Edwards Lifesciences Innovation (israel) Ltd.

Edwards Lifesciences Innovation Ltd.

Ehud Aviv

Tal Reich

Tal Sheps

Amir Gross

Tal Hammer

Yaron Herman

Alexei Koifman

Yuval Zipory

Haim Brauon

Oz Cabiri

Boaz Manash

Kevin K Dang

Meir Kutzik

Brian Patrick Murphy

Omar Fawzi Azanki

Praveen De Silva

Slava Starobinsky

Tai Reich

Or Cohen

Ilia Hariton

Eran Hoffer

Sam Shafigh

Luis Molina

Aaron Anan Ness

Tomer Golan

Sarit Avivi

Amit Peer

Eyal Shaolian

Philip Jiun-An Chen

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.

Multiple anchor delivery tool

An apparatus is provided, for use with a tissue anchor, the apparatus comprising an implant and an anchor-delivery tool. The implant is dimensioned to be advanced into a body of a subject. The tool comprises an anchor-delivery channel and an implant-gripping element. The anchor-delivery channel defines a lumen, and is dimensioned to be moveable within the implant. The implant-gripping element is disposed at a distal end portion of the anchor-delivery channel, and comprises multiple teeth configured to reversibly grip an inner wall of the implant during implantation of the tissue anchor via the anchor-delivery channel. Other embodiments are also described.

Anchor channel tip

System for use with tissue of a heart comprises a tissue anchor comprising an engaging head that has a coupling eyelet that defines an eyelet plane, and a helical tissue-coupling element, reversibly anchorable to the tissue, and having a central helix axis that lies on the eyelet plane. The system also comprises an anchor driver, having a distal portion that has a casing that defines a slot, the slot defining a slot plane, and dimensioned to receive at least part of the eyelet therein in a manner in which the eyelet plane is coplanar with the slot plane. The anchor driver also comprises a detent, configured to reversibly inhibit movement of the eyelet with respect to the slot. The anchor driver is configured to anchor the tissue anchor to the tissue by rotating the tissue anchor by applying a rotational force to the eyelet. Other embodiments are also provided.

Percutaneous tissue anchor techniques

An anchor-handling device comprises a housing shaped to define a channel having an anchor-storage zone and a proximal opening. A tissue anchor is stored in the anchor-storage zone. The anchor-handing device is configured such that, while the tissue anchor is stored in the anchor-storage zone, the tissue anchor is movable out of the anchor-storage zone toward the proximal opening in response to a proximally-directed force being applied to the tissue anchor. The anchor-handling device comprises an element that serves as an indicator of movement of the tissue anchor out of the anchor-storage zone toward the proximal opening by the element moving in response to the proximally-directed force. Other embodiments are also described.

Anchor magazine

A radiopaque frame is transluminally advanced to an atrium of a heart of a subject. The frame is expanded within a valve adjacent the atrium such that part of the frame remains disposed in the atrium. While the frame remains expanded within the valve, progressive portions of an annuloplasty structure are progressively positioned and anchored around the annulus using multiple anchors by, for each of the anchors sequentially (i) while fluoroscopically imaging the frame and a distal end of a delivery tool, and facilitated by mechanical guidance from the frame, positioning the distal end of the delivery tool between the frame and a wall of the atrium; and (ii) driving the anchor into the annulus laterally from the frame. Subsequently, the frame is contracted and withdrawn from the subject while leaving the annuloplasty structure anchored around the annulus. Other embodiments are also described.

Fluoroscopic visualization of heart valve anatomy

A tubular system is configured to transluminally deliver an implant comprising a tissue anchor having a coupling head and a distal helical tissue-engaging element, into a heart of a subject. The tissue anchor is slidable through a channel of the system, the channel being slidable within a catheter. An anchor driver is configured, while coupled to the coupling head of the tissue anchor, to drive the tissue anchor through the system and out the system's distal end, to anchor the tissue-engaging element to tissue of the heart. While a first electrode is in contact with the subject and a second electrode is inside the heart of the subject, a control unit receives an electrophysiological signal from the electrodes, and based on the electrophysiological signal, indicates a position of the second electrode inside the heart. Other embodiments are also described.

Location indication system for implant-delivery tool

An apparatus is provided for use with a tissue anchor and an anchor driver. The apparatus includes a housing, shaped to define a channel. The channel includes (i) an anchor-storage zone, and (ii) a proximal opening configured to provide access for the anchor driver to the anchor-storage zone. The channel is configured to enable sliding of the tissue anchor therewithin to be stored in the anchor-storage zone. The apparatus also includes a retaining member, shaped to define a cradle for cradling and holding the tissue anchor in the anchor-storage zone. The retaining member includes a pillar pivotable with respect to the cradle, and configured to support the tissue anchor at the cradle. Other embodiments are also described.

Tissue anchor handling systems and methods

A method for treating a native heart valve of a patient includes anchoring a plurality of anchors of an implant into tissue around an annulus of the valve. At the annulus, a force-distribution element is incorporated into the implant such that the force-distribution element extends along a longitudinal portion of the elongate contracting member. The method can also include circumferentially tightening the annulus by pulling the plurality of anchors closer together, such as by actuating a contracting mechanism of a contracting system, such that (i) the contracting mechanism, coupled to an elongate contracting member of the implant, applies a longitudinal tensioning force to the elongate contracting member, and (ii) the force-distributing element distributes the longitudinal tensioning force over at least two of the anchors. Other embodiments are also described.

Annuloplasty implants

A method is described for use with a heart of a subject, the heart having a valve and an atrium upstream of the valve. The method includes transluminally advancing multiple tissue anchors to the atrium; and securing an elongate contraction member at least partly around an annulus of the valve by anchoring the tissue anchors to the annulus, such that the tissue anchors are distributed along the elongate contraction member. The method further includes subsequently contracting the annulus by applying tension the elongate contraction member, such that a radiopaque indicator that is disposed within the heart and that is coupled to the contraction member undergoes a conformational change in response to the tension. The conformational change of the radiopaque indicator within the heart is observed, and the tension is adjusted responsively to the observed conformational change. Other embodiments are also described.

Annuloplasty technologies

A catheter, advanced toward an anatomical site, has a proximal end and a steerable distal end. An anchor is advanced through the catheter. An anchor driver drives the anchor out of the catheter's distal end, anchoring the anchor at the site. A first constraining member engages tissue, and inhibits, after the anchor has been driven out of the catheter and before the anchoring, movement of at least the anchor driver's distal end, on a first axis between the anchor driver's distal end and a site at which the first constraining member engages the tissue. A second constraining member inhibits, after the anchor has been driven out of the catheter and before the anchoring, movement of at least the anchor driver's distal end, on a second axis. Other embodiments are also described.

A first catheter has a first lumen therealong, a first-catheter proximal portion, and a steerable first-catheter distal portion that is transluminally advanceable to the heart. A second catheter has second lumen therealong, a second-catheter proximal portion, and a steerable second-catheter distal portion. The second catheter extends through the first lumen, such that the second-catheter proximal portion extends proximally out from the first-catheter proximal portion, the second-catheter distal portion extends distally out from the first-catheter distal portion, and within at least the first-catheter proximal portion, the first lumen and the second lumen are coaxial on a longitudinal axis. A first handle is coupled to the first-catheter proximal portion, and extends obliquely away from the first-catheter proximal portion at a nonzero angle with respect to the longitudinal axis. A second handle is coupled to the second-catheter proximal portion, and is disposed proximally from the first handle. Other embodiments are also described.

Controlled steering functionality for implant-delivery tool

An anchor-handling device comprises a housing shaped to define a channel having an anchor-storage zone and a proximal opening. An anchor driver comprises an anchor-engaging head, the anchor-engaging head being dimensioned to be advanceable through the proximal opening toward the anchor-storage zone. A tissue anchor is stored in the anchor-storage zone, and comprises a coupling head configured to be locked to the anchor-engaging head. The tissue anchor is movable out of the anchor-storage zone toward the proximal opening in response to a proximally-directed force being applied to the tissue anchor by the anchor driver. The anchor-handling device comprises an element that serves as an indicator of movement of the tissue anchor out of the anchor-storage zone toward the proximal opening, by moving in response to the proximally-directed force such that at least part of the element protrudes out of the housing. Other embodiments are also described.

A tube and a set of anchors, are transluminally advanced toward a heart of a subject. Tabs are distributed axially along an anchor storage area of the tube, each of the tabs protruding medially from a circumferential wall of the tube. The anchors are disposed in the anchor storage area, a first anchor engaged and restrained by a first tab at a first axial location of the tube, and a second anchor engaged and restrained by a second tab at a second axial location of the tube proximal from the first axial location. The first anchor is engaged by the driver at the first axial location, advanced to a distal end of the tube, and anchored to tissue of the heart. Subsequently, the second anchor is engaged by the driver at the second axial location, advanced to the distal end of the tube, and anchored to the tissue.

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Costa Mesa, CA, United States of America

Ehud Aviv