the proximal end of distal portion 48 to a distal end of the distal portion.

[0226] In some implementations, the distal end of distal portion 48 is at a distal end of tether 152. In some implementations, the distal end of distal portion 48 is at a longitudinal location of distal end 150a of spring 150, or a distal end 180a of spring 180 (Figs. 4A-4E). In some implementations, the distal end of distal portion 48 is at a distal end of hydraulic mechanism 182 (Figs. 4A-4E). In some implementations, the distal end of distal portion 48 is at, immediately proximal to, the proximal walls of protrusions 200 (Figs. 5A-5E).

[0227] In some implementations, a ratio between length Le and length Lc may be in the range of 2:1, 3:1, or 4:1.

[0228] In some implementations, when distal opening 50 of catheter 40 is in engagement with tissue surface 144, or during extension of distal portion 48 toward the tissue surface, anchor driver 148, associated with tissue anchor 140, is advanced through the lumen of catheter 40 toward tissue 142, as indicated by arrow 156. In Fig. 3C, anchor driver 148 is advanced distally to the point that tissue anchor 140 engages tissue surface 144. Anchor driver 148 then drives a tissue-engaging portion of tissue anchor 140 into tissue 142 via tissue surface 144, for example by rotation of the anchor driver, as indicated by arrow 158. During driving of anchor 140, there is no change in the position of catheter 40, or in the length of distal portion 48 thereof.

[0229] Following driving in of tissue anchor 140, anchor driver 148 is retracted in a proximal direction, as indicated by arrow 160 in Fig. 3D. In some implementations, and as illustrated, during retraction of anchor driver 148, distal opening 50 of catheter 40 can remain in engagement with tissue surface 144.

[0230] Following removal of anchor driver 148 from distal portion 48 of catheter 40, the distal portion is contracted, for example by an operator manipulating a proximal end of tether 152. Such manipulation of tether 152 causes pulling of the tether in a proximal direction, as shown by arrow 162 in Fig. 3E. Pulling of the tether applies force to distal end 150a of spring 150, pulling the distal end of the spring toward its proximal end 150b, thereby contracting the spring and distal portion 48 of the catheter, in the direction of arrow 162. In some implementations, contraction of spring 150 causes distal portion 48 to re-assume its contracted length Lc, as shown in Fig. 3E.

[0231] As shown in Figs. 3 A-3E, throughout the entire process of driving in tissue anchor 140, a distance d between distal end 150a of compression spring 150 and distal opening 50of catheter 40 remains fixed, regardless of the extension of distal portion 48 of the catheter. Additionally, no steering is applied to distal portion 48.

[0232] Reference is now made to Figs. 4A-4E, which are schematic illustrations of an extension mechanism of a second catheter 40 forming part of system 10 of Fig. 1, in accordance with some implementations. Figs. 4A-4E are shown with respect to driving of tissue anchor 140 into tissue 142, via a tissue surface 144. Tissue anchor 140 is driven by anchor driver 148.

[0233] As seen in Fig. 4A-4E, distal portion 48 of second catheter 40 has embedded therein an extension spring 180. A hydraulic mechanism 182, which extends through distal portion 48 has a distal end 182a in engagement with a distal end 180a of extension spring 180. Hydraulic mechanism 182 is functionally associated with a feed tube 183 and with extension-control 58 of handle 42, such that manipulation of the extension-control causes feeding of a fluid, via feed tube 183 into hydraulic mechanism 182, resulting in elongation of the hydraulic mechanism and corresponding extension of spring 180.

[0234] In some implementations, distal portion 48 is at rest in the contracted position, illustrated in Fig. 4A, in which extension spring 180 is at rest. In this arrangement, distal opening 50 of second catheter 40 is distanced from tissue surface 144.

[0235] In some implementations, distal portion 48 is extended toward tissue surface 144, in the direction of arrow 184, by operation of hydraulic mechanism 182, which causes extension of spring 180 toward tissue surface 144. This extension of spring 180 causes corresponding elongation of the material of distal portion 48 in which the spring is embedded, resulting in engagement of distal opening 50 of catheter 40 with tissue surface 144, as shown in Fig. 4B.

[0236] In a similar manner to that described hereinabove with respect to Figs. 3A-3B, the change in the length of distal portion 48 is confined to a portion of the catheter between a proximal end 180b of spring 180 and distal end 180a thereof.

[0237] In some implementations, when distal opening 50 of catheter 40 is in engagement with tissue surface 144, or during extension of distal portion 48 toward the tissue surface, anchor driver 148, associated with tissue anchor 140, is advanced through the lumen of catheter 40 toward tissue 142, as indicated by arrow 186. In Fig. 4C, anchor driver 148 is advanced distally to the point that tissue anchor 140 engages tissue surface 144. Anchor driver 148 then drives a tissue-engaging portion of tissue anchor 140 into tissue 142 viatissue surface 144, for example by rotation of the anchor driver, as indicated by arrow 188. During driving of anchor 140, there is no change in the position of catheter 40, or in the length of distal portion 48 thereof.

[0238] In some implementations, following driving in of tissue anchor 140, anchor driver 148 is retracted in a proximal direction, as indicated by arrow 190 in Fig. 4D. In some implementations, and as illustrated, during retraction of anchor driver 148, distal opening 50 of catheter 40 can remain in engagement with tissue surface 144.

[0239] In some implementations, following removal of anchor driver 148 from distal portion 48 of catheter 40, the distal portion is contracted, for example by releasing of the force applied by hydraulic mechanism 182 on spring 180, which allows the spring to compress back to its rest state. Such compression of spring 180 results in contraction of distal portion 48 of the catheter, in the direction of arrow 192. In some implementations, compression of spring 180 causes distal portion 48 to re-assume its contracted length, as shown in Fig. 4E.

[0240] As shown in Figs. 4A-4E, throughout the entire process of driving in tissue anchor 140, a distance d between distal end 180a of extension spring 180 and distal opening 50 of catheter 40 remains fixed, regardless of the extension of distal portion 48 of the catheter. Additionally, no steering is applied to distal portion 48.

[0241] In some implementations, extension of extension spring 180, and corresponding extension of distal portion 48 of catheter 40, may be accomplished by a mechanism other than hydraulic mechanism 182 described herein. For example, in some implementations, a pneumatic mechanism may be used instead of the hydraulic mechanism, to apply force to extension spring 180 for extension thereof. As another example, in some implementations, a push rod may be functionally associated with the distal end of extension spring 180, and may be manipulated to apply force to the extension spring for extension thereof.

[0242] Reference is now made to Figs. 5A-5E, which are schematic illustrations of an extension mechanism of a second catheter 40 forming part of system 10 of Fig. 1, in accordance with some implementations. Figs. 5A-5E are shown with respect to driving of tissue anchor 140 into tissue 142, via tissue surface 144. Tissue anchor 140 is driven by anchor driver 148.

[0243] As seen in Fig. 5A-5E, distal portion 48 of second catheter 40 is formed of an elastic and resilient material, which can be stretched when a force is applied thereto in a longitudinal direction, and can return to its original dimensions when the force is released. A plurality ofprotrusions 200 extend radially inwardly into catheter 40, between distal portion 48 and distal opening 50, causing an internal diameter of catheter 40 to be narrowed between the distal portion and the distal opening.

[0244] In the initial state, of Fig. 5A, distal portion 48 is at rest, and the elastic material thereof is not stretched. In this arrangement, distal opening 50 of second catheter 40 is distanced from tissue surface 144.

[0245] In Fig. 5B, tissue anchor 140, together with anchor driver 148, are advanced distally through the lumen of second catheter 40, in the direction of arrow 204. When tissueengaging portion 202 of tissue anchor 140 engages a proximal wall of protrusions 200 of catheter 40, continued advancement of anchor driver 148 and the tissue anchor causes stretching of distal portion 48 of the catheter in a distal direction, so that distal portion 48 extends toward tissue surface 144, in the direction of arrow 206. As a result, distal opening 50 of catheter 40 engages tissue surface 144, as shown in Fig. 5B.

[0246] In a similar manner to that described hereinabove with respect to Figs. 3A-3B, the change in the length of distal portion 48 is confined to non-steerable distal portion 48 of the catheter, which is formed of an elastic material.

[0247] As seen in Fig. 5C, when distal opening 50 of catheter 40 is in engagement with tissue surface 144, or during extension of distal portion 48 toward the tissue surface, anchor driver 148 drives tissue-engaging portion 202 of tissue anchor 140 into tissue 142 via tissue surface 144, for example by continued distal advancement and rotation of the anchor driver, as indicated by arrows 208 and 210.

[0248] In some implementations, during driving of anchor 140, anchor driver 148 continues to apply force to the proximal walls of protrusions 200, thereby ensuring that the elastic material of distal portion 48 remains stretched, and that there is no change in the position of catheter 40, or in the length of distal portion 48 thereof. In some implementations, for tissueengaging portion 202 to be driven into the tissue, it is aligned to pass between protrusions 200, as shown in Fig. 5C.

[0249] In some implementations, following driving in of tissue anchor 140, anchor driver 148 is retracted in a proximal direction, as indicated by arrow 212 in Fig. 5D. This retraction of anchor driver 148 removes the force that was applied to the proximal walls of protrusions 200, thereby allowing the elastic material of distal portion 48 to return to its rest state, resulting in contraction of distal portion 48 in the direction of arrow 214. When anchor driver148 is fully removed from distal portion 48 of catheter 40, distal portion 48 re-assumes its contracted length, as shown in Fig. 5E.

[0250] It is to be appreciated that, in some implementations of the mechanism of Figs. 5A-5E, extension-control 58 of second catheter 40 can be obviated, since extension of distal portion 48 is the result of extension of the elastic material of the distal portion, during application of force thereto.

[0251] Although catheter 40 is described in the context of annuloplasty, it is to be understood that its features (e.g. length-changing of its distal portion) may be incorporated into other catheter-based systems, such as those for other treatments including, but not limited to, heart valve leaflet repair, prosthetic valve implantation, pacemaker implantation, and myocardium ablation. For example, any of the systems described in the following publications, each of which is incorporated herein by reference, may be modified to incorporate features of catheter 40:International Patent Application publication WO 2013 / 069019 to Sheps et al.International Patent Application publication WO 2014 / 064694 to Sheps et al.International Patent Application publication WO 2016 / 174669 to Iflah et al.International Patent Application publication WO 2024 / 121770 to Halabi et al.

[0252] The various systems, devices, apparatuses, etc. in this disclosure can be sterilized (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure they are safe for use with patients, and the methods herein can comprise such sterilization of the associated system, device, apparatus, etc. Furthermore, the scope of the present disclosure includes, for some applications, sterilizing one or more of any of the various systems, devices, apparatuses, etc. in this disclosure.

[0253] 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. Further, the techniques, methods, operations, steps, etc. described or suggested herein can be performed on a living animal or on a non-living simulation, such as on a cadaver, cadaver heart, simulator (e.g. with the body parts, tissue, etc. being simulated), etc.

[0254] Although the operations of some of the disclosed implementations 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 above. For example, operations or steps described sequentially can in some cases be rearranged or performed concurrently. Moreover, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed methods can be used in conjunction with other methods. Additionally, the description sometimes uses terms like “provide” or “achieve” to describe the disclosed methods. These terms are high-level abstractions of the actual operations that are performed. The actual operations that correspond to these terms can vary depending on the particular implementation and are discernible by one of ordinary skill in the art.

Claims

CLAIMS1. A system for use with a subject, the system comprising:(a) a first catheter:having a proximal end, and a distal end that is configured to be transluminally advanced toward an anatomical site of the subject, anddefining a first lumen between the proximal end and the distal end;(b) a second catheter:having a handle, a proximal portion extending distally from the handle, a steerable portion continuing distally from the proximal portion, and a distal portion continuing distally from the steerable portion to point in an operative direction, defining a continuous lumen through the proximal, steerable, and distal portions, the continuous lumen terminating at a distal opening at the distal portion of the second catheter, the distal opening facing in the operative direction, and configured to be advanced toward the anatomical site via the first lumen such that the steerable portion becomes exposed distally out of the first lumen, wherein:the handle comprises a steering-control and an extension-control, at least in part via operative coupling between the steerable portion and the steering-control, the steerable portion is configured to, responsively to operation of the steering-control, deflect the distal portion to change the operative direction, and at least in part via operative coupling between the distal portion and the extension-control, the distal portion is configured to, responsively to operation of the extension-control, alter its length as measured between the steerable portion and the distal opening;(c) an implant; and(d) a delivery tool, adapted to extend through the continuous lumen, to advance the implant out of the distal opening, and to secure the implant to tissue at the anatomical site.

2. The system according to claim 1, wherein the first catheter has:a distal steerable region; anda first handle, the proximal end of the first catheter being coupled to the first handle, the first handle including a steering knob such that at least in part via operative coupling between the distal steerable portion of the first catheter and the steering knob, the distalsteerable portion of the first catheter is configured to be deflected responsively to operation of the steering knob.

3. The system according to claim 2, wherein the distal steerable portion of the first catheter is steerable in a first plane, perpendicular to a longitudinal axis of the distal portion of the second catheter, and the steerable portion of the second catheter is steerable in a second plane, perpendicular to the first plane and perpendicular to the longitudinal axis of the distal portion of the second catheter.

4. The system according to any one of claims 2-3, wherein advancement of the second catheter through the first lumen brings the handle of the second catheter into proximity of the first handle of the first catheter.

5. The system according to claim 4, wherein, advancement of the second catheter through the first lumen causes coupling of the handle of the second catheter to the first handle of the first catheter, thereby to form a proximal handle portion.

6. The system according to any one of claims 4-5, wherein the handle of the second catheter and the first handle of the first catheter have a locked state, inhibiting rotation of the proximal portion of the second catheter within the first lumen.

7. The system according to any one of claims 1-6, wherein the second catheter is slidable through the first catheter.

8. The system according to any one of claims 1-7, wherein the distal portion of the second catheter has a contracted state in which the distal portion has a first length and an extended state in which the distal portion has a second length, longer than the first length, the first and second lengths being measured between a distal end of the steerable portion of the second catheter and the distal opening of the second catheter.

9. The system according to claim 8, wherein an external diameter of the distal portion is substantially fixed in the contracted state.

10. The system according to claim 8, wherein an external diameter of the distal portion is substantially fixed in the extended state.

11. The system according to claim 8, wherein an external diameter of the distal portion is substantially equal in the contracted and extended states.

12. The system according to any one of claims 8-11, wherein the distal portion of the second catheter is at rest in the contracted state, and is extended to the extended state responsively to user manipulation of the extension-control.

13. The system according to claim 12, wherein the second catheter further comprises:an extension spring extending through the distal portion, the extension spring adapted to have a contracted rest state; anda spring extension mechanism, functionally associated with the extension-control, such that user manipulation of the extension-control causes the spring extension mechanism to apply force to the extension spring to cause extension thereof, thereby causing extension of the distal portion to assume the second length.

14. A catheter configured to be transluminally advanced toward an anatomical site of a subject, the catheter comprising:a handle comprising a steering-control and an extension-control;a proximal portion extending distally from the handle;a steerable portion continuing distally from the proximal portion;a distal portion continuing distally from the steerable portion to point in an operative direction; anda continuous lumen defined through the proximal, steerable, and distal portions, the continuous lumen terminating at a distal opening at the distal portion of the catheter, the distal opening facing in the operative direction,wherein:at least in part via operative coupling between the steerable portion and the steering-control, the steerable portion is configured to, responsively to operation of the steering-control, deflect the distal portion to change the operative direction, and at least in part via operative coupling between the distal portion and the extension-control, the distal portion is configured to, responsively to operation of the extension-control, alter its length as measured between the steerable portion and the distal opening.

15. The catheter according to claim 14, wherein the proximal, steerable, and distal portions are adapted to be slidable through a delivery catheter toward the anatomical site.

16. The catheter according to any one of claims 14-15, wherein the distal portion has a contracted state in which the distal portion has a first length and an extended state in whichthe distal portion has a second length, longer than the first length, the first and second lengths being measured between the steerable portion and the distal opening.

17. The catheter according to claim 16, wherein an external diameter of the distal portion is substantially fixed in the contracted state.

18. The catheter according to any one of claims 16-17, wherein an external diameter of the distal portion is substantially fixed in the extended state.

19. The catheter according to any one of claims 16-17, wherein an external diameter of the distal portion is substantially equal in the contracted and extended states.

20. The catheter according to any one of claims 16-19, wherein the distal portion is at rest in the contracted state, and is extended to the extended state responsively to user manipulation of the extension-control.

21. The catheter according to claim 20, further comprising:an extension spring extending through the distal portion, the extension spring adapted to have a contracted rest state; anda spring extension mechanism, functionally associated with the extension-control, such that user manipulation of the extension-control causes the spring extension mechanism to apply force to the extension spring to cause extension thereof, thereby causing extension of the distal portion to assume the second length.

22. The catheter according to claim 21, wherein the spring extension mechanism comprises a pneumatic mechanism, functionally associated with a distal end of the extension spring and with the extension-control, wherein:user manipulation of the extension-control in a first manner causes pneumatic extension of the pneumatic mechanism, resulting in application of force, in a distal direction, to the distal end of the extension spring, resulting in extension of the extension spring and in the distal portion assuming the second length; anduser manipulation of the extension-control in a second manner causes contraction of the pneumatic mechanism, releasing the force from the distal end of the extension spring, and allowing the extension spring to return to the contracted rest state, resulting in the distal portion reassuming the first length.

23. The catheter according to claim 21, wherein the spring extension mechanism comprises a hydraulic mechanism, functionally associated with a distal end of the extension spring and with the extension-control, wherein:user manipulation of the extension-control in a first manner causes hydraulic extension of the hydraulic mechanism, resulting in application of force, in a distal direction, to the distal end of the extension spring, resulting in extension of the extension spring and in the distal portion assuming the second length; anduser manipulation of the extension-control in a second manner causes contraction of the hydraulic mechanism, releasing the force from the distal end of the extension spring, and allowing the extension spring to return to the contracted rest state, resulting in the distal portion reassuming the first length.

24. The catheter according to claim 21, wherein the spring extension mechanism comprises a pushing rod extending through the catheter, the pushing rod being functionally associated with a distal end of the extension spring and with the extension-control, wherein:user manipulation of the extension-control in a first manner causes distal motion of the pushing rod resulting in application of force, in a distal direction, to the distal end of the extension spring, resulting in extension of the extension spring and in the distal portion assuming the second length; anduser manipulation of the extension-control in a second manner causes proximal motion of the extension rod, releasing the force from the distal end of the extension spring, and allowing the extension spring to return to the contracted rest state, resulting in the distal portion reassuming the first length.

25. The catheter according to any one of claims 16-19, wherein the distal portion is at rest in the extended state, and is contracted to the contracted state responsively to user manipulation of the extension-control.

26. The catheter according to claim 25, further comprising:a compression spring extending through the distal portion, the compression spring adapted to have an extended rest state; anda spring compression mechanism, functionally associated with the extension-control, such that user manipulation of the extension-control causes the spring compression mechanism to apply force to the compression spring, in a proximal direction, to cause compression thereof, thereby causing compression of the distal portion from the second length to assume the first length.

27. The catheter according to claim 26, wherein the spring compression mechanism comprises a tether extending through the catheter, the tether being functionally associated with a distal end of the compression spring and with the extension-control, wherein:user manipulation of the extension-control in a first manner causes pulling of the tether in a proximal direction, resulting in application of force, in a proximal direction, to the distal end of the compression spring, resulting in compression of the compression spring and in the distal portion assuming the first length; anduser manipulation of the extension-control in a second manner causes release of the tether, releasing the force from the distal end of the compression spring, and allowing the compression spring to return to the extended rest state, resulting in the distal portion reassuming the second length.

28. The catheter according to any one of claims 14-27, wherein the distal portion is devoid of steering ability.

29. The catheter according to any one of claims 14-28, wherein external diameters of the steerable portion and of the distal portion are substantially equal.

30. The catheter according to any one of claims 14-29, wherein the catheter is adapted for delivery of a plurality of tissue anchors to the anatomical site, and wherein the handle comprises a plurality of chambers adapted to accommodate the plurality of tissue anchors.

31. A system for use with a subject, the system comprising:(a) a first catheter:having a proximal end, and a distal end that is configured to be transluminally advanced toward an anatomical site of the subject, anddefining a first lumen between the proximal end and the distal end;(b) a second catheter:having a handle, a proximal portion extending distally from the handle, a steerable portion continuing distally from the proximal portion, and a distal portion continuing distally from the steerable portion to point in an operative direction, defining a continuous lumen through the proximal, steerable, and distal portions, the lumen terminating at a distal opening at the distal portion of the second catheter, the distal opening facing in the operative direction, andconfigured to be advanced toward the anatomical site via the first lumen such that the steerable portion becomes exposed distally out of the first lumen,wherein:the handle comprises a steering-control,at least in part via operative coupling between the steerable portion and the steering-control, the steerable portion is configured to, responsively to operation of the steering-control, deflect the distal portion to change the operative direction, and said distal portion is elastic and includes at least one inwardly-extending protrusion;(c) an implant; and(d) a delivery tool, adapted to extend through the continuous lumen, to advance the implant out of the distal opening, and to secure the implant to tissue at the anatomical site, wherein during advancement of the delivery tool and the implant in a distal direction, the implant or the delivery tool is adapted to apply force to the at least one inwardly -facing protrusion, thereby to extend a length of the distal portion of the second catheter as measured between a distal end of the steerable portion of the second catheter and the distal opening of the second catheter, from a first length to a second length.

32. The system according to claim 31, wherein the first catheter has:a distal steerable portion; anda first handle, the proximal end of the first catheter being coupled to the first handle, the first handle including a steering knob such that at least in part via operative coupling between the distal steerable portion of the first catheter and the steering knob, the distal steerable portion of the first catheter is configured to be deflected responsively to operation of the steering knob.

33. The system according to claim 32, wherein the distal steerable portion of the first catheter is steerable in a first plane, perpendicular to a longitudinal axis of the distal portion of the second catheter, and the steerable portion of the second catheter is steerable in a second plane, perpendicular to the first plane and perpendicular to the longitudinal axis of the distal portion of the second catheter.

34. The system according to any one of claims 32-33, wherein advancement of the second catheter through the first lumen brings the handle of the second catheter into proximity of the first handle of the first catheter.

35. The system according to claim 34, wherein, advancement of the second catheter through the first lumen causes coupling of the handle of the second catheter to the first handle of the first catheter, thereby to form a proximal handle portion.

36. The system according to any one of claims 34-35, wherein the handle of the second catheter and the first handle of the first catheter have a locked state, inhibiting rotation of the proximal portion of the second catheter within the first lumen.

37. The system according to any one of claims 31-36, wherein the second catheter is slidable through the first catheter.

38. The system according to any one of claims 31-37, wherein the distal portion of the second catheter has a contracted rest state in which the distal portion has the first length and an extended state in which the distal portion has the second length.

39. The system according to claim 38, wherein an external diameter of the distal portion is substantially fixed in the contracted state.

40. The system according to any one of claims 38-39, wherein an external diameter of the distal portion is substantially fixed in the extended state.

41. The system according to any one of claims 31-40, wherein an external diameter of the distal portion is substantially equal in the contracted and extended states.

42. The system according to any one of claims 31-41, wherein the distal portion of the second catheter is devoid of steering ability.

43. The system according to any one of claims 31-42, wherein external diameters of the steerable portion and of the distal portion of the second catheter are substantially equal.

44. The system according to any one of claims 31-43, wherein the implant comprises a tissue anchor, and the delivery tool comprises an anchor driver.

45. The system according to claim 44, wherein the implant comprises a plurality of tissue anchors adapted to be driven by the anchor driver, and wherein the handle of the second catheter comprises a plurality of chambers adapted to accommodate the plurality of tissue anchors.

46. A catheter configured to be transluminally advanced toward an anatomical site of a subject, for advancement of an implant and a delivery tool toward the anatomical site through the catheter, the catheter comprising:a handle comprising a steering-control;a proximal portion extending distally from the handle;a steerable portion continuing distally from the proximal portion;an elastic distal portion continuing distally from the steerable portion to point in an operative direction, the elastic distal portion including at least one inwardly-extending protrusion; anda continuous lumen defined through the proximal, steerable, and distal portions, the lumen terminating at a distal opening at the distal portion of the second catheter, the distal opening facing in the operative direction,wherein:at least in part via operative coupling between the steerable portion and the steering-control, the steerable portion is configured to, responsively to operation of the steering-control, deflect the distal portion to change the operative direction, and during advancement of the delivery tool and the implant in a distal direction toward the distal opening, the implant or the delivery tool is adapted to apply force to the at least one inwardly-facing protrusion, thereby to extend a length of the distal portion as measured between the steerable portion and the distal opening, from a first length to a second length.

47. The catheter according to claim 46, wherein the proximal, steerable, and distal portions are adapted to be slidable through a delivery catheter toward the anatomical site.

48. The catheter according to any one of claims 46-47, wherein the distal portion has a contracted rest state in which the distal portion has the first length and an extended state in which the distal portion has the second length.

49. The catheter according to claim 48, wherein an external diameter of the distal portion is substantially fixed in the contracted state.

50. The catheter according to any one of claims 46-49, wherein an external diameter of the distal portion is substantially fixed in the extended state.

51. The catheter according to any one of claims 46-50, wherein an external diameter of the distal portion is substantially equal in the contracted and extended states.

52. The catheter according to any one of claims 46-51, wherein the distal portion is devoid of steering ability.

53. The catheter according to any one of claims 46-52, wherein the catheter is adapted for delivery of a plurality of tissue anchors to the anatomical site, and wherein the handle comprises a plurality of chambers adapted to accommodate the plurality of tissue anchors.

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