Valtech Cardio Ltd.

Edwards Lifesciences Innovation (israel) Ltd.

Cardiovalve Ltd.

Cardiovale Ltd.

Mitraltech Ltd. 3 Ariel Sharon Avenue

Edwards Lifesciences Innovation Ltd.

Yaron Herman

Tal Reich

Tal Hammer

Yuval Zipory

Tal Sheps

Ehud Iflah

Eran Miller

Amir Gross

Alexei Koifman

Oz Cabiri

Yoseph Weitzman

Yossi Gross

Ilia Hariton

Meni Iamberger

Ehud Aviv

Natalia Kruglova

Francesco Maisano

Meir Kutzik

Haim Brauon

Uriel Aba Pomerantz

Aviram Baum

Michael Albitov

Eran Hoffer

Slava Starobinsky

Gil Hacohen

Rotem Neeman

Boaz Manash

Yosef Gross

Or Cohen

Yuval Kasher

Assaf Sharon

Tai Reich

Aviv Galon

Sarit Avivi

Amit Peer

Tomer Shoham

Tal Benshahar

Ido Halabi

Shlomit Chappel-Ram

Vadim Gordon

Gad Tennenbaum

Eva Cruz Romito

Lior Haroosh

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

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 Subsequently, the frame is contracted and withdrawn from the subject while leaving the annuloplasty structure anchored around the annulus.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

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 prosthetic valve includes a tubular valve body, snares, and an upstream support. A native valve of a heart of a subject is disposed between an atrium and a ventricle of the heart, and has an annulus and leaflets. The prosthetic valve is advanced to the heart while in a compressed state. The prosthetic valve is positioned within the heart such that the snares are disposed upstream of the annulus and leaflets. The snares are expanded radially outwardly upstream of the leaflets. Subsequently, the prosthetic valve is moved in a downstream direction such that the snares become disposed downstream of the leaflets. While the snares remain downstream of the leaflets, the upstream support is expanded within the atrium, and the upstream support is placed against an upstream surface of the annulus. Other embodiments are also described.

Anchoring of a prosthetic valve

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 prosthetic heart valve implant is provided including a frame shaped so as to define upstream and downstream openings at upstream and downstream ends of the frame, respectively, when the implant is in an expanded state for implantation at a heart native valve. A sheet is coupled to the frame. When the implant is in the expanded state, the frame is shaped so as to define the following longitudinal portions arranged along a central longitudinal axis of the prosthetic heart valve implant: a substantially cylindrical mid portion having a diameter greater than respective diameters of the upstream and the downstream ends of the frame; an upstream portion, extending upstream and radially inward from the mid portion; and a downstream portion, extending downstream and radially inward from the mid portion. Other embodiments are also described.

Prosthetic heart valve implant

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

Apparatus is provided, including an implant including a tissue-adjusting member including a longitudinal member, and a tissue anchor coupled to the tissue-adjusting member and configured to be anchored into the tissue of the patient. A tissue-coupling element is coupled to the longitudinal member. A delivery tool is reversibly couplable to the implant and is configured to deliver the implant to the tissue of the patient. The delivery tool includes an elongate shaft, a tissue-coupling-element holder coupled to a portion of the elongate shaft, the tissue-coupling-element holder being configured to hold the tissue-coupling element during delivery of the implant to the tissue of the patient, and an actuating element configured to rotate the tissue anchor so as to facilitate anchoring of the tissue anchor into the tissue of the patient while not rotating the tissue-coupling-element holder with respect to the shaft.

Systems and methods for tissue adjustment

An example anchor-manipulation tool includes (i) at a distal portion of the tool, an anchor-engaging element and an actuator, (ii) at an extracorporeal proximal portion of the tool, a controller, and (iii) a flexible longitudinal member extending between the proximal portion and the distal portion. The distal portion of the tool can be transluminally advanced to an anchor that is intracorporeally implanted in a subject. Subsequently, the anchor-engaging element can be engaged with an eyelet defined by a head of the anchor. Subsequently, the controller can be used to transition the tool into an articulatably-coupled state in which: (i) the eyelet at least in part inhibits movement of the anchor-engaging element away from the anchor, and (ii) the distal portion of the anchor-manipulation tool is deflectable with respect to the anchor. Subsequently, the anchor can be de-anchored by using the anchor-manipulation tool to apply a de-anchoring force to the eyelet.

Apparatus is provided, including: (A) a valve body () including a first frame () shaped to define a lumen therethrough, and a valve member () disposed within the lumen, (B) an upstream support (), configured to be placed against an upstream surface of a native heart valve, and (C) a flexible sheet () that couples the upstream support to the valve body. The valve body has a compressed state in which the first frame has a first diameter, and an expanded state in which the first frame has a second diameter that is greater than the first diameter. The support includes a second frame () that has a compressed state, and an expanded state in which the second frame is annular, has an inner perimeter that defines an opening through the second frame, and has an outer perimeter. Other embodiments are also described.

Prosthetic valve and upstream support therefor

A linking member extends from a first linking site of a longitudinal member to a second linking site of the longitudinal member. An anchor driver is configured to anchor portions of the longitudinal member to tissue using tissue anchors. A distal portion is anchorable to a first tissue location while the first linking site is within a catheter. While the distal portion is anchored to the first location, and the second linking site is within the catheter, a second portion is advanceable distally out of the catheter and is anchorable to a second tissue location. While the second portion is anchored to the second location, the second linking site and a third portion are advanceable distally out of the catheter. After the second linking site has been advanced out of the catheter, the third portion is anchorable to a third tissue location. Other embodiments are also described.

Leaflet-restraining techniques

An anchor includes (a) an anchor head; and (b) a tissue-engaging member extending distally away from the anchor head until a distal tip of the tissue-engaging member, and configured to anchor the anchor to tissue. An anchor driver can include (a) a longitudinal shaft, having a flexible distal portion and a distal end; (b) a deployment element at the distal end of the shaft, reversibly lockable to the anchor head, and reversibly movable between (i) a locked state that retains locking between the deployment element and the anchor head, and (ii) an unlocked state that unlocks the deployment element from the anchor head; and (c) a tissue-piercing lance, reversibly movable between (i) an extended state in which the lance extends distally from the shaft past the distal tip of the anchor, and retains the deployment element in the locked state, and (ii) a retracted state in which the deployment element automatically moves into the unlocked state.

Controlled steering functionality for implant delivery tool

Apparatus is provided including a percutaneously-implantable implant and an adjustment device. The adjustment device can comprise an adjustment mechanism, coupled to the implant, and configured to change a dimension of the implant upon actuation of the adjustment mechanism and a lock. The adjustment device can have a locked state in which the lock inhibits actuation of the adjustment mechanism and an unlocked state in which the adjustment mechanism is actuatable. The adjustment device can be reversibly movable between the locked state and the unlocked state. The apparatus can include a longitudinal guide member and an adapter. An unlocking mechanism can be configured such that, while the adapter is coupled to the adjustment device, actuation of the unlocking mechanism moves the lock between the locked state and the unlocked state. Other applications are also described.

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Givat Ada, Israel

Yaron Herman