Trans-catheter ventricular reconstruction structures, methods, and systems for treatment of congestive heart failure and other conditions

Inventors

Van Bladel, Kevin • Annest, Lon • Sheldon, Murray • Heflin, Ernie • Wechsler, Andrew • Stiggelbout, John • Arcia, Rovil • Bower, John

Assignees

Bioventrix Inc

Abstract

Embodiments described herein include devices, systems, and methods for reducing the distance between two locations in tissue. In one embodiment, an anchor may reside within the right ventricle in engagement with the septum. A tension member may extend from that anchor through the septum and an exterior wall of the left ventricle to a second anchor disposed along a surface of the heart. Perforating the exterior wall and the septum from an epicardial approach can provide control over the reshaping of the ventricular chamber. Guiding deployment of the implant from along the epicardial access path and another access path into and through the right ventricle provides control over the movement of the anchor within the ventricle. The joined epicardial pathway and right atrial pathway allows the tension member to be advanced into the heart through the right atrium and pulled into engagement along the epicardial access path.

Core Innovation

The described invention provides a system for treating a heart within a patient by reducing the distance between the septum and the left-ventricular exterior wall through minimally invasive ventricular reconstruction for congestive heart failure. The system uses an implant that includes a first anchor positionable against the septum, a second anchor, and a tension member having ends coupleable with the first and second anchors. Applying tension between the anchors via the tension member urges the septum and the exterior wall of the left ventricle into engagement.

To establish a path that enables the implant to apply tension across the septum and the left-ventricle exterior wall, the system includes catheter and needle arrangements that position components in the right ventricle. A needle penetrates an exterior wall of the left ventricle and through the septum so that a distal end is disposed in the right ventricle, and a second catheter is advanced through penetrations in the left ventricle exterior wall and the septum so that its distal end is disposed in the right ventricle. A coupling member couples first and second members to form a path from outside the patient through the septum and left-ventricle exterior wall back to outside the patient.

Deployment is described with an implant tensioning approach that includes epicardial engagement using a second anchor. The system controls epicardial perforation by simultaneously joining an epicardial access path with a separate right-atrial/right-ventricle access path, enabling guidewire/snare coupling and controlled anchor movement without complex intracardiac catheter steering. Migration inhibition and anchoring force control are described with a variable-force mode and a set-force mode to maintain a desired engagement force on a beating heart.

Claims Coverage

Independent claim coverage is provided by two independent claims. Each claim centers on forming a path through the septum and left-ventricle exterior wall and using an implant with first and second anchors and a tension member to urge specified ventricular walls into engagement, with claim-specific recitations of catheters, needle arrangements, and anchor/tension behaviors.

Across both independent claims, the core claim structure is the same: a system forms a path through the septum and left-ventricle exterior wall using catheters, needle, and a coupling member, and an implant with a tension member and first and second anchors applies tension so the septal wall and the left ventricle wall or exterior wall are urged into engagement, with claim 13 further emphasizing a slidably coupleable second anchor and achievable anchor force.

Stated Advantages

Documented Applications