Edwards Lifesciences Innovation (Israel) Ltd.

A system includes a transcatheterally-advanceable driver and an implant. The implant includes a winch, and a tether that has an end portion. The winch includes a spool, a mount, and a driver interface engageable and drivable by the driver. The mount is coupled to the driver interface such that driving of the driver interface by the driver rotates the mount about a rotation axis. The spool is coupled to the tether, and defines a spool axis that is non-coaxial with the rotation axis. The tether extends away from the winch toward the end portion. The spool is fixedly coupled to the mount such that rotation of the mount about the rotation axis draws the end portion of the tether toward the spool by winding the tether around the spool axis of the spool. Other embodiments are also described.

A method is described, for use with a native valve of a heart of a subject, the valve being disposed between an atrium and a ventricle of the heart. A first radiopaque marker and a second radiopaque marker are percutaneously advanced to the heart. The first radiopaque marker is placed against a tissue site in the ventricle. The second radiopaque marker is placed against a component of the valve. A distance is fluoroscopically measured between the first radiopaque marker at the tissue site, and the second radiopaque marker at the component. At least one of the radiopaque markers is then withdrawn from the heart. Other embodiments are also described.

A steerable catheter comprises a flexible tube comprising a circumferential wall, along which a pull-wire extends, and that defines an elongate lumen from the tube's proximal portion to the tube's distal portion. A pull-ring, circumscribing the lumen at the distal portion, is coupled to the pull-wire and the wall such that pulling on the pull-wire bends the distal portion. The pull ring can be: (i) biased toward a first state in which the pull-ring is elliptical, and (ii) deformable to a second state in which the pull-ring has a lesser eccentricity. The tube can have a delivery state in which the pull-ring is in the first state and the distal portion's outer surface has a first surface eccentricity, and a working state in which the pull-ring is in the second state and the outer surface has a second, greater surface eccentricity. Other embodiments are also described.

Using a delivery tool, an annuloplasty structure is secured on an annulus of a valve of a subject, the annuloplasty structure including (i) a flexible sleeve that defines a longitudinal lumen therethrough, and (ii) an elongate contraction member attached to the flexible sleeve. Subsequently, while the delivery tool is coupled to the annuloplasty structure, the sleeve is longitudinally contracted by drawing the contraction member into the lumen. Other embodiments are also described.

An annuloplasty implant is implanted along a valve annulus of a heart of a subject using a driver that includes a flexible shaft and a deployment element at a distal end of the shaft by, for each of the anchors in turn, beginning with the distal anchor: (1) using the driver to move the anchor out of a corresponding anchor-storage area of a tool; (2) advancing the anchor distally through a tube of the tool, with the shaft of the driver extending past the anchor-storage area; (3) anchoring the anchor to tissue of the heart; (4) disengaging the driver from the anchor; and (5) retracting the driver proximally beyond the corresponding anchor-storage area and, at a successively-proximal anchor-storage area, engaging the anchor with the successive anchor. Other embodiments are also described.

Using a driver, a tissue anchor is advanced to a tissue of a subject. The tissue anchor includes an anchoring portion, an anchor head fixedly coupled to the anchoring portion, and a driver interface. The anchoring portion is screwed distally into the tissue by, while the driver is engaged with the driver interface, applying torque, via the driver, to the driver interface such that the anchor head and the anchoring portion rotate together about a longitudinal axis of the tissue anchor. Continued screwing of the anchoring portion distally into the tissue is performed by continuing to apply the torque at least until the driver interface becomes rotatable relative to the anchor head. Subsequently, the driver is disengaged from the driver interface and removed from the subject, while leaving the tissue anchor anchored to the tissue. Other embodiments are also described.

A system includes an annulus-marking device that comprises a two or more pull wires coupled to an expandable braided mesh. Pulling the pull wires can transition the braided mesh into a shape in which the mesh assumes (1) a sloped upper portion configured for positioning within an atrium of a heart of the subject, (2) a bulging ledge portion configured for positioning above the heart valve, and (3) a narrow portion for positioning within the heart valve. The system can also include an implant configured for placement along a native heart valve annulus of a subject. The implant can include a body portion comprising flexible material, the body portion having a longitudinal axis that runs along a length of the body portion. Other embodiments are also described.

A steerable catheter comprises a flexible tube having a proximal portion and a distal portion and comprising a circumferential wall that defines an elongate lumen between the proximal portion and the distal portion. A pull-wire can extend, in association with the wall, from the proximal portion to the distal portion. A pull-ring can be coupled to the wall at the distal portion such that the pull-ring circumscribes the lumen, and coupled to the pull-wire, such that pulling on the pull-wire bends the distal portion. The pull ring can have (i) a first state in which the pull-ring is elliptical and has a first eccentricity, and (ii) a second state in which the pull-ring is elliptical and has a second eccentricity that is smaller than the first eccentricity. The pull ring can be biased toward the first state, and deformable to the second state. Other embodiments are also described.

A tissue anchor includes a sharp tissue-engaging element and a driving interface which is fixed with respect to the tissue-engaging element. A tube has a blunt cap reversibly attached to and covering a distal end of the tube, and is transluminally advanceable in a distal direction toward an anatomical site within a subject. A driver, while engaged with the driving interface of the tissue anchor, is configured to drive the tissue-engaging element through the blunt cap and into tissue at the anatomical site, such that the blunt cap becomes an anchor-head of the tissue anchor, secured to the tissue by the tissue-engaging element. Other embodiments are also described.

Apparatus, usable with a valve disposed between an atrium and a ventricle of a heart, the valve having a first leaflet (S) and at least one opposing leaflet (A,P). The apparatus comprises an augmenter ( 700 ) that comprises a flexible pouch ( 710 ) and an anchor ( 780 ). The pouch has an external surface, an interior, an outside, and a downstream opening that provides fluid communication between the interior and the outside of the pouch. The anchor is coupled to the pouch, and configured to anchor the pouch to the lip of the first leaflet by the anchor being anchored to the first leaflet. The anchoring is such that the downstream opening opens into the ventricle. Responsively to ventricular systole, the pouch inflates via the downstream opening, and the external surface coapts against the opposing leaflet(s).