4tech Inc.

Unversität Zürich

Sv Swissvortex Ltd.

Mtex Cardio Ag

Coremedic Gmbh

Andrea Guidotti

Paolo Denti

Michael Gilmore

Kevin Lynn

Hugo Vanermen

John Matthew Mullins

Charlotte Murphy

Thomas Campbell

Idan Tobis

Francesco Maisano

David Zarbatany

Boaz Harari

Ricardo David Roman

Silvio Schaffner

Yaniv Marmur

Ottavio Alfieri

Thomas Bauer

Gabriel Sobrino-Serrano

Karl Heinz Kuck

Mohamed Azeem Latib

Pietro Gozzoli

Georgios Stefopoulos

Chris Moran

Jesus Flores

Evin William Donnelly

Luca Vicentini

Monica Tocchi

Tommaso Sironi

Mattia Arduini

Michael Roth

John Mullins

Michael Butscheid

An occlusion device is provided for occluding a left atrial appendage (LAA), including a compliant balloon defining a fluid-tight balloon chamber. An actuating shaft is disposed at least partially within the balloon chamber, and configured to set a distance between distal and proximal end portions of the balloon. A locking mechanism is configured to assume locked and unlocked states, and is configured, when in the locked state, to maintain, between the distal and the proximal end portions of the balloon, the distance set using the actuating shaft. The occlusion device is shaped so as to define a fluid flow path along a portion of the actuating shaft. A valve is configured to selectively allow or block fluid flow between the fluid flow path and the balloon chamber when the valve is in open and closed states, respectively. Other embodiments are also described.

Left atrial appendage occlusion devices

An occlusion device () includes a compliant balloon () including an inflation port () for filling and unfilling a fluid into and from a balloon chamber (). A distal tip element () and a proximal base element () are disposed at distal and proximal sides (B,A) of the balloon (), respectively. An elongate actuating element () is disposed longitudinally slidable in a balloon lumen () forming a longitudinal passage () from the proximal side (A) to the distal side (B) of the balloon (), connected to the distal tip element (), and longitudinally moveable with respect to the proximal base element () so as to set a distance between the distal tip element (and the proximal base element (). A locking mechanism () is configured to maintain, between the distal tip element () and the proximal base element (), the distance set using the elongate actuating element ().

Medical occlusion device

A tissue anchor system is provided that includes a first tissue anchor, a second tissue anchor that is separate and distinct from the first tissue anchor, and one or more tethers, which are configured to couple the first tissue anchor to the second tissue anchor. When the first tissue anchor is unconstrained, a head thereof is coaxial with an axis of a shaft thereof, and a tissue-coupling element thereof extends from a distal end of the shaft, is generally orthogonal to the axis, and is shaped such that if the tissue-coupling element were to be projected onto a plane that is perpendicular to the axis, at least 80% of an area of a projection of the tissue-coupling element on the plane would fall within a first angle of 180 degrees in the plane having a vertex at the axis. Other embodiments are also described.

Off-center tissue anchors

A surgical fastener instrument () includes an outer delivery tube (); an inner delivery shaft (), disposed at least partially in the outer delivery tube (); and a handle () coupled to a proximal portion () of the outer delivery tube (), and including a user control element () arranged to rotate the inner delivery shaft () with respect to the outer delivery tube (). A suture fastener () is removably disposed in the outer delivery tube () in an unlocked conical helical configuration. Distal advancement of the inner delivery shaft (), when one or more portions of one or more sutures () pass through respective portions of the suture fastener (), transitions the suture fastener () from the unlocked configuration to a locked planar spiral configuration, in which the one or more sutures () are fixedly coupled to the suture fastener (). Other embodiments are also described.

Suture fasteners

An occlusion device () is provided for occluding a left atrial appendage (LAA), including a compliant balloon () defining a fluid-tight balloon chamber (), and an actuating shaft (), which is disposed at least partially within the balloon chamber () for setting a distance between distal and proximal end portions () of the balloon (). A proximal LAA-orifice cover () includes a frame () and a covering () fixed to the frame (). An orifice-support stent () is fixed to and extends distally from the proximal LAA-orifice cover (), and is generally cylindrical when in a radially-expanded state. Other embodiments are also described.

An occluder device is provided for occluding a cardiovascular defect or a gap between a medical device and adjacent body tissue, the device including a compliant balloon defining a fluid-tight balloon chamber and a balloon channel forming a longitudinal passage from a proximal to a distal side of the balloon, the balloon including a fluid port for filling a fluid into the balloon chamber. A tip and a base are coupled to the distal and the proximal sides of the balloon, respectively. At least one connecting strut is attached to the tip and to the base. An elongate actuator is disposed longitudinally slidable in the balloon channel and connected to the tip, and longitudinally slidable with respect to the base so as to set a distance between the tip and the base. A lock is configured to maintain the distance between the tip and the base. Other embodiments are also described.

Medical occluder device

A tissue anchor is provided that includes a head connected to a shaft, and a tissue-coupling element extending from the shaft. The shaft includes a seal that is configured to form a blood-tight seal between the shaft and a heart wall, and to promote hemostasis. When the tissue anchor is unconstrained, the head is coaxial with an axis of the shaft, and the tissue-coupling element is generally orthogonal to the axis and is shaped such that if the tissue-coupling element were to be projected onto a plane that is perpendicular to the axis, at least 80% of an area of a projection of the tissue-coupling element on the plane would fall within a first angle of 180 degrees in the plane having a vertex at the axis. Other embodiments are also described.

A tissue anchor is provided for delivery by a deployment tool in a constrained state, the tissue anchor including a shaft; a tissue-coupling element, which includes a wire including a shape-memory alloy; and a flexible elongate tension member, which is distinct from the wire. The flexible elongate tension member includes a distal portion that is fixed to a site on the wire such that, when the tissue anchor is not constrained by the deployment tool, the flexible elongate tension member applies, to the tissue-coupling element, tension that constrains lateral expansion of the tissue-coupling element away from a central longitudinal axis of the shaft, by preventing the tissue-coupling element from automatically assuming a predetermined shape provided by the shape-memory alloy of the wire. Other embodiments are also described.

A method is provided including introducing, during a transcatheter procedure, a tissue anchor into a cardiac chamber of a heart of a subject, while a tissue-coupling element of the tissue anchor is constrained by a deployment tool. The tissue-coupling element is delivered distally through a cardiac wall. The tissue anchor is at least partially released from the deployment tool such that the tissue-coupling element is unconstrained by the deployment tool. After the tissue-coupling element is delivered through the cardiac wall and the tissue anchor is at least partially released from the deployment tool, whether the tissue-coupling element overlies a coronary blood vessel is ascertained, and, if the tissue-coupling element overlies the coronary blood vessel, the tissue anchor is rotated until the tissue-coupling element no longer overlies the coronary blood vessel. Thereafter, the tissue-coupling element is proximally pulled by applying tension to the tissue anchor. Other embodiments are also described.

A suture-securing device includes a first tubular element, shaped to define a first lumen therethrough, and having first and second ends; and a second tubular element, shaped to define a second lumen therethrough, and having first and second ends. The suture-securing device is configured to have (a) an unlocked configuration in which the first end of the second tubular element is disposed closer to the first end of first tubular element than is the second end of the second tubular element, and the sutures are disposable within and slidable through the first and second lumens, and (b) a locking configuration in which the second end of the second tubular element is disposed closer to the first end of first tubular element than is the first end of the second tubular element, and the sutures are inhibited from sliding through the first and second lumens. Other embodiments are also described.

Suture-securing device

A tissue anchor is provided that is configured to be delivered in a constrained state within a deployment tool. The tissue anchor includes a shaft and a tissue-coupling element, which (a) extends from a distal end of the shaft, and (b) is configured to be advanced through a heart wall and be coupled to a far side of the heart wall. The tissue anchor further includes a sealing element, which is (a) disposed around the shaft, (b) sized and shaped to be disposed entirely within the heart wall, and (c) configured to promote hemostasis. Other embodiments are also described.

Tissue anchors with hemostasis seal

A method of treating a heart of a patient is provided. The method includes implanting a first tissue anchor in cardiac tissue of the patient and a second tissue anchor in the patient, such that the first and the second tissue anchors are coupled together by one or more tethers. Thereafter, after allowing at least 24 hours for tissue growth on the first tissue anchor to strengthen anchoring of the first tissue anchor in the cardiac tissue, tension is applied between the first and the second tissue anchors using at least a longitudinal portion of the one or more tethers. Other embodiments are also described.

Post-implantation tensioning in cardiac implants

A torque-delivery tool includes a cable and a distal coupling element. A tissue anchor includes an anchor head, which includes a shaft having a proximal coupling element. The distal and proximal coupling elements are shaped so as to define corresponding interlocking surfaces. An outer tether-securing element of the anchor is shaped so as to define a lateral opening through which a tether is disposed, and at least partially radially surrounds the shaft and a spring. In an unlocked state, a distal spring depressor restrains the spring in an axially-compressed state. In a locked state, the distal and proximal coupling elements are not coupled with one another, the distal spring depressor does not restrain the spring in the axially-compressed state, and the spring is in an axially-expanded state, in which the spring inhibits the sliding of the tether through the lateral opening by pressing the tether against the outer tether-securing element.

Cardiac tissue cinching

A tissue anchor is provided that includes a head connected to a shaft, and a tissue-coupling element extending from the shaft. When the tissue anchor is unconstrained, the head is coaxial with an axis of the shaft, and the tissue-coupling element is generally orthogonal to the axis and is shaped such that if the tissue-coupling element were to be projected onto a plane that is perpendicular to the axis, (a) at least 80% of an area of a projection of the tissue-coupling element on the plane would fall within a first angle of 180 degrees in the plane having a vertex at the axis, and (b) the area would partially overlap, at least 3 mm from the vertex, both rays of a second angle of between 45 and 180 degrees in the plane having the vertex at the axis. Other embodiments are also described.

A tissue anchor is provided for delivery in a constrained state within a deployment tool. The tissue anchor includes a tissue-coupling element; a flexible elongate tension member, which includes (a) a distal portion that is fixed to a site on the tissue-coupling element, and (b) a proximal portion, which is slidably disposed through a passage defined by the tissue anchor; and a load-limiting element, which is attached to the flexible elongate tension member. The load-limiting element and the passage are sized and shaped such that the size and shape of the passage prevent proximal movement of the load-limiting element past the passage, such that the load-limiting element limits a total load that can be applied to the tissue-coupling element by the flexible elongate tension member.

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Zurich, Switzerland

Andrea Guidotti