4tech Inc.

Thomas Campbell

Michael Gilmore

Charlotte Murphy

Paolo Denti

Kevin Lynn

Andrea Guidotti

Hugo Vanermen

John Matthew Mullins

Idan Tobis

Evin William Donnelly

John Mullins

Gabriel Sobrino-Serrano

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 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 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.

Growing community of inventors

County Mayo, Ireland

Thomas Campbell