4tech Inc.

Aerami Therapeutics, Inc.

Dance Biopharm Inc.

John Matthew Mullins

Michael Gilmore

Andrea Guidotti

Paolo Denti

Kevin Lynn

Charlotte Murphy

Hugo Vanermen

Thomas Campbell

Ronan MacLoughlin

Kieran James Hyland

Jim Fink

Lisa Molloy

Michael Joseph Casey

Claire Elizabeth Lillis

Joseph Martin Grehan

Francesco Maisano

David Zarbatany

Mohamed Azeem Latib

Niall Scott Smith

Joe Grehan

Clair Elizabeth Lillis

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.

In one aspect, embodiments of the present invention provide an aerosolization device for ensuring proper delivery of an aerosolized medication to a user's respiratory system. The aerosolization device may include a conduit, an aerosol generator, a restrictor disposed within the conduit, and an indicator mechanism. The conduit may include a mouthpiece end by which a user may cause inspiratory flow through the conduit. The aerosol generator may include a vibratable mesh. The restrictor may define a plurality of apertures disposed along an outer periphery of the restrictor configured to provide an increase in pressure differential that varies with an inspiratory flow rate within the conduit and to provide a relatively laminar flow downstream of the restrictor compared to upstream of the restrictor. The indicator mechanism may indicate to a user a state of a parameter of the inspiratory flow relative to a predefined desired range.

Aerosolization system with flow restrictor and feedback 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

Embodiments provide aerosolization device for providing aerosolized medicament to user. The aerosolization device includes conduit, aerosol generator, fluid receiving chamber, restrictor within the conduit, and indicator mechanism. Conduit has an inner wall and a mouthpiece end for causing an inspiratory flow. Aerosol generator includes a vibratable mesh laterally offset from the inner wall. Fluid receiving chamber receives liquid medicament. At least a portion of chamber is tapered such that liquid medicament is directed onto vibratable mesh for aerosolization. Restrictor defines a plurality of apertures that provide increases in pressure differential that vary with inspiratory flow rate within conduit and provide relatively laminar flow downstream of restrictor. Indicator mechanism indicates a state of flow parameters relative to a predefined range. Aerosol generator is configured to aerosolize at least a portion of liquid medicament only when flow parameters of the inspiratory flow are within range.

Liquid nebulization systems and methods

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.

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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Tuam, Ireland

John Matthew Mullins