Method and apparatus for antegrade transcatheter valve repair or implantation

Inventors

Fischell, Tim A. • Saltiel, Frank

Assignees

Vantis Vascular Inc

Abstract

Methods, apparatuses, and systems for performing a valve replacement or repair. Apparatuses may include systems and may include an outer catheter, one or more interchangeable inner catheters, a guidewire and an expandable chordae tendinae deflector. Also described herein are rapid pacing sheaths that may be used with any of these apparatuses and methods.

Core Innovation

The invention relates to a system for antegrade delivery of a replacement valve that includes an outer catheter configured as a sheath to receive an inner catheter. The elongate outer catheter body is configured to extend from outside of a body to a left ventricular apex of the heart, with a hub at a proximal end comprising a hemostatic valve. A plurality of electrodes at a distal end region of the elongate body and a plurality of electrical connectors extending proximally from the elongate body are electrically connected through conductor cables to apply electrical heart pacing stimulation via the electrodes during valve delivery.

The invention further provides an antegrade delivery architecture in which the outer catheter is configured to receive an inner catheter that has a distal end region that is tapered and an engagement surface proximal to a distal end of the inner catheter. The engagement surface is configured to sealingly couple to a distal end region of the outer catheter so that an outer surface of the inner catheter is flush with an outer surface of the outer catheter without a gap. The same system includes a pacing controller configured to couple to electrical connectors and to apply heart pacing stimulation from the electrodes.

The disclosed systems also include specific electrical routing and electrode placement features, including a plurality of conductor cables forming a bundle extending helically around the elongate body from the plurality of electrical connectors to the plurality of electrodes, with the electrical connectors electrically connecting to corresponding electrodes. The electrodes may be arranged along a distal end region and may be spaced from the distal end region by a standoff distance, with ring electrodes circumferentially arranged around the distal end region. Additional structural features described include a plurality of electrodes spaced from each other by a range between about 1 cm and 9 cm and, in some embodiments, an outer catheter with a side port in fluid communication with the lumen.

Claims Coverage

The partial content identifies two independent claims, each covering an antegrade delivery system for a replacement valve with a pacing sheath/outer catheter and an inner catheter configured for sealing flush coupling, and with a pacing controller delivering heart pacing stimulation through distal electrodes. The dependent claims add multiple structural and electrical refinements, including connector and coupling geometry, electrode layout, spacing, and optional fluid features.

Across the independent claims, the core claim coverage centers on an antegrade replacement-valve delivery system that uses an outer catheter/sheath extending to a left ventricular apex with a hemostatic hub, distal electrodes, proximal electrical connectors, and a pacing controller that delivers heart pacing stimulation through the electrodes. The coverage further emphasizes sealing flush coupling between a tapered inner catheter and the distal region of the outer catheter without a gap, together with electrical conductor routing via helically bundled cables and specified electrode arrangements/spacing refinements in dependent claims.

Stated Advantages

Documented Applications