Heart anchor positioning devices, methods, and systems for treatment of congestive heart failure and other conditions

Inventors

Van Bladel, Kevin • Annest, Lon • Heflin, Ernest • Mata, Gilbert • Crainich, Lawrence • LaRose, Brian

Assignees

Bioventrix Inc

Abstract

According to one embodiment, a heart anchor tensioning device includes a main body and an elongate shaft. A tension member or tether may be inserted through a lumen of the elongate shaft to allow the shaft to be advanced over the tension member and within a body while the main body is positioned outside of the body. The device also includes an anchor coupling mechanism that is configured to engage a heart anchor and move the heart anchor into engagement with a first wall of the heart. The anchor coupling mechanism is able to lock the heart anchor to inhibit proximal movement of the heart anchor along the tension member. The device further includes a tension indicating mechanism that provides an indication of a force being applied to the heart anchor by the device.

Core Innovation

The invention relates to a heart anchor positioning device for use in congestive heart failure, where a device body is coupled to an elongate shaft that includes a lumen between a proximal end and a distal end. A tension member is insertable through the lumen so the device is advanced over the tension member while the distal end is insertable within a body adjacent the heart and the device body remains outside of the body.

An anchor coupling mechanism at the distal end engages a heart anchor to move the heart anchor distally along the tension member into engagement with a first wall of the heart to urge the first wall toward a second wall of the heart. The anchor coupling mechanism is configured to lock the heart anchor to inhibit proximal movement of the heart anchor along the tension member, and is further configured to apply a pulling force to unlock the heart anchor to enable proximal movement of the heart anchor.

The device includes a tension indicating mechanism configured to indicate a force being applied to the heart anchor by the device, including embodiments with a first mode that urges the heart wall without indicating the applied force and a second mode that indicates the force being applied during a tensioning operation. In additional embodiments, the invention is described as a heart implant system and method that deploy a first anchor and a second anchor on opposed heart walls and advance a tensioning device over a tether to apply a desired anchor force while providing force indication.

The system is described with a transition in which a locking mechanism is actuated to transition a second anchor from a variable-force mode to a set-force mode to restrict proximal sliding. The document further describes supporting system components for trans-wall access and deployment, including a tissue penetrating device with coaxially aligned inner and outer needles, an outer needle formed from a shape-memory material to accommodate bending to an offset septal or external wall entry point, and optional pressure sensing for locating penetration within heart structures.

Claims Coverage

The independent claim provides a heart anchor positioning device with four main inventive elements: an elongate shaft lumen with a tension member to advance the device over the tension member, an anchor coupling mechanism that urges one heart wall toward another and includes locking/inhibition plus unlocking via pulling force, and a tension indicating mechanism that indicates force applied to the heart anchor.

Overall, the claim coverage centers on a device that advances over a tension member, uses a distal anchor coupling mechanism to urge opposed heart walls while locking and unlocking the heart anchor to inhibit and then permit proximal movement, and includes a tension indicating mechanism that indicates the applied force.

Stated Advantages

Documented Applications