Over-the-wire cardiac implant delivery system for treatment of CHF and other conditions

Inventors

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

Assignees

Bioventrix Inc

Abstract

Medical devices, systems, and methods reduce the distance between two locations in tissue in a minimally invasive manner, often for treatment of congestive heart failure. In one embodiment, an anchor of an implant system may, when the implant system is fully deployed, reside within the right ventricle in engagement with the ventricular 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 an epicardial surface of the heart. Deployment of the anchor within the right ventricle may be performed by inserting a guidewire through the septal wall into the right ventricle. The anchor may be inserted into the right ventricle over the guidewire and through a lumen of a delivery catheter. Delivering the anchor over the guidewire may provide improved control in the delivery and placement of the anchor within the right ventricle.

Core Innovation

The invention relates to a system for treating a heart of a patient that uses a guidewire insertable through a first wall of the heart into a chamber of the heart, and a delivery catheter insertable over the guidewire through the first wall. A first anchor includes a lumen configured to receive the guidewire so the first anchor is insertable over the guidewire through the first wall via the delivery catheter. A tension member coupled with the first anchor urges the first wall against a second wall, and a second anchor is slidably coupled with the tension member.

The second anchor is operable in a variable force mode and a set force mode, where the variable force mode allows the second anchor to slide proximally and distally along the tension member and the set force mode inhibits movement of the second anchor proximally or distally along the tension member. The guidewire is axially insertable through the lumen of the first anchor to maintain a low profile configuration in which the first anchor and lumen align with an opening of the first wall and with the delivery catheter. The guidewire is removable from the lumen of the first anchor to reorient the first anchor to a deployed configuration in which the first anchor and lumen are not aligned with the opening of the first wall.

A channel is formed at a distal end of the delivery catheter such that the channel is configured to receive the first anchor and expose at least a portion of the first anchor to an environment surrounding the delivery catheter. The channel and delivery catheter are configured so that positioning the guidewire within the lumen secures the first anchor within the channel, and removal of the guidewire allows removal of the first anchor from the channel. In related systems, an anchor receptacle disposed at a second end of a delivery catheter positions an anchor on a side of the delivery catheter, with the anchor deliverable in a radial direction relative to an axis of the delivery catheter and releasably locked in a low profile configuration using a release wire.

The release wire is positionable through the lumen of the anchor and through the lumen of the delivery catheter on a proximal side and on a distal side of the anchor receptacle to releasably lock the anchor in the low profile configuration aligned with an opening of the wall of the heart. Removal of the release wire unlocks the anchor from the anchor receptacle to allow delivery radially from the anchor receptacle and reorientation to a deployed configuration in which the anchor and lumen are not aligned with the opening of the wall. The disclosed system further includes variable force mode and set force mode for the second anchor and mechanisms for applying anchor force using an axial force-application tool, including from outside the patient through a minimally invasive access tool.

Claims Coverage

The partial claims provided include two independent claims, each describing an over-the-wire catheter-based heart treatment system with a tension member and an anchor arrangement that can transition between low-profile alignment and deployed reorientation, while also incorporating variable force mode and set force mode for anchor motion control. Across the independent claims, inventive features include guidewire-guided low-profile anchoring, forced wall-to-wall urging using a tension member, mode-switching inhibition of anchor sliding, and channel/receptacle-based confinement and radial deployment using a removable guidewire or release wire.

Across the independent claims, the coverage centers on a guidewire- or release-wire-controlled catheter system that places an anchor in a low profile configuration aligned with an opening in a heart wall, then reorients it to a deployed configuration by removing the guidewire or release wire. The system uses a tension member to urge one wall against another and includes a second anchor that can transition between variable force mode and set force mode to control sliding movement along the tension member, with additional dependent refinements directed to force application and delivery catheter structural features.

Stated Advantages

Documented Applications

No documented applications found