4tech Inc.

Merit Medical Ireland Limited

Michael Gilmore

Charlotte Murphy

Kevin Lynn

Andrea Guidotti

Paolo Denti

Idan Tobis

John Matthew Mullins

Thomas Campbell

Hugo Vanermen

Mohamed Azeem Latib

Francesco Maisano

Ascher Shmulewitz

David Zarbatany

Menashe Yacoby

Damian Kelly

David Slattery

Gil Naor

Mark Steckel

Raz Bar-On

Gareth Clarke

Therese O'Connor

Evin William Donnelly

Chris Moran

John Mullins

Gabriel Sobrino-Serrano

Joseph Kerins

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 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 system for repairing an atrioventricular valve of a patient is provided. First and second tissue-engaging elements are configured for implantation at first and second implantation sites of the patient, respectively. First and second flexible longitudinal members are coupled at respective first end portions thereof to the first and the second tissue-engaging elements, respective. Each of the first and the second flexible longitudinal members comprises a braided polyester suture or a plurality of wires that are intertwined to form a rope structure. First and second flexible-longitudinal-member-coupling elements are coupled to respective second end portions of the first and the second flexible longitudinal members. The first and the second flexible-longitudinal-member-coupling elements are configured to be couplable together during an implantation procedure to couple together the first and the second flexible longitudinal elements.

Atrioventricular valve repair using tension

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 is provided that includes a tissue anchor, which (a) includes a helical tissue-coupling element which has a distal tissue-penetrating tip at a distal end of the tissue anchor, and which is configured to be advanced into soft tissue, and (b) is shaped so as to define a longitudinal channel extending to the distal end of the tissue anchor. The apparatus further includes a depth-finding tool, which includes a radiopaque bead that is axially moveable along the channel so as to serve as a marker indicating a depth of penetration of the tissue-coupling element into the soft tissue.

Soft tissue depth-finding tool

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 delivery system that includes a catheter, a balloon, a self-expanding prosthesis, and a sheath. The sheath including an opening in a wall of the sheath that initiates rupturing of the sheath so that the self-expanding prosthesis may move from its compressed state to its expanded state. Additionally, a distal end portion of the balloon that is distal to a distal end of the sheath includes an enlarged diameter portion, the enlarged diameter portion having approximately the same outer diameter as an outer diameter of the sheath when the self-expanding prosthesis is in its compressed state, and the enlarged diameter portion being the maximum outer diameter of the balloon when the self-expanding prosthesis is in its compressed state.

Delivery system and method of use for deployment of self-expandable vascular device

A method is provided that includes implanting (a) a venous first tissue anchor in a vein selected from the group of veins consisting of: a superior vena cava and an inferior vena cava, (b) an atrial second tissue anchor at an atrial site selected from the group of sites consisting of: an annulus of a tricuspid valve, and a wall of a right atrium of a heart above the annulus of the tricuspid valve, (c) a venous third tissue anchor in a coronary sinus, and (d) one or more tethers, which connect the venous first tissue anchor, the atrial second tissue anchor, and the venous third tissue anchor. A size of a tricuspid orifice is reduced by tensioning the one or more tethers. Other embodiments are also described.

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Ardrahan, Ireland

Michael Gilmore