Valtech Cardio Ltd.

Edwards Lifesciences Innovation (israel) Ltd.

G.i. View Ltd.

Edwards Lifesciences Innovation Ltd.

Tal Sheps

Tal Reich

Amir Gross

Oz Cabiri

Tal Hammer

Yuval Zipory

Yaron Herman

Eran Miller

Ehud Iflah

Meir Kutzik

Alexei Koifman

Ehud Aviv

Haim Brauon

Yossi Gross

Ilia Hariton

Yaron Keidar

Yosef Gross

Aviv Galon

Brian S Conklin

Boaz Manash

Rafael Pintor

Thomas V Doherty

Francesco Maisano

Ra'anan Gefen

Yoseph Weitzman

Uriel Aba Pomerantz

Brian Patrick Murphy

Ran Mendelewicz

Noam Kinrot

Or Cohen

Assaf Sharon

Tal Benshahar

Eran Hoffer

Amit Peer

Sarit Avivi

Reuven Eshel

Tomer Shoham

Gad Tennenbaum

Ido Halabi

Shlomit Chappel-Ram

Vadim Gordon

Roman Plut

Eva Cruz Romito

Lior Haroosh

Yuval Kasher

Or Chernin

Bezalel Haberman Browns

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

During a percutaneous transcatheter procedure, an annuloplasty structure is secured at least partially around an annulus of a mitral valve of a subject by coupling a plurality of tissue anchors to the annulus such that (i) a longitudinal contracting member of the annuloplasty structure extends at least partially around the annulus, and (ii) the plurality of tissue anchors is distributed at least partially around the annulus. A longitudinal density of the anchors along a middle scallop of a posterior leaflet of the mitral valve is at least twice as great as a longitudinal density of the anchors along a lateral scallop of the posterior leaflet, and/or at least twice as great as a longitudinal density of the anchors along a medial scallop of the posterior leaflet. Thereafter, at least part of the annulus is contracted by contracting a longitudinal portion of the annuloplasty structure by tightening the longitudinal contracting member.

Percutaneous implantation of an annuloplasty structure

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

Apparatus is provided for repairing a cardiac valve, the apparatus including a catheter sized for delivery through vasculature of a subject and an elongated and flexible annuloplasty structure having an annuloplasty structure axis. The annuloplasty structure is sized and configured for delivery to a heart of the subject through the catheter substantially along a catheter axis of the catheter while the annuloplasty structure axis is substantially parallel to the catheter axis. The apparatus also includes a plurality of anchors configured for delivery to a region of cardiac tissue from a proximal end of the catheter toward a distal end of the catheter and substantially along the annuloplasty structure axis and the catheter axis while at least a portion of the annuloplasty structure is within a delivery passage of the catheter. Other embodiments are also described.

Annuloplasty ring delivery catheters

An implant structure, comprises a body portion, a first adjusting mechanism, and a second adjusting mechanism. The body portion is configured to be secured within a heart of a patient. The first adjusting mechanism is coupled to a first portion of the body portion, and comprises a first ring that surrounds the first portion and is moveable with respect to the body portion. The second adjusting mechanism is coupled to a second portion of the body portion, and comprises a second ring that surrounds the second portion and is moveable with respect to the body portion. A first elongate tool is configured to remodel tissue of the heart by actuating the first adjusting mechanism. A second elongate tool is configured to remodel tissue of the heart by actuating the second adjusting mechanism.

Implant having multiple adjusting mechanisms

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 annuloplasty implant comprises a flexible member, helical anchors, and non-compressible portions. The helical anchors are configured to anchor the flexible member at least partway around the valve by being screwed into tissue of the heart of a subject. Each of the non-compressible portions comprises a helical coil having a plurality of turns, and at rest has a helix pitch that contacts each turn of the coil with an adjacent turn of the coil. The flexible member extends through the non-compressible portions. The implant is configured such that applying tension to the flexible member from one end thereof contracts the implant, thereby drawing the anchors closer to each other, the helical coil of each of the non-compressible portions inhibiting contraction of the implant at the non-compressible portion.

Adjustable annuloplasty devices and adjustment mechanisms therefor

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 method for use with a heart of a subject includes advancing a tool distally along a flexible elongate contracting member, toward an anchor implanted at the heart. Tension is applied to the contracting member such that the contracting member slides proximally through a fastener disposed at the heart while a stop coupled to the fastener maintains the fastener in an open state. Using the tool, the stop is pulled proximally (i) away from the fastener, such that the fastener responsively clamps to the contracting member, thereby locking the tension in the contracting member, and (ii) against a cutting element of the tool such that the cutting element moves in a manner that severs the contracting member. Other embodiments are also described.

Fastener and techniques therefor

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 annuloplasty implant comprises an elongate member, a plurality of anchors, and a gripper. The elongate member has a proximal end, and a distal portion that includes a distal end. The plurality of anchors are distributed along the elongate member. The elongate member extends proximally from a proximal-most anchor and through the gripper. The gripper comprises a locking element that, in a locked state, inhibits sliding of the elongate member through the gripper. An unlocker, disposed within the gripper, obstructs the locking element from assuming the locked state, and is pullable proximally out of the gripper. The gripper automatically assumes the locked state upon the unlocker being pulled proximally out of the gripper. A tool tensions the distal portion of the elongate member by pulling the elongate member proximally through the gripper while the unlocker obstructs the locking element from assuming the locked state. Other embodiments are also described.

Implant-cinching devices and systems

A tissue-engaging element has a distal portion configured to engage a portion of tissue of the heart. A guide member is reversibly coupled to the tissue-engaging element. An elongate implant has a distal end and a proximal end, at least the distal end being slidably coupled to the guide member. A tool is slidable along the guide member distally toward the tissue-engaging element while (i) the tool is coupled to at least the distal end of the elongate implant, and (ii) the guide member is coupled to the tissue-engaging element, such that sliding of the tool along the guide member distally toward the tissue-engaging element while (i) the tool is coupled to at least the distal end of the elongate implant, and (ii) the guide member is coupled to the tissue-engaging element, slides at least the distal end of the elongate implant toward the tissue-engaging element.

Apparatus and method for guide-wire based advancement of an adjustable implant

An implant structure, comprises a body portion, a first adjusting mechanism, and a second adjusting mechanism. The body portion is configured to be secured around an annulus of a native valve of a heart of a patient. The first adjusting mechanism is coupled to a first portion of the body portion, and comprises a first ring that surrounds the first portion and is moveable with respect to the body portion. The second adjusting mechanism is coupled to a second portion of the body portion, and comprises a second ring that surrounds the second portion and is moveable with respect to the body portion. A first elongate tool is configured to remodel tissue of the heart by actuating the first adjusting mechanism. A second elongate tool is configured to remodel tissue of the heart by actuating the second adjusting mechanism.

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Giv′at-Shmuel, Israel

Tal Sheps