4Tech Inc.

Hugo Vanermen

Andrea Guidotti

Paolo Denti

Michael Gilmore

Charlotte Murphy

Kevin Lynn

John Matthew Mullins

Thomas Campbell

Francesco Maisano

Idan Tobis

Ottavio Alfieri

Valery Perevalov

Gabriel Sobrino-Serrano

Rephael Hof

Evin William Donnelly

Repheal Hof

John Mullins

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 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 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.

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.

A method is provided of reducing tricuspid valve regurgitation of a patient. A first tissue anchor is implanted at a first implantation site in cardiac tissue in the vicinity of the tricuspid valve of the patient. A second tissue anchor is implanted at a second implantation site of the patient, different from the first implantation site. After the first and the second tissue anchors have been implanted, a longitudinal member that couples the first and the second tissue anchors together is longitudinally deflected.

Tricuspid valve repair using tension

A method is provided for repairing the tricuspid valve of a patient using tension. A radially-expandable stent is implanted in a coronary sinus of the patient. A tissue anchor is implanted in tissue in the vicinity of the tricuspid valve. The tricuspid valve is repaired by applying tension between the radially-expandable stent and the tissue anchor using a flexible longitudinal member that connects the radially-expandable stent and the tissue anchor.

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.

Techniques are described for use with one or more sutures. For some applications, techniques are described for fixedly-coupling two or more sutures to each other. For some applications, such techniques are used for treating a heart valve of a subject. Techniques are also described for treating a heart valve of a subject by coupling leaflets of the heart valve to a support using tissue-piercing elements. Other embodiments are also described.

Heart valve repair system

A method is provided, including implanting at least a first tissue-engaging element in a first portion of tissue in a vicinity of a heart valve of a patient, implanting at least a second tissue-engaging element in a portion of a blood vessel that is in contact with an atrium of a heart of the patient, and drawing at least a first leaflet of the valve toward at least a second leaflet of the valve by adjusting a distance between the portion of the blood vessel and the first portion of tissue in the vicinity of the heart valve of the patient. Other applications are also described.

Growing community of inventors

Knocke-le-Zoute, Belgium

Hugo Vanermen