Low profile tissue anchors, tissue anchor systems, and methods for their delivery and use

Inventors

Ewers, Richard C. • Maahs, Tracy D. • Vong, Shirley

Assignees

USGI Medical Inc

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Publication Number

US-9572565-B2

Patent

Publication Date

2017-02-21

Expiration Date


Abstract

Tissue anchors include a flat, broad, and large contact surface for engagement with a portion of tissue. Several embodiments of composite tissue anchors include a support element and an overlay element. Tissue anchor assemblies include two or more tissue anchors, a connector, and a cinching mechanism. In some embodiments, the tissue anchors included in the tissue anchor assemblies are of different types, sizes, and/or shapes.

Core Innovation

The invention relates to a surgical tissue anchor assembly for translumenal/endoscopic use that includes low profile, deployable tissue anchors. The anchors include a flexible mesh pouch with a first collar at a first end and a second collar at a second end, and a frame within the flexible mesh pouch. The frame has longitudinal resilient struts flared radially outwardly so the tissue anchors are reconfigurable from a low profile delivery configuration to an expanded deployed position via outward movement of the resilient struts.

The tissue anchor assembly further includes a connector and a stop member on the connector that is not passable through the first tissue anchor. The connector passes through the flexible mesh pouch and not through the first and second collars, and in related configurations the connector also passes through a bar retained within the flexible mesh pouch. The first and second tissue anchors are slidable along the connector, enabling retention of the anchors at a controlled maximum distance during deployment and security of tissue folds.

The disclosed tissue anchors also use biocompatible/bioabsorbable woven mesh/biomaterials for the mesh pouch, and composite anchor configurations that combine mesh overlays with rigid struts and support structures such as T-bar, support ring, or frame elements. Delivery concepts include a needle deployment assembly with needle configurations intended to orient flat anchors and reduce pull-through risk after deployment, including needle features such as deflected points and side exit ports.

Claims Coverage

The partial content includes three independent claims, covering inventive tissue anchor assemblies and a single tissue anchor. The independent claims share the core concept of a low-profile to expanded deployed flexible mesh pouch with an internal resilient frame, plus a connector that passes through the mesh pouch (and optionally through a retained bar) and includes a connector stop member that is not passable through the first tissue anchor.

Low-profile to expanded tissue anchor assembly with resilient struts in a flexible mesh pouch

A first tissue anchor, a second tissue anchor, and a connector, where each tissue anchor includes a flexible mesh pouch with a first collar at a first end and a second collar at a second end; a frame within the flexible mesh pouch having longitudinal resilient struts flared radially outwardly to reconfigure from a low profile delivery configuration to an expanded deployed position via outward movement of the resilient struts; and a stop member on the connector not passable through the first tissue anchor.

Connector passage through mesh pouch and retained bar with slidable anchors

First and second tissue anchors each including a flexible mesh pouch and a frame retained within the flexible mesh pouch but not attached to the flexible mesh pouch, with the frame comprising longitudinal struts resiliently biased radially outwardly; the tissue anchors reconfigurable from a low profile delivery configuration to an expanded deployed position via the resilient bias; and the connector passing through the flexible mesh pouch of each of the first and second tissue anchors and through a bar retained within the flexible mesh pouch of each of the first and second tissue anchors, with the first and second tissue anchors slidable along the connector and the stop member not passable through the first tissue anchor.

Tissue anchor with resilient frame holding an expanded mesh pouch and suture through central bar opening

A surgical tissue anchor comprising a mesh pouch; a frame within the mesh pouch with longitudinal resilient struts projecting radially outwardly that hold the mesh pouch in an expanded position and allow the mesh pouch to be contractable into a low profile delivery position; a bar retained within the mesh pouch and not attached to the mesh pouch; and a suture passing through a central area of the mesh pouch and through an opening at a central area of the bar.

Across the independent claims, the inventive coverage centers on flexible mesh pouch tissue anchors that are reconfigurable between low profile delivery and an expanded deployed position using an internal resilient strut frame, and on a connector (including a stop member) that constrains anchor placement by passing through the mesh pouch and not through the collars, and optionally through a bar retained within the pouch, with slidable anchor interaction along the connector.

Stated Advantages

Reduces pull-through risk after deployment.

Distributes forces using flat, broad contact surfaces and helps reduce pull-through.

Eliminates projecting collars to better approximate thin tissue.

Enables a connector stop member that limits passage through the first tissue anchor.

Supports low-profile delivery and expanded deployed position reconfiguration of tissue anchors.

Documented Applications

Translumenal/endoscopic surgical use of low-profile, deployable tissue anchors and tissue anchor assemblies.

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