4Tech Inc.

Paolo Denti

Andrea Guidotti

Michael Gilmore

Kevin Lynn

Hugo Vanermen

Charlotte Murphy

John Matthew Mullins

Thomas Campbell

Idan Tobis

Francesco Maisano

Ottavio Alfieri

Mohamed Azeem Latib

David Zarbatany

Evin William Donnelly

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 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 tissue anchor includes a shaft, a tissue-coupling element, and a flexible elongate tension member. The tissue-coupling element includes a wire, which is shaped as an open loop having more than one turn when the tissue anchor is unconstrained. The tension member includes a distal portion that is fixed to a site on the open loop, a proximal portion, which has a longitudinal segment that runs alongside at least a portion of the shaft, and a crossing portion, which (i) is disposed between the distal and the proximal portions along the tension member, and (ii) crosses at least a portion of the open loop when the tissue anchor is unconstrained. The tissue anchor is configured to allow relative axial motion between the at least a portion of the shaft and the longitudinal segment of the proximal portion of the tension member when the tissue anchor is unconstrained.

Off-center tissue anchors with tension members

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 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.

A method of treating a heart of a patient is provided, including implanting a first tissue anchor in cardiac tissue of the patient, the first tissue anchor attached to one or more tethers that are fixed to a coupling element. A second tissue anchor is implanted in the patient. The coupling element is coupled to a first coupling site of the second tissue anchor, thereby coupling the first tissue anchor to the second tissue anchor via the 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 increased between the first and the second tissue anchors by decoupling the coupling element from the first coupling site and coupling the coupling element to a second coupling site of the second tissue anchor. Other embodiments are also described.

Post-implantation tension adjustment in cardiac implants

Apparatus for use with a deployment tool is provided. The apparatus includes a tissue anchor configured to be delivered in a constrained state within the deployment tool. The tissue anchor includes a shaft and a tissue-coupling element, which extends from a distal end of the shaft and is configured to be advanced through an incision in a wall of a cardiac chamber and be coupled to a far outer side of the wall. A spring is disposed proximal to a sealing element, and is configured to distally push the sealing element against an inner side of the wall to seal the incision. Other embodiments are also described.

Apparatus is provided that includes a casing, shaped to define a cavity, and one or more openings in the casing, in which openings one or more sutures are disposable; and a core, disposed in the cavity, and shaped to define a lumen in which the sutures are disposable. The apparatus has an unlocked configuration in which the sutures are disposable within and slidable through the openings and the lumen, and a locking configuration in which the sutures are inhibited from sliding through the openings and the lumen. The apparatus is movable from the unlocked configuration to the locking configuration, and is configured such that, when the sutures are disposed within the openings and the lumen, and the apparatus moves from the unlocked configuration to the locking configuration, the apparatus cuts the sutures at a cutting site, and becomes coupled to the sutures at a coupling site.

Suture-securing for cardiac valve repair

A tissue anchor () includes a shaft (), a tissue-coupling element (), and a flexible elongate tension member (). The tissue-coupling element () includes a wire (), which is shaped as an open loop () having more than one turn when the tissue anchor () is unconstrained. The tension member () includes a distal portion () that is fixed to a site () on the open loop (), a proximal portion (), which has a longitudinal segment () that runs alongside at least a portion () of the shaft (), and a crossing portion (), which (i) is disposed between the distal and the proximal N portions () along the tension member (), and (ii) crosses at least a portion of the open loop () when the tissue anchor () is unconstrained. The tissue anchor () is configured to allow relative axial motion between the at least a portion () of the shaft () and the longitudinal segment () of the proximal portion () of the tension member () when the tissue anchor () is unconstrained.

A method is provided including making an opening () through an atrial septum () at a septal site () at least 5 mm from a fossa ovalis (). A first tissue anchor () is endovascularly advanced to a left-atrial site () on an annulus of a mitral valve () or a wall of a left atrium () above the annulus. The first tissue anchor () is implanted at the left-atrial site (). A second tissue anchor () is endovascularly advanced to a right-atrial site () on an annulus of a tricuspid valve () or a wall of a right atrium () above the annulus. The second tissue () anchor is implanted at the right-atrial site (). The left-atrial site () and the right-atrial site () are approximated by tensioning a tether () that passes through the opening () of the atrial septum () and connects the first and the second tissue anchors (). Other embodiments are also described.

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Opera, Italy

Paolo Denti